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www.chemicalsknowledgehub.com INSIDE ...
● Life Sciences Focus
● Catalysis
Chemicals ● Topical Products
● Cosmetics
Knowledge ● Digital Technology
Hub ● Distribution
Connecting industry across the globe ● Automotive Industry
● Water Treatment
● Contract Services
Summer 2020 www.chemicalsknowledgehub.com
Summer 2020 1
www.chemicalsknowledgehub.com
Azelis expands its global
presence into Latin America
Azelis is thrilled to announce the acquisition of
Megafarma, Mexico’s premier specialty distributor
for the pharma, food and veterinary industries.
The addition of Megafarma into the Azelis global Megafarma, headquartered
network strengthens our commitment to our valued in Mexico City, with offices in
principals and customers across Latin America, and Guadalajara and Monterrey,
is complementary to our strategy of sustainable represents some of the world’s
organic growth. The transaction also creates a most renowned raw material
platform to build other market segments in Mexico, producers and serves a large
such as plastics, foam, CASE, personal care, and number of customers throughout
household & industrial cleaning. all regions of Mexico.
visit azelis.com/americas
megafarma.com.mx
2 Summer 2020
www.chemicalsknowledgehub.com Contents
Welcome .................................................................................................................................................................................... 3
Events
Events Calendar 2020 ......................................................................................................................................................... 4-5
Industry News .......................................................................................................................................................... 6-14
Life Sciences Focus: Drug Discovery ................................................................................ 16-17
6 Gene editing and gene modulation technologies support drug discovery
Life Sciences Focus: Drug Development ...................................................................... 18-19
Adopting a phase-appropriate approach to solid-state pharmaceutical chemistry
Life Sciences Focus: Drug Delivery .............................................................................................. 20
The growing field of nanoencapsulation in pharmaceutical and cosmetics applications
Life Sciences Focus: Process Development .................................................................... 22
16 Continuous manufacturing and the personalized medicine revolution
Life Sciences Focus: Biotherapeutics......................................................................................... 24
Avacta Group: in the forefront in the fight against coronavirus
Life Sciences Focus: Supply Chain Management ................................................... 26
Managing the triple threat - how Life Sciences can build pandemic-ready supply chains
Catalysis ................................................................................................................................................................................ 28
22 Biocatalysis – How secret should it be?
The case for homogeneous ester hydrogenation
Topical Products ......................................................................................................................................................... 33
Topical drug formulation: the challenges and new solutions
Cosmetics ............................................................................................................................................................................ 36
Eigenmann & Veronelli - Creating value for customers in chemical manufacture and
distribution for more than 100 years
24 Hi-tech cosmetics products and services give an individual look
Capturing the essence of Africa
Digital Technology .................................................................................................................................................. 42
Building resilience with the digital twin
Distribution ....................................................................................................................................................................... 44
Azelis: innovative service provider on a global basis
Automotive Industry ............................................................................................................................................ 47
33
Let’s drive forward to the future
Water Treatment ....................................................................................................................................................... 50
Ozone and oxygen for sustainable odour and corrosion control
Contract Services .................................................................................................................................................... 55
Outsourcing as a key to success
Guidelines ............................................................................................................................................................................ 56
36 Do you have something to say?
Summer 2020 1
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Providing
chemistry
expertise to
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to life
Scientifically led and commercially minded, we are your
dependable and trusted partner for innovation. We develop
perfect-for-purpose chemistry solutions from lead optimisation
through to product launch and life-cycle management.
This enables our customers to create affordable, best-in-class
small molecule therapeutics in an economically and
environmentally sustainable way.
Discover more catsci.com
l Get in touch enquiries@catsci.com
2 Summer 2020
www.chemicalsknowledgehub.com Editorial
elcome to the Summer 2020 issue of Chemicals such faith in us throughout this year. Our
W Knowledge Hub. In this issue we have a strong
focus on life sciences which is in anticipation
of our new life sciences section. We are also
editorial contributors, our advertisers,
our readers and our partners – thank
you all for helping us to be such a rapid
delighted to bring you some great articles on pharmaceuticals success in the speciality chemicals
and cosmetics, as well as our regular sections on distribution, communication arena. So please do
water treatment and some insights into the automotive stay with us, keep reading our news and
industry. articles, and let’s see together what a
I’m delighted to announce the launch of CKH TV, the one- thrilling future our industry will bring”.
stop-shop for industry interviews and insights. This is your
platform to showcase your products, services and expertise
to the industry. This unique video content platform is the best
place to be seen and see what’s hot in the chemicals industry! Publishing Director
I want to thank most sincerely everyone who has shown Chemicals Knowledge Hub (Global)
PUBLISHING DIRECTOR
Ellie Bruni
Don’t miss the Autumn
T: +44 (0) 7872 516194 E: ellie.bruni@ckhglobal.org
ADVERTISING
2020 issue of CKH
Kenneth Carroll
T: +1 (610) 745-1426 E: ken.carroll@ckhglobal.org
Tom Scanlan
T:+1 (847) 624-8925 E:tom.scanlan@ckhglobal.org
Nadia Liefsoens
T: +32475593196 E:nadia@fivemedia.be
EDITORIAL CONTACT
Please send your news and suggestions for feature articles to the editorial team
at Editor@ckhglobal.org
Chemicals Knowledge Hub is published by BIBO Publishing SL Av.
Diagonal, 409, 1St Floor, 08008, Barcelona, Spain
Disclaimer
BIBO Publishing SL will not be held responsible or liable for errors
or omissions supplied or contained in this publication, although due
care and attention are taken to ensure all content is accurate at the
time of going to press. Speciality World Media Ltd also will not be held
responsible for any false claims made by advertisers, or in articles
contributed by external authors. The views and opinions expressed are
not necessarily those of the Editor or BIBO Publishing SL.
