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In this issue
Celebrating 60 years 2
New Qube Sterility Isolator delivers
greater efficiency, increased
throughput, and individual
customizations 3
ddPCR quantifies without
calibration curve & determines
absolute DNA concentration 4
Wealth of cGMP experience testing
RNA based drugs 5
Ensuring Sterile Barrier System
integrity for patient safety 6
People are the Chemistry 7
Spring 2021
Bio/Pharmaceutical
NEWS
delivering innovative,
timely and cost effective
scientific solutions to
help customers better
manage their testing
challenges and advance
drug development have
been the catalyst for our
sustained success. We
take a lot of pride in
Celebrating 60 years & 10 with Eurofins what we do and enjoy
working with each
other.
Decade after decade, with growth comes
This year we also celebrate 10 years as part exciting new technology and instrumenta-
of Eurofins Scientific. In 2011 when we tion to deliver the most comprehensive
joined Eurofins, we couldn’t have imagined service offering in the industry. Partnering
a better parent company which held the with our clients’ to meet their ever-expand-
same standards in ethics and customer ing needs allows us to be at the forefront
service. With the help of Eurofins, our of the industry. Just this past year, we’ve
global growth trajectory sky-rocketed. Eu- enhanced capabilities for mRNA COVID-19
rofins Lancaster Laboratories became part vaccine support, rapid mycoplasma testing,
of Eurofins BioPharma Product Testing, the rapid sterility, and surgical mask testing.
largest network of harmonized biopharma- We have added instrumentation like ddPCR,
ceutical GMP product testing labs in the AUC, and MALS for GMP product test-
world with 36 facilities in 19 countries. Fu- ing. We continue to invest in equipment
eled by strong and steady business growth like new sterility isolators and invest in our
the group continued to hire talented staff infrastructure like new lab expansions for
and make strategic investments in capacity Virus Safety, Cell Based Assay, Stability,
and offerings. In 2017 Eurofins Lancaster Product Testing, Category 5, Portage Micro-
Laboratories grew 200 times its original biology Lab, BSL2 labs in San Diego and
size and constructed its 13th and largest Columbia, and a Sterile Fill/Finish lab in
Neal Salerno, President, Eurofins Lancaster
Laboratories Inc., a Eurofins BioPharma building expansion. In addition, the team San Diego. Finally, we also have created a
Product Testing Company created a Medical Device testing business state-of-the-art LIMs system and improved
In 1961, Lancaster Laboratories began its at the site and became part of the Eurofins LabAccess functionality. We’ve done all this
iconic success story in a 2,500 ft2 building Medical Device Testing network which con- to ensure that we may continue to service
on farmland owned by the family of com- sists of over 20 laboratories worldwide. The our customers for the foreseeable future.
pany founders Dr. Earl and Anita Hess. company also realized outstanding growth
and development for its unique client-site Behind the science, equipment and facili-
Lancaster Labs’ seeds of success were ties are our scientists who are the most
firmly planted in the founding principle laboratory management service model, PSS
Insourcing Solutions, which has grown to 85 important element in our chemistry and
that providing personal quality testing ser- the reason for our satisfied clients and
vices in an ethical manner would not only sites in 20 countries with more than 2,000
employees since its inception in 2002. historic success. We are humbled by the
delight clients, but also ensure continued hard work and dedication of each member
record growth and longevity. Six decades Biopharmaceutical service offerings have of our team. Our profound gratitude goes
of a strong work ethic, unrivaled data in- grown exponentially over the last sev- to our clients for choosing us to be part of
tegrity, and unparalleled customer service eral decades as the world’s largest drug their groundbreaking solutions that help
turned a small dream into 1/2 million ft2 developers and manufacturers continue to make the world healthier and safer. Please
state-of-the-art laboratory testing campus, trust our renowned reputation for regula- join us in celebrating 60 years of remark-
employing more than 2,000 and serving tory compliance, technical expertise, and able partnerships and accomplishments.
