NRC Biomanufacturing Vaccine Facility (BVF) Project: Overview & Status September 25, 2020 Maria Aubrey, VP And Special Advisor to the President Working Draft
NRC Biomanufacturing
Vaccine Facility (BVF)
Project:
Overview & StatusSeptember 25, 2020
Maria Aubrey, VP And Special Advisor to the President
Working Draft
CONTEXT
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• Covid-19 Pandemic
• Vaccine Task Force
• NRC Covid-19 Vaccine
Mandate
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The COVID-19 Pandemic
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Recognizing the urgent need for Canada to be able to guarantee access
for all Canadians to a safe and effective COVID-19 vaccine, when one
becomes available
The federal government developed a three-pronged strategy
to address the crisis:
Scale-Up
Partner
InvestInvest in a small number of the most promising domestic
vaccine candidates
Partner with the most promising global vaccine candidates through
advance purchase agreements and in-licensing arrangements
Scale-up domestic manufacturing capacity
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MANUFACTURE
RESEARCH
ACCESS
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[REDACTED]
NRC’s COVID-19 Vaccine Mandate
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• Ensure that facility complies with good
manufacturing practices (GMP) for
development, testing, scale-up and
production of promising vaccine
candidates
• Enable GMP certified vaccine
production capacity to produce
approx. two million doses per
month by next year.
• Establish a new biomanufacturing
facility at the Royalmount site
operated through a public-private
partnership.
• Enable the preliminary production
of 250,000 doses of vaccine per
month starting in November 2020.
Clinical Trial Manufacturing Facility (CTMF)
(Spring 2020): $44M for producing vaccines for
clinical trials
Biomanufacturing Vaccine Facility (BVF)
(Summer 2020): $126M over two years for
vaccine biomanufacturing
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BVF & CTMF:
What they are
and are not…
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Scope of the BVF & CTMF
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• Bulk commercial production – selling products
• Competing with the private sector
• Outside of pandemic response – producing traditional flu
vaccines
What the Facilities do
• Research and Development facility
• R&D bench scale to Phase I and Phase II
• Non-validated processes/ methods validated to Phase II
• Up to 500L throughput capacity
• Fill/ Finish outsourced
• Pandemic response clinical production – up to Phase II
trial
• Post-pandemic clinical production – up to first human
trials
• Training – graduate students
• Collaboration with industry, SMEs and academia
CTMFBVF
• A End-to-End GMP Manufacturing facility
• Up to 2500L throughput capacity (1 x 500L, 1 x 2000L) and approx.
4000L production capacity per/mth
• Fill/Finish included
• Pandemic response GMP production - (Phase III) / national/
international public good role – potential co-development with other
countries
• Post-pandemic GMP production – Phase II onward/ national/
international projects for rare diseases (public good)
• Training – focused on enhancing GMP expertise in Canada
• De-risk biomanufacturing capacity in Canada; work collaboratively
with industry, SMEs and academia
• Public interest funded projects (e.g., rare diseases)
What the Facilities do not do
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Continuum between CTMF, BVF & Ecosystem
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Vaccine development and
early clinical trial material
(up to 500L scale)
PROOF OF CONCEPT
Small & large-scale
production of vaccines
(500L & 2000L scales),
insuring scalability and
process maturation up to
distribution or Tech transfer
PROOF OF PRODUCT
BVF
COLLABORATIVE APPROACH - DEGREE OF OVERLAP MAY VARY
C O N T I N U U M
KEY MILESTONES = SOCIO - PHARMACO - ECONOMIC VALUE
CTMF
Biomanufacturing
Services and Bulk
commercial production of
vaccines and other
biologics
PRODUCT
COMMERCIALIZATION
CMO/CDMO eco-system
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BVF
PROJECT
OVERVIEW
& STATUS
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• Objectives
• Design & Build
• Governance
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BVF Project Objectives
1. Establish a GMP Biomanufacturing Vaccine Facility with capacity to produce approx. 2M doses* per month to
help mitigate the lack of domestic access and surety of supply for COVID-19 vaccines, including the
international community.
2. Support a pipeline of “made in Canada” vaccines and biologics, and help accelerate Canadian innovation.
This Project helps address both the immediate COVID-19 crisis and the enduring need to bolster Canada’s
biomanufacturing capacity to better position the country now and for the future.
Goals
ADDRESS LACK OF DOMESTIC
BIOMANUFACTURING
CAPACITY
HELP OUR COLLABORATORS GET
PRODUCTS APPROVED FOR
EMERGENCY AND GENERAL USE
IN CANADA
CollaborateDe-Risk
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* Number of doses produced can vary dramatically depending on the specific vaccine and the manufacturing platform, as well as the complexity of the manufacturing process.
INCREASE • the number of vaccine candidates that are brought to clinical trial and market
• the number of health innovation companies in Canada
• the amount of manufacturing undertaken by these companies
• the number of professional, science and technology-related jobs
• firm expenditure on research and development
• Strengthen Canada’s domestic capacity to manufacture, fill and
disseminate a COVID-19 vaccine
• Improve Canadians’ access to a COVID-19 vaccine and potentially
reduce the cost of accessing vaccine(s)
• Strengthen Canada’s ability to respond to the current global
pandemic and other future public health crises
STRENGTHEN
Results/ Benefits to be Realized
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BVF DESIGN
& BUILD
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• Location
• Design
• GMP process
• Critical Milestones
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Project Location at Royalmount
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NRC
Additional
Parking
BVF
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Facility Design
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• Facility production capacity 4000L/month
• Dosage dependant on vaccine (current est.