Copyright EDITORIAL:
IAL Elli
Ellie B
Brunii
The contents of this publication are copyright © BIBO Publishing SL T: +44 (0) 7872 516194 E: ellie.bruni@ckhglobal.org
2020. No part of this publication can be reproduced or transmitted in
ADVERTISING: Kenneth Carroll
any form without the express permission of the publisher.
T: +1 (610) 745-1426 E: ken.carroll@ckhglobal.org
ISSN 2516-4481 Tom Scanlan
T: +1 (847) 624-8925 E: tom.scanlan@ckhglobal.org
Nadia Liefsoens
T: +32 475 593196 E: nadia@fivemedia.be
Summer 2020 3
Events www.chemicalsknowledgehub.com
Events Calendar 2020
CPhI Korea in-cosmetics Asia Bio Integrates
26-28 August 2020 NEW DATES! 3-5 November 2020 VIRTUAL EVENT!
Seoul, Korea Bangkok, Thailand 16 November 2020
www.cphi.com/korea/ https://asia.in-cosmetics.com www.lifescienceintegrates.com
Adhesive and Bonding Expo CPhI South East Asia Pharma Integrates
VIRTUAL EVENT! 4-6 November 2020 NEW DATES!
VIRTUAL EVENT!
28 August 2020 Muang Thong Thani, Thailand 17 November 2020
www.adhesivesandbondingexpo.com www.cphi.com/sea www.lifescienceintegrates.com
TIDES USA Oligonucleotide & In cosmetics formulation summit CPhI india
Peptide Therapeutics 25-27 November 2020
11-12 November 2020
VIRTUAL EVENT! Delhi, India
London, United Kingdom
15-18 September 2020 https://www.cphi.com/india/
https://informaconnect.com/tides/ TIDES EUROPE:
Oligonucleotide & Peptide CPhI China
Festival of Pharma VIRTUAL EVENT! 16-18 December 2020
VIRTUAL EVENT!
10-13 November 2020 Shanghai, China
16 October 2020
https://informaconnect.com/ tides-europe/ www.cphi.com/china
MedTech Integrates Chemspec Europe APAC Biopolymer Summit 2020
VIRTUAL EVENT! 11-12 November 2020 NEW DATES! 16 – 17 September 2020
15 October 2020 Cologne, Germany Kuala Lumpur,
www.lifescienceintegrates.com www.chemspeceurope.com Malaysia
4 Summer 2020
www.chemicalsknowledgehub.com Events
Speciality & Custom CPhI Japan in-cosmetics Korea
Chemicals America 14-16 April 2021 NEW DATES! 14-16 July 2021
9-11 February 2021 Osaka, Japan Coex, Seoul, South Korea
Fort Worth, USA www.cphi.com/japan https://korea.in-cosmetics.com
www.chemicalsamerica.com/
CPhI North America Speciality & Agro
DCAT Week 2021 April 20-22, 2021 NEW DATES! Chemicals America
22-25 March 2021 Philadelphia, USA 29 June-1 July 2021
New York, www.cphi.com/northamerica Charleston, USA
USA www.chemicalsamerica.com
https://dcatweek.org/ Interphex
in-cosmetics Latin America
20-22 APRIL 2021 NEW DATES!
22-23 September 2021
CPhI middle east NEW DATES! New York City, USA
24-25 March 2021 Sau Paulo, Brasil
www.interphex.com/
Riyadh, https://latinamerica.in-cosmetics.com
Saudi Arabia BIO International Convention
CPhI worldwide
www.cphi.com/mea June 14-17, 2021
Autumn 2021
Boston, USA
in-cosmetics global https://www.cphi.com/Europe
https://www.bio.org
13-15 April 2021 NEW DATES!
Barcelona,
For more information about these and other events in the
Spain
speciality chemicals industry, visit
www.chemicalsknowledgehub.com/events
www.in-cosmetics.com/global/
Summer 2020 5
Industry News www.chemicalsknowledgehub.com
Cambrex increases flexible manufacturing
capacity at Karlskoga facility
S-headquartered Bjarne Sandberg, Managing
U pharmaceutical CDMO
Cambrex is investing $3.6
million at its Karlskoga,
Sweden facility to increase flexible
drug substance manufacturing
Director, Cambrex Karlskoga. “This
investment, as with others made by
Cambrex across our global network,
is in line with the company strategy
of ensuring that the assets we
capacity. The work, which will can offer customers allow for the
convert a previously customer- most cost-effective and efficient
dedicated manufacturing train, will manufacturing.”
include an additional production line Cambrex’s site in Karlskoga
at 6 cubic metre scale being added employs more than 400 people and
at the site resulting in a 25 per cent features a wide range of flexible
Cambrex: investing in added flexible manufacturing capacity at its
capacity increase at the facility. manufacturing facilities, including
Karlskoga facility in Sweden.
Engineering work for the four cGMP pilot plants and five full-
expansion has already commenced new holding tanks and a 4 square quality European and US partners, scale commercial production units.
at the facility and is expected to be metre Hastelloy Rosemund filter. so we must ensure capacity is In 2019, a new 600 sqare metre
completed by November this year. “We are seeing continued both flexible and available to be process and analytical development
The work involves modification growth in commercial-scale API in a position to react quickly and facility was added to the site, along
of an existing four-reactor manufacturing, and an ongoing effectively to customers’ changing with a 3,000 square metre logistics
configuration and the installation of trend for customers favouring high- requirements,” commented centre.
