nrc biomanufacturing vaccine facility (bvf) project

NRC Biomanufacturing

Vaccine Facility (BVF)

Project:

Overview & StatusSeptember 25, 2020

Maria Aubrey, VP And Special Advisor to the President

Working Draft

CONTEXT

2

• Covid-19 Pandemic

• Vaccine Task Force

• NRC Covid-19 Vaccine

Mandate

NATIONAL RESEARCH COUNCIL CANADA

The COVID-19 Pandemic

3

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


MANUFACTURE

RESEARCH

ACCESS

NATIONAL RESEARCH COUNCIL CANADA4

[REDACTED]

NRC’s COVID-19 Vaccine Mandate

5

• 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


BVF & CTMF:

What they are

and are not…

6NATIONAL RESEARCH COUNCIL CANADA

Scope of the BVF & CTMF

7

• 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


Continuum between CTMF, BVF & Ecosystem

8

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


BVF

PROJECT

OVERVIEW

& STATUS

9

• Objectives

• Design & Build

• Governance


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


* 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

NATIONAL RESEARCH COUNCIL CANADA11

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BVF DESIGN

& BUILD

12

• Location

• Design

• GMP process

• Critical Milestones


Project Location at Royalmount

13

NRC

Additional

Parking

BVF


[REDACTED]

Facility Design

14

• 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


[REDACTED]

Process Overview (Aug 8, 2020)



16

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


Construction is Underway


BVF

GOVERNANCE

& RISKS


19

03

02

04


[REDACTED]

20

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


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

21

Independent

Third Party

Review

External

Advisors


Annex A: Other

Biomanufacturing

Facilities abroad


23


[REDACTED]

VMIC: Operational Governance

24

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


VMIC: Management Governance

25

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]


CIADMs (USA): Overview

26

• 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


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


• 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


• 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


thank you

Maria Aubrey, VP And Special Advisor to the President

nrc biomanufacturing vaccine facility (bvf) project

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