2M/month)
• ~ 4,900 m2 (on 2 floors)
• Biomanufacturing:
• USP (500L +2000L lines)
• DSP (2 dedicated lines)
• Fill & Finish (10ml multi-doses & 2ml single
doses)
• Prefab panels, Grade C and D
• Multi-products capabilities (airlocks)
• BSL2 rooms (virus sees, subculture, USP,
DSp, Fill)
• Support:
• Decontamination
• Cleaning & Sterilization
• Secondary packaging
• Warehouse
• Visitor center
• QC labs + Mechanical Area + Offices on the second
floor
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Process Overview (Aug 8, 2020)
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Interior
Design
complete
November
2020
Shell
Construction
complete
Dec 2020
Interior fit-up
March 2020
QA and QC for
Facility
Commissioning
Starts May
2021
Facility
Commissioned &
Qualified
July 2021Procurement
of long-lead
equipment
Sept 2020
Design and
build
launched
August 2020
Facility Design and Build: Mission Critical Milestones
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Construction is Underway
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BVF
GOVERNANCE
& RISKS
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03
02
04
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Key Risks to Manage
There is a risk that the
vaccine candidate to
respond to the COVID-19
pandemic may be
delayed, impacting the
facility’s readiness due to
the time required for
technology transfer and
regulatory approval prior
to GMP vaccine
production.
Mitigation: Get the
facility operationally ready
based on generic GMP
vaccine process, and
adjust once vaccine is
received.
Delay in
COVID-19
Vaccine
Candidate
Operational
readiness
delays
There is a risk that we
won’t be able to
acquire the resources
needed to get the
facility operationally
ready.
Mitigation: Expedite
purchase of long lead
equipment and on
boarding of
experts/qualified
personnel immediately.
Regulatory and
commissioning
delays
There is a risk that the
time it takes to validate
the new facility and
receive regulatory
approval/testing will
cause delays.
Mitigation: Involve
Health Canada
regulators in each step
to provide them
transparency and
shorten turnaround.
Long-Term
Sustainability
There is a risk that we
create short-term
capacity to respond to
COVID-19 that lies
dormant in the future.
Mitigation: Develop
BVF sustainability
business case based
on market assessment
and financial modelling
scenarios (opex costs
& pricing).
There is a risk that
facility’s physical build
will be delayed.
Mitigation: This
strategy leverages
existing buildings and
infrastructure in order
to minimize the risk of
new builds.
Construction
delay
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NRC President
VP & Special Advisor to the
President
Guidance & Oversight
BVF Project Advisory Board
BVF Project Steering
Committee
Senior Project Manager
BVF Delivery
Design
Construction
Procurement
Qualification
Director General BVF Operations
Director GeneralBVF Project
PM&A Office
Project Management & Administration
Policy Analysis
Business Strategy
Project Governance &
Structure
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Independent
Third Party
Review
External
Advisors
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Annex A: Other
Biomanufacturing
Facilities abroad
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VMIC: Operational Governance
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Board Composition:
• [REDACTED]
• 3 academic institutions; University of Oxford, Imperial College
and the London School of Hygiene and Tropical Medicine
• 3 industrial partners; Janssen, MSD and Cytiva, formerly GE
Life Sciences who contribute in-kind industry funding
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VMIC: Management Governance
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UK Government present as an observer only and level of involvement is
establish in the partnership agreement:
• VMIC will serve as an emergency response capability for the UK
government in order to produce vaccines against emerging infectious
diseases and deliberate/accidental release of biological agents
[REDACTED]
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CIADMs (USA): Overview
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• U.S. Department of Health and Human Services (HHS) issued RFPs for CIADMs as public‐private
partnerships
• Centers for Innovation and Advanced Development Manufacturing’s (CIADM) formed part of a national
strategy to increase domestic vaccine and other biologicals manufacturing capabilities in an emergency
• CIADMs run by a consortium led by an organization experienced in developing or manufacturing
medical countermeasures
• HHS awarded 3 contracts;
• Emergent Manufacturing Operations Baltimore LLC, Baltimore, Md
• Seqirus, Holly Springs, NC (originally operated by Novartis )
• Texas A&M University System of College Station, Texas
• HHS supports cost of operation and maintenance in subsequent years
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CIADMs: Operational Governance
• CIADM’s formed part of a national strategy to;
• Addressing capacity to respond to pandemics and bioterrorism threats, and increase domestic
vaccine and other biologicals manufacturing capabilities in an emergency
• Support development and manufacturing of chemical, biological, radiological and nuclear
medical countermeasures
• Advance and promote the biotech workforce by providing workforce development programs
• CIADMs run by a consortium led by an organization experienced in developing or manufacturing
medical countermeasures
• Overseen by BARDA (Biomedical Advanced Research and Development Authority) within the HHS
office
• Contracts can be renewed for up to 25 yrs representing long-term commitment to partnership with
industry and national security
• HHS supports cost of operation and maintenance in subsequent years27
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thank you
Maria Aubrey, VP And Special Advisor to the President