clients across the globe. impeccable data integrity. Successfully
Bio/Pharmaceutical NEWS 2 Spring 2021
New Sterility Isolator delivers greater efficiency, increased
throughput, and individual customizations
Suzanne Williams, Manager, (QHPV). The external surfaces of client • Maintains a cascading positive
Bio/Pharmaceutical Microbiology samples and media containers as well pressure from the test to the transfer
Experienced and high quality steril- as supplies are decontaminated with modules and then to the ambient
ity testing is in demand, and Eurofins HPV in the QHPV module prior to trans- environment
BioPharma Product Testing’s Micro- fer into the QEXT modules for testing. • Utilizes a touchscreen display user
biology Team responded to growing Samples and supplies are then moved interface
client needs by adding a new isolator, into the QMTD prior to being placed into
incubation. • HPV technology allows for shorter
a Bioquell Qube to its comprehensive decontamination cycles which provides
laboratory suite of isolators. The Qube Installation and Operational Qualifica- the ability to turn around the system in
is an aseptic processing workstation with tion has been performed on the system. a timely manner and to execute more
an integrated Hydrogen Peroxide Vapor In addition, decontamination cycles for decontamination cycles daily
(HPV) decontamination system. the entire empty system as well as the
loaded middle module or QHPV have • Integrated Steritest Symbio System
Performing sterility testing using soft- to perform membrane filtration sterility
walled isolators since 1997, the Micro been qualified using biological indica-
tors. Aeration data was acquired to con- testing
Team chose the Qube because it en-
ables greater efficiency, productivity and firm VHP levels inside the isolator were • Glove Leak Tester which integrates
increased throughput. The team plans acceptable. Studies were performed to with the system to ensure glove integrity
to purchase an additional Qube System ensure there is no ingress of hydrogen
peroxide into representative sample con- • Ability to purchase software to operate
in 2021. and control environmental monitoring of
tainers at a level that could lead to false
The Qube is a modular system that is negative sterility tests. the system
configurable and allows for individual The improved efficiency obtained from
customization as it can be purchased Features of The Qube:
using the Qube System will allow the Mi-
as a 2-, 4- or 6-glove unit. The system • Provides a GradeA/ISO 5 environment cro Team to perform and report sterility
at Lancaster is made up of the follow- • Uses 35% hydrogen peroxide to test data to clients within their expected
ing main modules: two Qube Extension produce Vaporized Hydrogen Peroxide timeframe.
Modules (QEXT), two Qube Material (VHP) for surface decontamination
Transfer Devices (QMTD) and one Qube For information about sterility testing or
Hydrogen Peroxide Vapor Module • Construction allows for quick installation the Qube System, please contact your
Project Manager.
Bio/Pharmaceutical NEWS 3 Spring 2021
residuals testing, where assay
sensitivity is of great impor-
tance. The better tolerance of
ddPCR to inhibitors allows test-
ing of samples without extrac-
tion, therefore greatly reducing
the necessary volume of the
drug substance and/or drug
product allotted for testing. In
the case of viral vector product
testing, this can result in better
preservation of products that
are often produced in much
smaller batch sizes compared to
traditional biologics.
With the advantages discussed
above, ddPCR has gained rapid
momentum in QC testing labo-
ratories. Eurofins in Lancaster
has installed and validated the
BioRad QX-200 ddPCR system
within our molecular biology
laboratories. We have success-
fully performed method devel-
opment, transfer and validation
projects, and a majority of them
supporting viral gene therapy products.
ddPCR in GMP product testing In addition to customized methods for
individual clients, we are also develop-
quantifies without calibration curve & ing generic ddPCR methods targeting
consensus sequences within various
determines absolute DNA concentration viral vector backbones, to support test-
ing, including viral genome and infec-
tious titer determination. Our in-house
Weihong Wang, Manager, BioPharma Compared to quantitative real-time PCR
method validation, in conjunction with a
Biologics (qPCR), which has become a standard
product specific qualification, will allow
methodology in most molecular biology
In recent years, the number of biophar- quick implementation of GMP testing of
laboratories, ddPCR has several advan-
maceutical products incorporating nu- many sample types.
tages, especially in a GMP QC testing
cleic acids has been steadily increasing
environment. First and foremost, sam-
in the drug development pipeline. Some
of these have made it to the market in
a very visible manner such as COVID
ples can be quantified without the need
for a calibration curve. In qPCR meth- Check out EBPT’s
vaccines that deliver messenger RNA
to encode for spike protein and gene
ods, a calibration curve is typically pre-
pared from a DNA reference standard, latest LinkedIn posts
and used to interpolate sample results.