Piramal Pharma Solutions
acquires solid dose facility
from G&W Laboratories Inc
Piramal Enterprises Limited’s Pharma capabilities in solid oral dosage
Solutions (PPS) has entered into an forms were all located in the UK
agreement with G&W Laboratories and India. The Sellersville site
Inc. to acquire G&W’s solid oral can also produce liquids, creams,
dosage drug product manufacturing and ointments, further expanding
facility in Sellersville, Pennsylvania. the PPS portfolio and the site
Under the agreement, PEL, through also can support product and
BASF working toward circularity one of its affiliates, would acquire at process development for solid oral
closing a 100 per cent stake in the dosage and oral liquids, including
in recycling of mattresses entity that operates the facility and immediate release, modified
BASF has developed a chemical new ground and responding to owns the related real estate. release, chewable and sublingual
recycling process for used the raised expectations regarding The acquisition will add solid oral solid oral dosage forms, solutions
mattresses and is starting sustainability of the foam and dosage form capabilities in North and suspensions in liquids. The site
pilot tests at the company’s mattress industry as well as those America to PPS’s manufacturing has received certifications from the
Schwarzheide site in Brandenburg, of consumers and that this is an portfolio: until now, the company’s FDA and the EMA.
Germany. The materials from old important step to possibly re-enter
mattresses are to be recycled post-consumer waste back into
in such a way that they can be product lifecycles.
used for the production of new BASF’s process breaks
mattresses. “The target is to down the flexible polyurethane
recover the raw materials with a and delivers the initially used
quality comparable to that of non- polyol. From there the company
recycled/virgin raw materials”, said can produce new foam with
Shankara Keelapandal, Business a significantly lower carbon
Management Isocyanates Europe. footprint, because fewer fossil
The company says it is breaking resources are used. G&W Laboratories’ Sellersville, Pennsylvania facility in the US will
shortly be acquired by Piramal Pharma.
6 Summer 2020
www.chemicalsknowledgehub.com
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Summer 2020 7
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LANXESS increasing its use Catalent expands beauty and plant-
of recycled raw materials for based consumer health Softgel
thermoplastics and composites capabilities in Canada and Brazil
Delivery technologies specialist plant-based softgel technologies
peciality chemicals HPM’s primary target for Catalent has completed a $3.2 growing by more than 25% globally
S company LANXESS is
increasingly making use of
recycled raw materials in
the production of its thermoplastic
compounds and composites
the three new compounds is
the automotive industry. “For
instance, Durethan ECOBKV60XF
offers exceptional strength and
rigidity, which makes it suitable
million expansion programme at
its consumer health manufacturing
facilities in Strathroy, Canada and
Sorocaba, Brazil. The expansion
projects include new softgel
in recent years,” commented Dr
Aris Gennadios, President, Softgel
& Oral Technologies, Catalent.
“Additionally, Brazil has grown to
become the world’s fourth-largest
with the company’s Durethan for manufacturing structural encapsulation lines at each site, market for beauty care products.
ECOBKV30H2.0, ECOBKV35H2.0 components such as front ends, dedicated to Catalent’s proprietary While we have been supplying the
and ECOBKV60XF products as the pedal bearing brackets and A-, B- Vegicaps® plant-based capsule North and Latin American markets
most recent examples of product and C-pillars, as well as lightweight and CosmoPod® twist-off capsule with plant-based softgel capsules
manufacturing being performed battery trays for electric vehicles,” technologies. The company from our manufacturing sites in
in line with this strategy. Recycled explains Margraf. says the increased capacity will Italy and Germany, this investment
fibres manufactured from waste HPM is going to be gradually enable it to support its customers allows us to provide local
glass make up 30%, 35% and increasing the number of in North and Latin America to supply solutions to markets that
60% by weight respectively of ECO product types certified in develop products for consumers complement existing capabilities in
these three new polyamide 6 accordance with Ecocycle’s mass seeking all-natural and plant- Europe.”
compounds and independent balance method and is planning based vitamins, minerals and Catalent’s 110,000 square-
inspection company Ecocycle has to launch a new polyamide 6 with supplements using its Vegicaps foot facility in Strathroy, Ontario,
awarded LANXESS an ecoloop a glass fibre content of 30% and capsule; and support those and its 124,600 square-foot
certificate in accordance with ISO a reduced carbon footprint. The customers looking for innovative, facility in Sorocaba, Brazil, both
14021:2016. The glass comes caprolactam required to produce easy-to-use, unit-dose beauty care offer a broad range of integrated
from waste left over from glass this more environmentally friendly products through its CosmoPod formulation, manufacturing, and
fibre production. polyamide 6 is based on a selection technology. packaging services to provide full-
“We want to help make the of petrochemical raw materials “We have seen increased service turnkey solutions for the
switch from a throw-away society that support this aim. HPM is not consumer demand for greater pharmaceutical, consumer health,
to a circular economy,” stated Dr currently using waste glass fibres product choice, with sales of and beauty industries.
Guenter Margraf, global product from end-of-life components, but
manager at LANXESS’s High does view them as a particularly
Performance Materials (HPM) sustainable raw material for Almac Group launches Tempod
business unit. “Our goal is to make use in manufacturing new glass
more and more of our plastic fibres. “Using waste glass cuts 1000 to improve clinical site
products sustainable so that we can
make our growth less dependent on
down on the use of resources as
well, because it saves glass raw
temperature data management
the consumption of finite resources, materials,” says Margraf. “It also Almac Clinical Services has due to disruptions caused by the
improve our carbon footprint and means there’s no need to dispose launched Tempod® 1000 as part of global pandemic. The Tempod
protect the environment,”. of the waste glass.” the company’s site compliance and 1000 automates the process by
temperature management offering. continually recording temperature
Tempod 1000 is a USB device that data for drug products stored at
captures and stores all clinical site clinical sites, providing sponsors and
temperature data and automatically CRAs with full, remote visibility to
identifies unreported excursions ensure quality and integrity of the
once uploaded into Almac’s drug product.
