BIOLOGICS MANUFACTURING CENTRE ANNOUNCEMENT - Media Kit June 22, 2021 - National Research Council ...
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BIOLOGICS MANUFACTURING CENTRE ANNOUNCEMENT Media Kit · June 22, 2021
CONTENTS 1. Biologics Manufacturing Centre overview 2. Biologics Manufacturing Centre milestones 3. Biologics Manufacturing Centre vaccine production 4. Biologics Manufacturing Centre and Novavax 5. Clinical Trial Material Facility overview 6. Biologics Manufacturing Centre and Clinical Trial Material Facility key facts
BIOLOGICS MANUFACTURING
CENTRE OVERVIEW
The National Research Council This accelerated process allowed for a
of Canada was mandated by condensed construction schedule, while still
the Government of Canada addressing all of the many details required to
to establish the new Biologics ensure the facility meets GMP compliance.
Manufacturing Centre at Next steps
our Royalmount site in
Although construction and interior fit-up of the
Montréal, Quebec.
Biologics Manufacturing Centre are now both
PURPOSE complete, several critical steps remain before
The Biologics Manufacturing actual vaccine production can begin.
Centre will: Each of these steps must be customized for the
∙ Ensure access to domestic specific vaccine that will be produced:
production capacity for vaccines ∙ Technology transfer – to establish the process
and other biologic products in times of making the specific vaccine in the facility
of national and global emergencies ∙ Process qualification – to ensure the process
∙ Advance development of the industry will produce the specific vaccine with precisely
in Canada by supporting made-in-Canada the same quality in every dose
vaccines and help accelerate Canadian ∙ Health Canada approval – regulatory checks
innovation to ensure the specific vaccine, produced with
the specific process, in the specific facility will
CONSTRUCTION AND FIT-UP COMPLETE result in precisely the same quality in every dose
Generally, a new Good Manufacturing Practices
(GMP)-compliant biomanufacturing facility can These customized processes and approvals are
take two years or more to complete. an essential part of ensuring the vaccines being
produced are consistently safe and effective for
The construction and interior fit-up of the
Canadians to use.
Biologics Manufacturing Centre was completed
after just 10 months. This is one month ahead KEY FEATURES
of schedule. ∙ Full end-to-end manufacturing capabilities
Accelerated process - from scale-up to secondary packaging
Hiring multiple teams of contractors enabled ∙ Flexible physical configuration
consecutive work shifts. ∙ Two individual production lines
The interior fit-up design of the Biologics ∙ GMP-compliant
Manufacturing Centre was completed while
the construction of the building shell was
taking place.
Facility characteristics Based on 500 doses per litre, this would translate
∙ Approximately 5,400 square metres/ into approximately 24 million doses of a vaccine
58,000 square feet per year.
∙ Critical heat, ventilation and air The number of doses will vary widely depending
conditioning (HVAC) systems on the specific vaccine and its manufacturing yield.
∙ Critical purified water and water for
GOOD MANUFACTURING PRACTICES (GMP)
injection (WFI) systems
GMP compliance has been an integral part
∙ Large quality control laboratory space of the Biologics Manufacturing Centre design
∙ Cold room storage from the beginning.
∙ Large warehouse area GMP regulations ensure that drugs meet
the quality standards appropriate to their
Specialized equipment includes
intended use.
∙ Bioreactors: 50L, 200L, 500L, 2000L
GMP compliance requires that the people,
∙ Chromatography and tangential filtration
premises, processes, products, and procedures
equipment involved in making a vaccine are doing exactly
∙ Aseptic filling equipment what they are supposed to do with repeatable
FINANCIAL precision.
Government of Canada investment With an end product intended to be administered
∙ $126 million to build the facility to people, absolute compliance GMP is required
to ensure vaccines produced in the facility are
∙ $20 million per year to cover operating costs
consistent in safety, identity, strength, purity, and
Status: On budget quality — every single dose, every single time.