therapies for the unmet needs of those
Therefore, the quality and concentration
with rare genetic disorders. Character-
assignment of this reference standard
ization of the purity, efficacy and safety
can greatly influence the accuracy and
of these products is highly dependent
even the validity of the reported sample
on a technique known as Polymerase
results. ddPCR however, determines
Chain Reaction (PCR). A relatively new
absolute DNA concentration through
technique for the detection and quanti-
the power of statistics, thanks to the
fication of nucleic acid is digital droplet
Polymerase Chain Reaction (ddPCR). In
creation of tens of thousands of droplets Visit our LinkedIn page, which
that allow the generation of large num- focuses on all four of the US Eu-
this technique, the PCR mix containing
bers of data points from each sample. rofins BioPharma Product Testing
the test sample is partitioned into a large
This is particularly welcomed when a locations, including Lancaster, PA;
number of water-oil emulsion droplets,
well characterized reference standard Portage, MI; Columbia, MO; and San
and PCR amplification of the target DNA
truly representative of the test sample
sequence occurs in each individual Diego, CA.
is not possible, such as in the case of
droplet. Following PCR amplification,
viral vector genome copy determination. We invite you to follow this new page
each droplet is assessed to determine
the fraction of positive droplets in the
Another advantage of ddPCR is that it and engage with meaningful content
is generally considered less susceptible to help gain awareness of our ca-
sample. These data are analyzed using
than qPCR to PCR inhibitors that may pabilities. See the latest news here:
Poisson statistics to determine the target
be present in samples. This feature is www.linkedin.com/company/eurofins-
DNA template concentration in the
especially important in the context of biopharma-product-testing-usa
original sample.
Bio/Pharmaceutical NEWS 4 Spring 2021
Eurofins BioPharma Product Testing brings a wealth
of cGMP experience testing RNA based drugs
Jon Kauffman, Ph.D.,
Vice President Biolog-
ics; Michael J. McDowell,
Executive Vice President,
Eurofins BioPharma Prod-
uct Testing
In December 2020, the
Food and Drug Administra-
tion granted emergency
authorization to the Pfizer/
BioNTech and Moderna
coronavirus vaccines. This
historic research sprint
has reduced the typical
seven-year vaccine de-
velopment process to an
unprecedented 10 months.
As the initial winners in
the coronavirus vaccine de-
velopment race, the Pfizer
and Moderna vaccines have
one thing in common, they
are both mRNA based,
resulting in a new focus
on RNA drug development
technology.
Messenger RNA (mRNA)
is a type of oligonucleotide that is decade. Some of the methods em- their complexity. Therefore, additional
critical to the translation of genetic ployed include: analytical methodologies are employed
sequence information of DNA into • Characterisation of Exons (5’ Cap) to characterize the lipid and drug prod-
proteins manufactured in the cell. In and Poly (A) Tails (3’End) by Or- uct, including, % RNA encapsulation
the case of these new vaccines, this thoginal Mass Spec by Ribogreen, Lipids by HPLC-CAD,
protein is the signature spike protein Particle Size and Dispersity by Light
of the coronavirus. These mRNA • Purity/Impurity of Starting Materials Scattering.
products are considered to be their by LC/MS
As with any biopharmaceutical prod-
own unique modality. Distinct from • Purity/Impurity by Ion Exchange uct, various other characteristics are
traditional small molecule drugs and RP-HPLC and CE typically required to support stability
biologics such as monoclonal anti-
• Identity by Reverse Transcription and release testing as described in
bodies, they have their own unique USP/EP, including pH, osmolality, ap-
(RT) Sanger Sequencing
analytical challenges. At Eurofins pearance, particulate matter, sterility,
BioPharma Product Testing, support- • Total RNA by Spectroscopy bacterial endotoxin, and bioburden.
ing RNA based drug development • Potency - Cell Based Bioassays
candidates is nothing new. Eurofins’ Finally, drug developers are constantly
laboratories in Lancaster, PA; San • Residual Solvents and Metals by GC employing novel delivery systems and
Diego, CA; and Dungarvan, IRE, have and ICP formulations to increase the efficacy
supported both mRNA and RNAi • Residual plasmid DNA by PCR of their products, so additional assays
development candidates from lead- may be required to provide informa-
The approved vaccines are carried into tion to cover these aspects of the final
ing innovators with their broad cGMP the body by lipid nanoparticles with
testing service portfolio for close to a product. Contact us to learn more:
polyethylene glycol (PEG), adding to www.eurofins.com/BPT-Contact-Us.