TempEZ Web-based temperature Almac Clinical Services says
management software. Designed to that, in addition, Tempod 1000 will
remove the administrative burden of reduce the risk of missed patient
updating manual temperature logs, it visits due to unreported excursions,
also increases site compliance with enable sponsors and CRAs to
reporting data and promotes best identify and resolve excursions
digital practice in clinical studies and remotely, speed-up CRA review time
patient safety, the company says, during site visits, and facilitate timely
LANXESS using waste glass at its glass fibre production facility in adding that manual methods of data and efficient study close-outs and
Antwerp, Belgium. (Photo: LANXESS AG) capture have proved challenging database locks.
Summer 2020 9Industry News www.chemicalsknowledgehub.com
Biesterfeld opens new Grace introduces novel
Lab and Innovation Centre matting agents for water-
peciality chemicals and based wood coatings
S product formulation
company Biesterfeld is
expanding its laboratory
capacities in Hamburg, Germany
with the opening of the Biesterfeld
Speciality silicas producer W. R.
Grace & Co. has introduced two
new premium matting agents
especially designed for eco-friendly
with high chemical resistance
and clarity and the two silicas
can be used alone or blended to
achieve desired appearance and
Lab and Innovation Centre. systems in water-based wood performance attributes. Grace says
Covering a total area of 800 coatings: SYLOID AQ 800 silica and that SYLOID AQ silica series’ proof-
sq m, the premises will be SYLOID AQ 880 silica. Specifically of-concept and extensive in-market
used with immediate effect for developed to ensure an extremely beta tests have demonstrated
application-related laboratory low-gloss finish, these new patent- “vast” performance improvements
activities. These include the pending speciality silicas have been and formulation advantages over
development of innovative and designed to eliminate the typical alternative matting agents.
market-oriented formulations, water spots and stains that wood The SYLOID AQ silica series has
carrying out of product tests and coatings manufacturers strive to been designed to be simple to use,
customer-specific project work. avoid. with low dusting properties and
The Biesterfeld Group also has SYLOID AQ 800 and SYLOID AQ easier dispersibility, translating into
regional laboratories in Norway, 880 silicas have been designed to shorter cycle times and potential
Turkey and Poland. offer superior matting properties cost savings.
An existing laboratory in Biesterfeld is expanding its
Hamburg has been integrated into laboratory facilities in Hamburg,
the new application laboratory to Germany to support product
make the new Biesterfeld Lab and development.
Innovation Centre. The premises
also contains a conference room and thus support marketing
and a modern presentation and work,” comments Dr Lisa
meeting area, which can be used Nahrwold, Laboratory Manager
for product launches and technical at Biesterfeld Spezialchemie.
training sessions. “Alongside individual project work
“In our application laboratories in accordance with customer
we develop tailored solutions requirements, the laboratory
to cater for the needs of our will be used to screen new raw
customers. An innovative materials from our partners and
formulation, for example, can to conduct comparative studies.
be made market-ready through Comprehensive regulatory Grace’s new SYLOID AQ 800 and SYLOID AQ 880 silica matting
the addition of additives from consulting rounds off our range of agents are designed to ensure an extremely low-gloss finish for
our wide-ranging portfolio services.” wood coatings.
Syngenta Group launched to create global agtech market leader
Syngenta Group Co. Ltd. has 48,000 employees in more than Group offers comprehensive Airport City, Israel and Syngenta
announced the official launch of 100 countries, and had sales of agronomic solutions and digital Group China, led by Hengde Qin
Syngenta Group as a single entity $23 billion in 2019. agricultural services, operating 15 based in Shanghai, China.
to create a new global leader in From its inception, Syngenta key production sites. Erik Fyrwald, formerly CEO of
agricultural science and innovation Group is the global market leader Under its new structure, the Syngenta AG, becomes Syngenta
that combines the strengths of in crop protection, the global organization encompasses four Group CEO; Chen Lichtenstein,
Syngenta AG, headquartered number three in seeds, the business units: Syngenta Crop formerly CEO of ADAMA, becomes
in Switzerland, ADAMA, based market leader in fertilizer in China Protection, led by Jon Parr based Syngenta Group CFO; Steve
in Israel, and the agricultural and, with its Modern Agriculture in Basel, Switzerland; Syngenta Landsman becomes Syngenta
businesses of Sinochem, Platform (MAP) Farmer Solution Seeds, led by Jeff Rowe based Group General Counsel, and Laure
based in China. The new entity, Centers, a leading agriculture in Chicago, USA; ADAMA, led Roberts becomes Syngenta Group
headquartered in Switzerland, has services provider in China. The by Ignacio Dominguez based in Chief Human Resources Officer.
10 Summer 2020www.chemicalsknowledgehub.com Industry News
NOVA Chemicals and Enerkem
collaborate on plastics recycling
wo Canadian companies indistinguishable from those made
T are to collaborate on
innovative technology
to close the loop on
recycling and drive a plastics
circular economy. NOVA Chemicals
from 100 percent virgin, fossil-
based feedstocks.