HUMAN RESOURCES To ensure compliance with GMP regulations, the
Full-time positions expected: 100 Health Product Compliance Directorate (HPCD)
of Health Canada inspects establishments that
Full-time positions filled to date: 60 fabricate, package or label, distribute, import,
Expertise in: Good Manufacturing Practices, wholesale or test drugs. During these inspections,
biopharmaceutical/vaccine, cell culture and HPCD verifies GMP compliance with Part C,
purification, quality assurance, quality control, Division 2 of the Food and Drug Regulations.
manufacturing, supply chain/warehouse, This is a requirement for issuing a drug establish-
facilities/engineering, manufacturing science, ment licence and to ensure products are safe for
regulatory affairs, and more. human use.
TYPE OF PRODUCTS More information on GMP can be found on
The Biologics Manufacturing Centre will be the Health Canada website.
able to produce cell-based biopharmaceuticals
like vaccines and other biologics, including CONTACT
viral vector, protein subunit, virus-like particles, Media Relations
and other recombinant proteins. NRC.MediaRelations-RelationsMedias.CNRC@
nrc-cnrc.gc.ca
PRODUCTION CAPACITY
© 2020 Her Majesty the Queen in Right of Canada, as represented by the
The Biologics Manufacturing Centre will National Research Council of Canada. 06·2020 · Également disponible en français
have a production capacity of approximately
4000 litres a month.
BIOLOGICS MANUFACTURING
CENTRE MILESTONES
The construction and interior fit-up of FEBRUARY 2021
the new Biologics Manufacturing The Government of Canada signed a
Centre on the National Research memorandum of understanding in February
Council of Canada’s (NRC) to pursue options to produce Novavax, Inc.’s
Royalmount site in Montréal COVID-19 vaccine candidate in the Biologics
is now complete, less than Manufacturing Centre. In March, the NRC
one year after breaking signed a collaboration agreement with Novavax
ground, and one month to enable the related technology transfer to
ahead of schedule. This begin in early April.
and other critical mile-
stones are outlined below. APRIL 2021
The technology transfer is a critical step before
AUGUST 2020 a product can be manufactured in the Biologics
Design and construction of Manufacturing Centre. It must be customized
the Biologics Manufacturing for each specific product that is produced in
Centre began. the facility.
An accelerated pace allowed the The technology transfer establishes the step-
NRC to significantly condense the by-step process of making a specific vaccine in
schedule, while still addressing all of the the facility, including identifying the product-
many details required to ensure the facility is specific materials and equipment to be used
Good Manufacturing Practices (GMP) compliant. within the facility.
DECEMBER 2020 These details are methodically outlined,
tested and documented multiple times, to
The exterior shell of the Biologics Manufacturing
ensure the process will consistently produce
Centre was completed, less than six months after
the intended product.
breaking ground.
In parallel with the technology transfer process,
Completing this milestone on schedule allowed
a manufacturing agreement will be established
the interior construction to take place and
between the Biologics Manufacturing Centre
the fit-up to start during the remaining winter
and the vaccine sponsor before full-scale
months, and the overall condensed construction
vaccine production can take place.
schedule to be maintained.
The interior fit-up began, with long-lead equip-
ment ordered and beginning to arrive on site.
August December April June August September December
2020 2020 2021 2021 2021 2021 2021
Exterior shell Construction and Start Process
completed and interior fit-up engineering runs qualification
interior fit-up completed and drug
started production
Design and Vaccine candidate Complete commissioning Complete
construction collaboration agreement and submit drug engineering runs
started signed and technology establishment licence
transfer initiated
Completed milestones
JUNE 2021 These test runs confirm that the full-scale process
The construction and all interior fit-up for the will produce the vaccine in accordance with the
Biologics Manufacturing Centre was completed required specifications and quality characteristics
in only 10 months, which is one month ahead as defined by the vaccine sponsor.
of schedule. Generally, a GMP-compliant EARLY 2022
biomanufacturing facility can take two years
or more to complete. Process qualification is expected to be complete
This includes the exterior and interior construction, The Biologics Manufacturing Centre will
and the receipt and installation of equipment to produce process qualification batches, which
be ready for commissioning, and GMP qualifica- demonstrate consistent and reliable production
tion and validation. of the vaccine using the established process
under GMP conditions.