Bio/Pharmaceutical NEWS 5 Spring 2021
Eurofins Medical
Device Testing helps
ensure Sterile Barrier
System integrity for
patient safety
Sunny J. Modi, Ph.D., Director of
Package Testing, Eurofins Medical
Device Testing
Medical device and pharmaceutical
companies across the globe are keenly
focused on developing their product
and often miss the critical require-
ments for creating a safe packaging
system that will protect the product
Sterile Barrier System (SBS) should manufacturing of the product. For
during manufacturing, transport, and
be evaluated not only at final design more information visit: www.Eurofins.
storage. One of the areas that should
stage but also during the continuous com/Medical-Device
be evaluated is how the sterile barrier
is maintained to protect the patient
and prevent the transmission of
diseases from the manufacturing line
to the surgical suite. The regulatory
Regulators enforce ISO 18562
agencies across the globe recognize Andrew Blakinger, Manager, Extract- (VOCs) emitted from the gas pathway. As
the critical nature of a Sterile Bar- ables & Leachables Testing, Eurofins air passes through the device, the VOCs
rier System (SBS) by considering it Medical Device Testing are collected on a thermal desorption
a component of a medical device or tube. These VOCs are then analyzed by
All medical devices must be assessed for
pharmaceutical product. One key gas chromatography mass spectrometry
biocompatibility. Medical devices contain-
function of an SBS is to maintain the (GC/MS) to identify and quantify them.
ing breathing gas pathways (e.g., ventila-
safety of terminally sterilized products
tors, breathing tubes, and anesthesia Leachables in condensate are the final
until the point of use in a healthcare
equipment) have traditionally been evalu- hazard. During usage, water condenses
setting. The sterile integrity of the
ated as external communicating devices inside the gas pathway. Compounds may
final packaging design can be evalu-
according to the ISO 10993 series of in- then leach from the medical device into
ated through a series of seal integrity
ternational standards. Unfortunately, this the condensate. Per ISO 18562-4, an
and seal strength testing outlined in
approach leads to testing that provides aqueous extraction is first performed. In-
ISO 11607 - Packaging for Terminally
questionable benefits and may result in ductively coupled plasma optical emission
Sterilized Medical Devices.
hazards being missed. Therefore, a new spectroscopy (ICP-OES), direct injection
Seal integrity testing identifies any set of standards – ISO 18562 – was GC/MS, and liquid chromatography mass
leaks for the area around the perime- released in March 2017 and is now spectrometry (LC/MS) are used to identify
ter of your packaging system. Some of starting to be enforced by regulators. the leachables. Identification of these
the commonly used standards for seal This four-part series is specifically geared compounds is needed for a toxicologist to
integrity are ASTMs F1886, F2096, towards the biocompatibility evaluation provide an accurate safety assessment.
F1929, and others. Seal integrity of breathing gas pathways in healthcare To identify the leachables, our scientists
testing is followed by seal strength applications. ISO 18562-1 outlines the use the Eurofins Extractables Index,
testing to evaluate the mechanical overall risk management process for the our proprietary database of over 1500
strength of your packaging system and biocompatibility evaluation, while parts two compounds, in conjunction with the Wiley/
the force needed to separate and open through four each address a specific type NIST databases.
the seal. ASTMs F88 and F1140 are of hazard. Complete understanding of the require-
commonly used standards to measure
To support our clients, we now offer the ments of ISO-18562 – including regulatory
strength of the seal. A high force nu-
full spectrum of testing required by the expectations – is important in order to
merical value could indicate challeng-
ISO 18562 series of standards to assess save valuable resources when working to
es in opening your packaging system
these three hazards. The first hazard is get a medical device to market. Having
by hand. A low force numerical value
the emission of particulate matter. To successfully performed ISO 18562 for
could indicate poor bonding of materi-
evaluate this hazard, a particle counter is over a dozen medical devices, many of
als, which would result in a breach
used to detect any particles in gas passing which have already received regulatory
of sterile integrity. As Medical device
through the device. approval, the analytical scientists and toxi-
and pharmaceutical companies con-
ISO 18562-3 addresses the second cologists here at Eurofins are in a unique
tinue to innovate across the globe, the
hazard, that of volatile organic compounds position to help medical device companies
meet this testing requirement.