Enerkem is the first company in
the world to produce renewable
methanol and ethanol from
Corporation, a leading producer of non-recyclable, non-compostable
chemicals and plastic resins, and municipal solid waste at full
Enerkem Inc, a leading waste-to- commercial scale. Its current
renewable fuels and chemicals technologies replace the use of
producer, have entered into a fossil sources like petroleum and
Canadian companies NOVA Chemicals and Enerkem Inc have
joint development agreement to natural gas to produce sustainable
formed a joint development agreement to explore turning non-
explore turning non-recyclable fuels and chemicals that are used
recyclable and non-compostable municipal waste into ethylene, a
and non-compostable municipal in a broad range of everyday
basic building block for plastics
waste into ethylene, a basic products.
building block for plastics. The commercial scale. The companies are a necessary component of NOVA Chemicals is committed
companies will research advanced say ethylene produced from waste moving to zero plastic waste by to enabling 100 per cent of
recycling technology to transform would advance a plastics circular creating valuable new feedstocks plastics packaging is recyclable
hard-to-recycle municipal waste, economy and help meet consumer from post-use plastics that cannot or recoverable by 2030; and 100
including items such as plastics, brand goals for recycled content in be easily mechanically recycled and per cent of plastics packaging is
household waste, and construction packaging. the quality of polymers produced re-used, recycled or recovered by
materials, into ethylene at full Advanced recycling technologies with advanced recycling products is 2040.
Bionema secures Innovate UK grant to complete
development of microencapsulation technology
Bionema Ltd, a leading UK-based effective control of pests, such
biotechnology company, has as western flower thrips, aphids,
received a grant from Innovate UK whitefly and spider mites, requires
to support the company’s continued a robust formulation for targeted
development of its bioinsecticide delivery. Currently, these pests
microencapsulation formulation, are controlled by conventional
which, the company says, delivers chemical insecticides but some of
an effective alternative to chemical them have now developed product
pesticides. This additional £98,000 resistance, while other products
Continuity Grant complements have been removed from the
an initial £1.0 million in funding market, due to their harmful impact
support from Innovate UK, the on the environment and human
national funding agency that invests health. Ansari says that biopesticide
in science and research in the UK, formulation and its targeted delivery Dr Minshad Ansari of Bionema: developing new
and from the Welsh Government’s is a more stable and sustainable microencapsulation formulation and delivery systems as the basis
SMART Cymru. approach for controlling these pests of increasingly effective biopesticide products.
Dr Minshad Ansari, a world- which are causing billions of dollars
leading biopesticideexpert of crop damage on a world-wide be registered and distributed University of Birmingham and at
who leads Bionema’s research scale. across Europe, the US and Canada. Bionema. In addition to Bionema’s
team, commented: “The funding The Continuity Grant-funded Currently, trials are in place with research, development and
is helping the company to project aims to develop a unique several multi-national chemical commercial teams, Silsoe Spray
continue the development of its manufacturing process of proven companies and distributors to Application Unit is also testing the
microencapsulation formulation and microencapsulation formulation commercialize the technology. product’s large-scale applicability
deliverysystems, which is crucial technology for next-generation The project team includes and Applied Insect Science, a
to the developmentof effective bioinsecticide control. New formulation experts from the School regulatory service, is managing the
biopesticide products,” adding that microencapsulated products will of Chemical Engineering at the registration of the product.
Summer 2020 11Industry News www.chemicalsknowledgehub.com
Mergers & Aquisitions Catalent completes purchase
LANXESS completes acquisition of
of pharmaceutical packaging
Brazilian biocide manufacturer IPEL facility in Japan
LANXESS has completed the acquisition of Brazilian biocides
Catalent has completed the role in its expanding Asia-Pacific
manufacturer Itibanyl Produtos Especiais Ltda. (IPEL). Headquartered in purchase of Teva-Takeda network, working alongside two
Jarinu, São Paulo, IPEL is one of Brazil’s leading biocide manufacturers Pharmaceuticals’ packaging facility sites in China and one in Singapore
and generated sales in the lower double-digit million dollar range in in Minakuchi, Shiga Prefecture, to support customers’ clinical trials
2018, with about 100 employees. IPEL generates the majority of its sales Japan. Operating in partnership with across the region.
through biocides and speciality chemicals for the paints and coatings the company’s existing Japanese The facility will offer extensive
industry. The company’s product portfolio also includes preservatives clinical supply facility located in clinical supply services including
and fungicides for process control in water treatment as well as active Kakegawa, the new 60,000-square- access to Catalent’s FastChain
ingredients for disinfection and cleaning agents. foot facility will provide customers demand-led supply services,
with flexible clinical supply solutions, primary and secondary packaging
Gilead Sciences to acquire interest serving both local customers and capabilities, and a range of
in Pionyr Immunotherapeutics global biotech and pharmaceutical temperature options for storage
Gilead Sciences, Inc is to acquire a 49.9% equity interest in Pionyr companies. Catalent stated that and distribution, as well as clinical
Immunotherapeutics Inc for $275 million with an exclusive option to the facility would play an important returns and destruction services.
purchase the remainder of Pionyr, a privately held company developing
first-in-class cancer immunotherapies. Under the agreement, Pionyr’s SOCMA on-demand training
shareholders may receive up to an additional $1.47 billion in option
exercise fees and future milestone payments. Pionyr’s Myeloid Tuning for chemical operators
therapies have the potential to treat patients who currently do not benefit SOCMA, the Society of Chemical Dettinger, Senior Director, Compliance
from checkpoint inhibitor therapies and the company’s PY314 and PY159 Manufacturers and Affiliates, reports & Stewardship at SOCMA. “Having
candidates have demonstrated preclinical efficacy, suggesting potential in that since its launch in January, 15 led EHS&S operations at a facility
solid tumours in combination with established anti-PD(L)-1 agents. Pionyr companies across 42 facilities have for many years, I understand the
plans to file investigational new drug (IND) applications with the FDA for adopted its Chemical Operations importance of thorough training and
both candidates in the third quarter of this year. Pending Phase 1b results Training Tool to train and refresh the need to safely onboard operators
from either candidate, or sooner if Gilead chooses, Gilead can exercise its employees on standard operations and about the mechanics behind each
exclusive option to acquire the remainder of Pionyr. processes in chemical manufacturing process.”