Preparation is in progress for the following
critical milestones in the commissioning, These batches will be tested extensively to
qualification and initial operations of the ensure the process has resulted in precisely
Biologics Manufacturing Centre. the same quality in every batch and can be
approved by Health Canada for human use.
AUGUST 2021 The results of these batches, with the supporting
Commissioning is expected to be complete. analysis and documentation, will then be
The commissioning of a facility, equipment, submitted by the vaccine sponsor for regulatory
or system for operation under GMP regulations approval by Health Canada.
involves qualification (the process of determining These necessary quality assurance processes
that all operations, including the facility, utilities, and regulatory approvals ensure vaccines
systems and equipment, are suited for their produced in Canada are consistently safe
intended purpose). For this facility, that purpose and effective for human use. They are complex
is the production of vaccines for human use. and can take several months to complete.
Application for drug establishment licence The timing for the release and distribution of
is expected to be complete. the vaccine is dependent on when the vaccine
Once the commissioning is complete, the sponsor receives regulatory approval.
Biologics Manufacturing Centre will apply
for a drug establishment licence from Health CONTACT
Canada. As a Canadian drug production Media Relations
facility, this licence is required to demonstrate NRC.MediaRelations-RelationsMedias.CNRC@
compliance with Good Manufacturing Practices. nrc-cnrc.gc.ca
DECEMBER 2021 media@novavax.com
Engineering runs are expected to be complete. © 2020 Her Majesty the Queen in Right of Canada, as represented by the
National Research Council of Canada. 06·2020 · Également disponible en français
Engineering runs are used to demonstrate
full-scale manufacturing in the environment
under which the vaccine will be produced,
including equipment and processes.
BIOLOGICS MANUFACTURING
CENTRE VACCINE PRODUCTION
The Biologics Manufacturing Centre When the desired cell density is achieved,
is designed to produce cell‑based they can be transferred into a 2,000L bioreactor
biopharmaceuticals like vaccines for final production, which is the largest in
and other biologics, including the Biologics Manufacturing Centre. It holds
viral vector, protein subunit, roughly the equivalent of 12 standard bathtubs.
and virus-like particles and It can take several weeks for the cells to fully
other recombinant proteins. expand to sufficient numbers to be ready for
HOW DO VACCINES WORK? the next step. The technical term for this cell
growth phase is up-stream processing.
The goal of a vaccine is to
introduce small, safe amounts SEPARATION AND PURIFICATION
of antigens to the body. This helps Once the cells have grown to sufficient
the immune system recognize them numbers, the cell culture is then separated,
as hostile and develop antibodies, which so that only the parts needed for the vaccine
help protect the body from future infections. are kept. Everything else is discarded.
In the case of SARS-CoV-2, the virus that At this point, the cell mixture is still complex
causes COVID-19, the antigen being used by and needs to be purified so that only the
most vaccines is called a viral spike protein. desired product — the antigen — remains.
ANTIGEN PRODUCTION One technique used to help purify the cell
To make millions of doses of a vaccine, large mixture is chromatography, a process that
quantities of the cells that produce the antigen separates the mixture into its individual
need to be grown. components, resulting in the isolation of
pure antigen. Any contaminants and
This growth is done using bioreactors, where impurities are discarded.
conditions like temperature and oxygen levels
can be tightly controlled to provide optimal The separation and purification process
conditions. takes approximately five to seven days.
This is called down-stream processing.
The cell cultures grown in bioreactors can
be scaled up to high volumes by transferring Once the down-stream processing steps
them to successively larger bioreactors. are complete, the result is the medically
active — and most important — ingredient
In the Biologics Manufacturing Centre, the of the vaccine. Called the drug substance,
cells can initially be grown in a 20L vessel this is what makes the vaccine work.
before being moved to a 200L bioreactor
for further growth.