Bio/Pharmaceutical NEWS 6 Spring 2021
People Are our Chemistry
At Eurofins Bio- You’ve been here
Pharma Product for many years
Testing, we and seen count-
believe that our less changes. Is
people provide there anything that
our strength. Their hasn’t changed
dedication to qual- during your ten-
ity, professional ure?
competence and In the 26 years at
hard work are the Eurofins BioPhar-
key elements in ma Product Testing
the company’s in Lancaster, PA,
success. In this the constant has
regular feature, been the focus on
we introduce you quality and ethics.
to some of the
people who have
helped make Eu- How does your
rofins an industry group’s work
leader. impact/benefit
society?
As a Research Our work contrib-
Fellow for Euro- utes to the safety
fins’ Extractables of pharmaceuti-
& Leachables cal products and
Team, Michelle medical devices.
Kolodziejski brings Everything from
Michelle and her son, Zach, hike
36 years of analytical expertise to over-the-counter medications to vac-
safeguarding clients’ biopharmaceuti- on the horseshoe trail behind their cines are evaluated to ensure that they
cal products from potentially harmful house. are safe.
impurities and unknown compounds
migrating from pharmaceutical con- What is the scope of your group?
tainer closure systems, medical and And when you’re not working?
delivery devices, and manufacturing The extractables/leachables group per- When I am not working, I enjoy audio-
components. forms testing to evaluate potential con- books, Celtic music, hiking, canoeing,
taminants that may be introduced into and travel. My favorite trips have been
To remain compliant, deliver best-in- pharmaceutical products from direct or
class service to clients, and ensure to Scotland and Iceland. Next year,
indirect contact with polymeric materials my husband and I are planning a cross
patients receive safe pharmaceuticals, during storage or production. Medical
Michelle continually investigates new Canada trip to Alaska, assuming it is
device testing for potential extractable or open.
techniques for ever-changing ISO leachable compounds is also performed.
regulations. “My team is awesome,” This includes mass spectrometry
says Michelle. “There’s great collabora- analyses for volatile, semi-volatile, non-
tion when it’s time to solve a problem volatile compounds, and ICP analysis for
and help a client identify and quantify multiple elements.
product adulteration.”
When Michelle isn’t uncovering potential Contact us
toxins in drugs or biological products, What process improvements does your
group initiate to serve clients better? For information on services, litera-
she and her husband love to go camp- ture requests or address changes,
ing, hiking and canoeing near their We are always striving to provide lower please contact: Bio/Pharmaceutical
home in the PA State gamelands. Read detection limits, widen our scope of test- Business Development, 717-656-
more about Michelle: ing, and develop our analysts to improve 2300, pha@eurofinsus.com, or visit
What does your current job entail? skills in interpretation. www.eurofinsus.com/bpt
As a Research Fellow in the Extract- Bio/Pharmaceutical NEWS is pub-
ables/Leachables Group, my job in- Why should clients trust us with their lished for clients, employees and as-
cludes leachables method development projects? sociates of Eurofins BioPharma Product
and validations, peak identification Testing US. Editor: Lisa Bamford,
investigations, and routine extractables Eurofins E/L team has been performing LisaBamford@EurofinsUS.com
testing. New techniques, such as ISO extractables/leachables testing for nearly
18562 Part 4 gas pathways process two decades. Our team includes highly
development are also part of my role. skilled analysts.
Bio/Pharmaceutical NEWS 7 Spring 2021
Lancaster Laboratories Presorted
2425 New Holland Pike Standard
Lancaster, PA 17601 RETURN SERVICE REQUESTED
U.S. Postage
PAID
Lancaster, PA
Permit No. 87
Standing together with our clients,
and the global healthcare community,
we are proud to be working nonstop
to provide testing support for virtually
every FDA approved COVID-19 vaccine
and therapy available to patients today.
In the race to eradicate this pandemic,
we are humbled by the trust that our
clients place in us to support their es-
sential therapies, including messenger
RNA, gene therapy, inactivated virus,
and protein-based vaccines, as well
as antibody cocktail therapeutics. Our
gratitude goes to our clients for choos-
ing us to be part of these groundbreak-
ing solutions that are making the world
healthier and safer.
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