and that SOCMA is now expanding Companies that have implemented
KRAHN Chemie acquires Greek distributor this modernized training tool to non- the modernized platform found the
KRAHN Chemie GmbH has acquired a majority share of InterActive SA, member manufacturers. tool to be an efficient resource for
“SOCMA developed this both in-person and remote training.
headquartered in Athens, Greece. Through this strategic acquisition, the
comprehensive programme with Further information can be found at
KRAHN Chemie Group has expanded its footprint not only in Europe but
on-demand training in mind,” said Joe www.socma.org
also to cover the Israeli market. InterActive SA was founded in 1990 and
specializes in the distribution of lubricant additives in the Israeli, Greek
and Cypriot markets, as well as scientific instruments for R&D and QC
Eastman partners with IMCD Group
laboratories in the oil, pharma & chemical industries by representing to expand EMEA speciality plastics
international manufacturers.
distribution network
Eppendorf acquires centrifuge Eastman Chemical is expanding and also start serving an expanded EMEA
business of Koki Holdings Co, Ltd reinforcing its strategic partnership market comprised of more than 30
Eppendorf AG and Koki Holdings Co, Ltd, have reached an agreement with IMCD Group for the distribution countries.
that Eppendorf will acquire the Japanese company’s centrifuge business, of its speciality plastics. The company “IMCD is already a strategic
including the premium himac brand. The acquisition marks a targeted offers the world’s largest portfolio of partner in the distribution for various
step by Hamburg, Germany-based Eppendorf AG to expand its centrifuge thermoplastic polyester materials and Eastman speciality materials,
business, solidifying its strong market position as one of the world’s leading IMCD will distribute these products with demonstrated synergies and
makers of high-end centrifuges for the pharmaceutical and life science over a wide range of markets and processes alignment,” said Eastman
industries as well as for academic and commercial research. Koki Holdings applications, including medical, sales director Oliver Osborne. “We
said that it will focus on developing its position as a comprehensive provider consumer durables, cosmetics, believe this expanded partnership
of power tools aiming to become a leading global company through personal care, and packaging, will ensure a smooth transition for
strategic investment, accelerated technology and product development. amongst others. Currently, IMCD our speciality plastics customers
Koki Holdings Co, Ltd, develops and produces ultracentrifuges and floor- distributes Eastman speciality plastics whose distribution arrangements with
standing centrifuges under the brand name himac. in Spain and Portugal and under the incumbent distribution partners finish
new distribution agreement, IMCD will at the end of July.”
12 Summer 2020www.chemicalsknowledgehub.com
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MFG Chemical obtains ISO 9001: 2015
Certification for Pasadena, Texas plant
S-based speciality and regulatory requirements.
U and custom chemical
manufacturer MFG
Chemical has achieved
ISO 9001:2015 Certification for
its 26.7 acre plant in Pasadena,
ISO 9001 is based on the plan-
to-check-act methodology and
provides a process-oriented
approach to documentation and
reviewing the activities. As part of
Texas, completing certification for the ISO9001:2015 certification
all four of the company’s plants, the process, MFG Chemical engaged
other three being located in Dalton, in a rigorous audit of its business
Georgia. MFG was one of the first processes, as well as its product
chemical companies to achieve ISO quality environments. The
9001:2015 Certification, beginning company said that by maintaining
MFG Chemical’s Pasadena, Texas facility: ISO 9001:15 Certification
in October of 2016, and has now means that all four of the company’s manufacturing facilities are now
this level of certification, MFG
been audited and certified four times. certified to this international quality management system standard.
Chemical is able to demonstrate a
ISO 9001 is the international quality management system and
standard that specifies management system (QMS) and to consistently provide products continuous improvement of its
requirements for a quality is used to demonstrate the ability and services that meet customer products and services.
New Solvay hydrogen peroxide at better serving our customers in
Vietnam,” said Suthichai Srihawan,
dilution and packing plant in Vietnam general manager of Solvay Peroxides
Vietnam “To support sustainability
Solvay Peroxides Vietnam has started local demand for international group’s HS&E standards and now and a circular economy, the use
production at its new hydrogen standard quality hydrogen peroxide high-quality hydrogen peroxides are of returnable packaging has been
peroxide dilution and packing plant for the textile industry and other being supplied by Solvay Peroxythai implemented with our distributors
at Phuc Long Industrial Zone in Long applications. As the first Solvay in Thailand and diluted and packed and customers. This action allows
An Province, Vietnam. The facility industrial facility based in Vietnam, to meet Vietnamese customer customers to minimize the non-
is designed to reach 24,000 ton the plant was built and made requirements locally. ore operation of managing used
capacity per year to meet growing operational in full alignment with the “With this new plant we are aiming packaging.”
People on the Move
AMPAC Fine Chemicals (AFC) has promoted Dr Jeff Butler to the position of President of the company. Dr Butler has performed
in leadership roles of increasing responsibility at AFC, with his most previous position being Vice President of Project Management. In
his new role, he is responsible for operations across all AFC US-based facilities. He holds a PhD in Chemistry from the University of
California, Davis and conducted his post-doctoral research in chemistry at the University of Texas at Austin. He will continue to operate
out of AFC’s Rancho Cordova, California, USA facilities. Dr Jeff Butler
Pierre-Alain Ruffieux will become Chief Executive Officer of Lonza effective November 1, 2020. He is currently Head of Global
Pharma Technical Operations at Roche where he and his 12,000-strong team are responsible for all aspects of pharmaceutical
commercial manufacturing and supply chain operations, technical, quality assurance and regulatory. Prior to that he held roles of
increasing seniority at Novartis and has more than 20 years’ experience in biopharmaceuticals. Pierre-Alain
Ruffieux
Cambrex has named Tom Loewald as its new Chief Executive Officer and a member of the company’s Board of Directors effective
September , 2020, the company being led in the interim by an Office of the CEO comprised of Wayne Hewett, Chairman of the
Board, Robert Green, Executive Vice President and Chief Financial Officer, and Samantha Hanley, Senior Vice President and General
Counsel. Loewald worked for 15-years at Thermo Fisher Scientific, where he served in several senior executive roles, including Chief
Commercial Officer, President of the Analytical Instruments Group, President of the Laboratory Products Group, and President of the Tom Loewald
Laboratory Equipment Division. He currently serves as President of the Flexibles Division of ProAmpac, a leading flexible packaging
manufacturer. Earlier in his career he held leadership positions at Tyco International and General Electric. Loewald currently serves on the Board of
Directors of Harvard BioScience, a global developer, manufacturer and marketer of a broad range of solutions to advance life science.