It may be the most important part of the QUALITY ASSURANCE
vaccine, but the drug substance is not actually Compliance with Good Manufacturing
the largest ingredient. Practices (GMP) is an integral part of the
Most vaccines consist of mostly very pure water, design and operation of the Biologics
which is added as part of the formulation process Manufacturing Centre.
using a water for injection system. GMP requires that the people, premises,
processes, products, and procedures involved
in making a vaccine are doing exactly what they
are supposed to do with repeatable precision.
With an end product intended to be
administered to people, absolute compliance
is required to ensure vaccines produced in a
GMP facility are consistent in safety, identity,
strength, purity, and quality — every single
dose, every single time.
Ongoing quality assurance and quality control,
including constant testing and verification,
FORMULATION ensure this compliance, supported by solid
The formulation process is where the scientists documentation at each step in the process.
work to stabilize the drug substance and dilute GMP compliance and exhaustive quality
it to the concentration needed for final use. assurance protocols are essential to ensuring
Certain vaccines contain an adjuvant, a the products produced in the Biologics
substance that enhances the body’s immune Manufacturing Centre will be safe for human use.
response to an antigen. Added during the This high-level overview of vaccine production
formulation process, adjuvants can help make in the Biologics Manufacturing Centre is
a vaccine more effective. intended for general information purposes
Once the formulation process is complete, the only. An extensive technology transfer process
result is called the drug product. This is the from the vaccine developer will determine the
actual vaccine solution. exact methodology required for each specific
product produced in the facility.
FILL-AND-FINISH
The vaccine solution is subsequently moved CONTACT
to a fill-and-finish area, where it is distributed Media Relations
into sterile vials using specialized machinery NRC.MediaRelations-RelationsMedias.CNRC@
called aseptic filling equipment. nrc-cnrc.gc.ca
Each vial is carefully inspected, then closed, © 2020 Her Majesty the Queen in Right of Canada, as represented by the
National Research Council of Canada. 06·2020 · Également disponible en français
labelled, packaged, and put into cartons
on pallets.
The vaccine is ready to be shipped to its
next destination.
BIOLOGICS MANUFACTURING
CENTRE AND NOVAVAX
In February 2021, the Government Novavax remains focused on advancing develop
of Canada signed a memorandum of ment of NVX-CoV2373, including completion of
understanding (MOU) with Novavax, filing for regulatory authorization in Canada.
Inc. to pursue options to produce
its COVID-19 vaccine candidate PRODUCTION IN THE BIOLOGICS
at the National Research Council MANUFACTURING CENTRE
of Canada’s (NRC) Biologics February 2021 – MOU with Novavax signed
Manufacturing Centre in to pursue options to produce its COVID-19
Montréal, Québec, once both vaccine at the Biologics Manufacturing Centre.
the vaccine candidate and the March 2021 – Vaccine candidate collaboration
facility receive the required signed to enable technology transfer for
Health Canada approvals. production of the Novavax COVID-19 vaccine
in the Biologics Manufacturing Centre.
COLLABORATION AGREEMENT April to December 2021 – Technology transfer
In March, the NRC signed a collaboration initiated and will continue in the coming months
agreement with Novavax to enable tech with engineering runs targeted for fall to demon
nology transfer to begin in early April. strate full-scale manufacturing in the environment
The NRC and Novavax have been working closely under which the vaccine will be produced,
together to prepare for the production of the including the facility, equipment and processes.
Novavax vaccine at the Biologics Manufacturing Early 2022 – Once engineering runs have
Centre, including conducting the technology been successfully completed, the Biologics
transfer to establish the step-by-step process Manufacturing Centre will produce process
of making the vaccine in the NRC’s facility. qualification batches to demonstrate consistent
The related steps are being methodically and reliable production of the vaccine using the
outlined, tested and documented in line with established process under Good Manufacturing
industry practices, to ensure the process will Practices (GMP) conditions.
consistently produce the intended product. These batches will be tested extensively to
In parallel with the technology transfer process, ensure the process has resulted in precisely
a manufacturing agreement will be established the same quality in every batch, accepted by
between the Biologics Manufacturing Centre the vaccine sponsor, and can be approved
and Novavax before full-scale vaccine by Health Canada for human use.
production can begin. The results of these batches, with the supporting
analysis and documentation, will then be
NOVAVAX OVERVIEW submitted by the vaccine sponsor for regulatory
Novavax, Inc. is a biotechnology company that approval by Health Canada. This is a complex
promotes improved health globally through the process and can take several months.
discovery, development and commercialization
of innovative vaccines to prevent serious CONTACT
infectious diseases. Media Relations
Novavax is conducting late-stage clinical trials NRC.MediaRelations-RelationsMedias.CNRC@
for NVX-CoV2373 COVID-19, a protein subunit nrc-cnrc.gc.ca
based vaccine candidate against SARS-CoV-2, media@novavax.com
the virus that causes COVID-19.
© 2020 Her Majesty the Queen in Right of Canada, as represented by the
National Research Council of Canada. 06·2020 · Également disponible en français
CLINICAL TRIAL MATERIAL
FACILITY OVERVIEW
In spring 2020, the Government of ∙ Provided GMP training to researchers.
Canada invested $44 million for ∙ Hired GMP specialists such as quality
the National Research Council of assurance personnel.
Canada (NRC) to design, construct,
commission, and qualify a GMP- ∙ Wrote 150+ standard operating protocols
compliant clinical trial material related to GMP compliance and quality
facility to de-risk and accelerate assurance framework.
vaccine development at the
NRC’s Royalmount site in WINTER 2020/21
Montréal, Québec. PLANNING A PERMANENT FACILITY
As priorities shifted during the course of
SPRING - FALL 2020 the pandemic, the NRC pivoted to planning
READINESS FOR construction of a new-build permanent clinical
A TEMPORARY FACILITY trial material facility, which will be an essential
Renovation work was undertaken to long-term sustainable part of Canada’s
functionalize a temporary facility within the biomanufacturing capacity.
existing NRC building to be ready for potential This shift meant new site assessments and
production of clinical trial materials. concept designs were needed to initiate
During this time, the NRC: construction of an optimal and flexible facility
for future production of clinical trial materials.
∙ Purchased and received equipment for the
clinical trial material facility, such as 50-litre The aseptic filling equipment was moved to
and 500-litre bioreactors and aseptic a permanent location in the NRC’s Biologics
filling equipment. Manufacturing Centre.
∙ Upgraded existing facilities to prepare for Other equipment purchased for the temporary
a potential need to produce clinical trial facility such as bioreactors, will be transferred to
materials under GMP conditions. the new permanent clinical trial material facility
∙ Renovated existing larger-scale purification once construction is complete.
suites to meet enhanced biosafety guidelines.
∙ Installed aseptic filling equipment in a
temporary location.PERMANENT CLINICAL TRIAL The research and development labs, clinical trial
MATERIAL FACILITY material facility and Biologics Manufacturing
Design and engineering work is now underway Centre could operate together or separately,
for a new permanent GMP-compliant facility. depending on the requirements for each
particular project.
The new permanent clinical trial material
facility will: PROJECT MILESTONES
∙ Enable Canadian vaccines and other biologics Spring 2021 - New concept plan approved
to advance to clinical trials in Canada. and design, engineering and architecture
∙ Be a product development bridge between contracts awarded.
vaccine research and development, and Summer 2021 - Select construction management
vaccine production of late-stage or authorized firm, hire GMP consultant, continue procurement.
products in large quantities elsewhere.
Fall 2021 - Begin design and construction.
∙ Be a technology transfer hub to complete
verification runs and optimize GMP Winter 2021/22 - Complete detailed design
manufacturing processes. and exterior shell.
∙ Be an essential part of the continuum of Summer 2022 - Complete construction.
building Canada’s biomanufacturing capacity. Winter 2022/23 - Complete interior fit-up,
commissioning and qualification.