14 Summer 2020www.chemicalsknowledgehub.com
Where
transformation
begins
Life Science Integrates is excited to announce that this year’s three events :
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Summer 2020 15Life Sciences Focus: Drug Discovery www.chemicalsknowledgehub.com
Gene editing and gene modulation
technologies support drug discovery
Horizon Discovery has developed a broad range of gene editing and gene modulation technologies that enable
scientists to gain a greater understanding of gene function and apply this knowledge to the development of novel
biotherapeutics, gene therapies and diagnostic workflows. This article reviews recent developments at the company.
eadquartered in
H Cambridge, UK and with
offices in the US and
Japan, Horizon Discovery
Group plc specializes in the
application of gene editing and
gene modulation technologies
that support drug discovery and
development within the global
life sciences sector, offering a
portfolio of tools and services
to help scientists gain a greater
understanding of gene function,
identify genetic drivers behind
human disease and deliver
biotherapeutics, cellular and gene
therapies for precision medicine
as well as for the development
and validation of diagnostic
workflows. The company’s
solutions are designed to enable
almost any gene to be altered, or
its function modulated, in human
and other mammalian cell lines.
Its clients include leading
academic institutes,
global pharmaceutical and
biotechnology companies and
Horizon Discovery is now offering an arrayed CRISPR knockout screening service for primary human
clinical diagnostic laboratories.
B cells, cells that are freshly isolated from donors and known to be difficult to study in the lab.
Horizon says that its insight into
Pictured is a B-lymphocyte antibody-producing immune cell. (Image from Shutterstock © Kateryna Kon)
the challenges faced by these
organisations enables it to focus
its efforts on the development of cell lines are optimized to work format. The cell lines are step of generating a stable cell
innovative solutions that not only alongside the company’s Edit-R QC-verified and validated to line and the cost associated
differentiate its offering, but that predesigned synthetic single ensure stable expression and with purchasing a nuclease
also fuel development of the next guide RNA (sgRNA) and CRISPRa functionality of Cas9 or dCas9- could help researchers increase
wave of precision medicines. guide RNA, offering researchers a VPR endonuclease in a range R&D productivity and allow
complete solution to simplify and of common cell backgrounds. novice users to gain a better
Gene knockout and gene streamline CRISPR gene editing Both cell lines are available in understanding of the CRISPR
activation studies and modulation workflows. the same background to enable workflow.
Earlier this month (July 2020), Horizon’s Cas9 and dCas9- loss-of-function and gain-of-
the company introduced its stably VPR stable cell lines were function studies to be performed Production of highly
expressing Cas9 and dCas9-VPR generated using its Edit-R in parallel without the need to complex proteins
cell lines to help accelerate gene Lentiviral particles with a engineer a cell line specifically In a separate recent
knockout and gene activation blasticidin resistance cassette for this purpose. Horizon says development, in May of this
experiments, respectively. The and are provided in pooled that removing the time-intensive year, biopharmaceuticals CDMO
16 Summer 2020www.chemicalsknowledgehub.com Life Sciences Focus: Drug Discovery
proteins to support researchers gene-edited GS knockout CHO B cells, cells that are freshly
from early drug development K1 cell line expression system, isolated from donors and known
through to commercial offered by Batavia Biosciences to be difficult to study in the
manufacturing. as part of its STEP-mAb service, lab. One advantage of working
Horizon says that
The two companies say was used to generate a high with these cells, however, is
its insight into the that by entering into the yielding cell line for Immutep’s that it brings scientists one step
challenges faced by agreement, they aim to empower IMP761 product candidate, an closer to healthy or diseased
these organisations organisations of all sizes, from agonist antibody targeting the micro-environments, enabling
large pharmaceutical companies immune checkpoint lymphocyte them to better understand
enables it to focus to clinical stage biotechs and activation gene LAG-3 which disease etiology and therapeutic
its efforts on the early-stage startups, to drive controls the signaling between mechanisms and thereby
development of efficiencies in biotherapeutic specific immune cells, T cells advance drug discovery and
manufacturing and that Rentschler and antigen-presenting cells development programmes.
innovative solutions
Biopharma’s integrated platform responsible for the adaptive Horizon has already applied
that not only process, together with Horizon’s immune response, making it a its gene editing and cell
differentiate its cell line, will provide innovative promising focus for novel cancer culture expertise to maintain
offering, but that also and tailored solutions to translate therapies or for the treatment of the viability of primary human
complex medical research into autoimmune conditions such as T cells to enable functional
fuel development new biopharmaceuticals, elevating inflammatory bowel diseases, genomic screens and has been
of the next wave of the standard of protein expression rheumatoid arthritis, and multiple delivering data-rich information
precision medicines and allowing clients to access a sclerosis. to customers working in drug
robust and flexible approach for In yet another CHOSOURCE discovery and development.