When it is complete, the new facility will
be able to produce clinical trial materials of
cell-based biologics, including viral vector,
protein subunit, virus-like particles, and other
recombinant proteins
Building on more than 30 years of experience
in biomanufacturing research and development,
the addition of the clinical trial material facility
will enable the NRC to support three distinct,
but complementary, stages of biomanufacturing
in Canada:
∙ vaccine research and development in the
existing research labs.
CONTACT
∙ GMP-compliant production of clinical trial
NRC.MediaRelations-RelationsMedias.CNRC@
material at the new clinical trial material facility.
nrc-cnrc.gc.ca
∙ GMP-compliant vaccine production at © 2020 Her Majesty the Queen in Right of Canada, as represented by the
the Biologics Manufacturing Centre. National Research Council of Canada. 06·2020 · Également disponible en françaisBIOLOGICS MANUFACTURING
CENTRE AND CLINICAL TRIAL
MATERIAL FACILITY KEY FACTS
There are two separate vaccines and biologics can be safely
construction projects manufactured in Canada in the future.
underway at the NRC’s The clinical trial material facility is intended
Royalmount site in to manufacture vaccine and other biologic
Montréal that will materials for clinical trials. The NRC is
help support Canada’s completing the final design and engineering
biomanufacturing work for this permanent GMP-compliant
production capacity. clinical trial material facility. When complete,
The Biologics this facility will support vaccine development
Manufacturing Centre at the clinical trial stage.
is a new biomanufacturing As a combined capability across the value
facility to manufacture chain of biologics research, development
vaccines and other biologics and production, the Biologics Manufacturing
for large-scale human use. Centre and the clinical trial material facility
Its first priority will be to produce will strengthen overall biomanufacturing
safe and effective COVID-19 vaccines, capacity and pandemic readiness in Canada.
therapeutics, and other biologics for
Canada. The Biologics Manufacturing Centre The table below explains further the similarities
will also ensure that large quantities of other and the differences between the two facilities.
Biologics Manufacturing Centre Clinical Trial Material Facility
Funding / $126M to design, construct, commission $44M to design, construct, commission
Purpose and qualify a new GMP-compliant and qualify a GMP-compliant permanent
end-to-end biomanufacturing facility to clinical trial material facility to de-risk
produce vaccines and other biologics and accelerate vaccine development
Location On the NRC’s Royalmount site On the NRC’s Royalmount site
in Montréal in Montréal
Planned Manufacturing vaccine and other Manufacturing vaccine and other
Operations biologics for large-scale human use biologics materials for clinical trialsBiologics Manufacturing Centre Clinical Trial Material Facility
Status Construction and interior design Equipment procured, staff training and
complete, installation of critical procedures underway, completing final
equipment underway design and engineering work
Construction Construction includes: Construction will include:
scope ∙ Physical building construction ∙ Physical building construction
∙ Interior design and fit-up ∙ Interior design and fit-up
Expected Completed June 2021 Summer 2022
completion of
construction
Technology A customized approach for technology transfer, revalidation, and product-specific
transfer Health Canada approval will be needed before actual vaccine production can begin
Vaccine type Cell-based biologics – i.e. viral vector, Cell-based biologics – i.e. viral vector,
protein subunit, virus-like particle based protein subunit, virus-like particle based
vaccine doses materials for clinical trials
Manufacturing Bioreactor capacity of approximately Bioreactor capacity of approximately
capacity 4000 litres per month 500 litres per month
Number The number of doses will vary widely depending on the type of vaccine,
of doses the manufacturing platform and process as well as its yield
Based on information of general yields available for other products, a conservative
estimate is 500 doses/L/month.
This could translate to approximately This could translate to up to 250,000
2 million vaccine doses per month doses per month of vaccine materials
for clinical trials
CONTACT
Media Relations NRC.MediaRelations-RelationsMedias.CNRC@nrc-cnrc.gc.ca
© 2020 Her Majesty the Queen in Right of Canada, as represented by the National Research Council of Canada.
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