designer protein therapeutics from platform development, Horizon Horizon says the new B cell
concept to market. announced in April this year screening service, the first of its
that it was offering special kind in the market, will enable
Rentschler Biopharma SE and Immunotherapy licensing terms to facilitate researchers to identify genes that
Horizon signed a commercial development rapid access to the CHOSOURCE affect the function of B cells and
licence agreement under which Horizon had earlier announced for the development of COVID- examine how this impacts other
Horizon’s cGMP-compliant that the CHOSOURCE 19-related therapeutics and immune cell types, particularly
CHOSOURCE platform will platform had played a key diagnostics. Horizon is already in infectious diseases, cancer,
be used in combination with role in generating a stable a key supplier for COVID-19- and auto-immune disorders,
Rentschler Biopharma’s novel cell line for the development related research as a provider of such as COVID-19, Burkitt’s
in-house process for cell line of an immunotherapy for tools and services to academia lymphoma and multiple sclerosis,
development for difficult-to- autoimmune diseases with and industry in their efforts in respectively.
express proteins. Horizon’s pharmaceutical-grade, stable the pandemic.
gene-edited glutamine CHO cells delivering high Further information
synthetase (GS) knockout CHO yields of monoclonal antibody Arrayed CRISPR knockout Horizon Discovery plc
K1 cGMP-compliant cell line for LAG-3 immunotherapy, screening service Cambridge, UK
will complement Rentschler enabling Immutep and Batavia Also in April, Horizon announced Ph: +44-1223-976160
Biopharma’s existing service Biosciences to reach an the addition to its cell-based E: technical@
offering, providing a royalty-free, important milestone in the screening services of an arrayed horizondiscovery.com
state-of-the-art alternative for preclinical development of the CRISPR knockout screening W: www.horizondiscovery.
the production of highly complex compound. The company’s service for primary human com
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Summer 2020 17Life Sciences Focus: Drug Development www.chemicalsknowledgehub.com
Adopting a phase-appropriate
approach to solid-state
pharmaceutical chemistry
Dr Julian Northen, research manager at Onyx Scientific, explains how a more phase-appropriate approach to solid-
state chemistry may present an effective option for drug development teams in assuring the physical properties of
drug products and ensuring optimal drug performance.
he majority of today’s marketed drugs parameters should be identified as markers
T are administered as solids, making solid-
state chemistry a critical component
of pharmaceutical research and
development. The solid-state structure of drug
compounds and their relationship to the drug
for the competing analogues in play. This can
include a simple response to changes in pH and
solubility, Log P, presentation form (oil, solid,
amorphous, crystalline), and whether a salt can
form and aid in isolation/development.
formulation requires full consideration to provide
assurance of the physical properties of the Early development
drug product. A thorough understanding of the During early development, a robust assessment
compatibility of the chosen solid phase with drug of the various solid form versions and
product excipients in the solid state (relative to candidates, such as salt versus API, should
chemical and form stability) is also required to be carried out. This may encompass solubility
avoid the unwanted changes that can occur in across a range of pH, solid stability, solution
pharmaceutical preparations. stability, crystallinity, and thermal properties.
Solid form screening and selection is The choices must also deliver against chemical
important at all stages of drug development. development needs, including robustness
However, with increasing demands on of process, purge of impurity, and process
Dr Julian Northen, research manager at
developers to balance cost pressures with the efficiency. Additionally, an understanding of how
Onyx Scientific
need for fast progression, especially in the the various presentations of each version may
early stages, the industry is calling for more been conducted using the right materials and influence the drug product is also required,
appropriate strategies that pay attention to the in a logical order, progression to first-in-human for instance powder flow, bulk density and
specific requirements at different stages in the studies can be more efficiently achieved. morphology for simple solid dose formulations.
product lifecycle. Despite the advantages of adopting this type The information will provide development
of approach already being understood, there groups with options to consider as material
The advantages of collaboration still exists a culture of solid form selection that transitions through Phase 1. For example, the
There is a growing realization from is less robust. For example, it is not uncommon most soluble salt may not always deliver the
pharmaceutical developers that active for a drug developer to adopt a form or version best option or approximation of bioavailability.
pharmaceutical ingredient (API) development based solely on it being an easy way to isolate Dissolution rate and propensity toward
and manufacturing requires a more interactive a clean solid, or on the chemistry naturally disproportionation and the kinetics of the
approach with collaborative input from multiple delivering the salt or polymorphic form. process will need to be considered along
groups, including medicinal chemists, solid with pharmacokinetic (PK) evaluations that
form scientists, development chemists, and Meeting requirements at different support and enable selection. Ideally, the
formulation scientists. Considering input, stages of development selected version will be maintained through to
objectives and deliverables from different No two drug candidates are the same and the commercial manufacture.
parties can aid the adoption of a more solid-form strategies required for any single API
phase-appropriate approach that will provide will vary over the course of its development. The Late phase
developers with a ‘road map’ to ensure adoption of a phase-appropriate and inclusive During late-phase development it is critical
screening activities become increasingly approach can enable a more predictive pathway to challenge the process in place versus the
comprehensive as the needs and technical that will enable solid form studies to progress necessary specification to ensure that the
requirements at each development stage in a way that ensures specific objectives are solid form of choice delivers routinely against
evolve. The increased understanding that will achieved at different stages. all performance targets. The process would
be gained through having more individuals normally encompass a broader polymorphism
and capabilities involved in the process may Discovery and lead optimization study. This may or may not identify competing
result in considerable time savings when it Starting at the discovery and lead optimization versions that will provide additional protection
comes to selection. If the right studies have stage, a robust set of physiochemical from an intellectual property (IP) standpoint. This
18 Summer 2020You can also read
