Vaccine Development and Manufacture an Overview 1 Disclosure - - PowerPoint PPT Presentation

Vaccine Development and Manufacture – an Overview

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Vaccine Industry Committee (VIC) members of BIOTECanada are vaccine manufacturers serving the Canadian market and early stage Canadian companies developing advanced vaccines. The VIC receives funding from its member companies.

Disclosure Statement

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By the end of the seminar, participants will be able to:

• Describe how vaccines are developed by

industry and the process for submission for regulatory approval

• Describe vaccine manufacturing and quality

control processes

Objectives

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Live viruses and bacteria (antigens) Registration and adherence to entire specific process, not just product composition.

Electron microscope image of vero cells (balls of sephadex) for Inactivated Polio Vaccine production (IPV)

Uniquely for Vaccines, THE PRODUCT IS THE PROCESS

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New Vaccine Development

Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century

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6 BIOTECanada’s Vaccine Industry Committee

Canadian Vaccine R&D and Manufacturing Sites

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• In order to register your product with Health

Canada, you need appropriate clinical trials

• They should show your product is safe and

effective

Clinical Trials

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• Health Canada approval of a Clinical Trial Application

(CTA) is required to perform trials in humans

• The CTA is composed of three parts (modules):

– Module 1 ‐ administrative and clinical information about the proposed trial – Module 2 ‐ contains Quality (Chemistry and Manufacturing) information about the drug product(s) to be used in the proposed trial – Module 3 ‐ contains additional supporting Quality information

• 30‐day review time

Clinical Trial Application

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• CTD format:

– Module 1: Administrative and Product Information – Module 2: Common Technical Document (CTD) Summaries – Module 3: Quality – Module 4: Nonclinical Study Reports – Module 5: Clinical Study Reports – Submissions are filed electronically (eCTD format)

• 300‐day review time

New Drug Submission

BIOTECanada’s Vaccine Industry Committee

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VACCINES: A COMPLEX MANUFACTURING PROCESS

BIOTECanada’s Vaccine Industry Committee

A complex vaccine:

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Antigen Production

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Cell Culture

Monitored for:

• Temperature
• pH
• Oxygen rate
• Sterility
• Homogeneity

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Isolation and Purification of the Antigens

Advances in Purification Technologies Accelerate Vaccine Development

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Formulation

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Filling

• Filled into

vials or syringes

• Vials can be

liquid or freeze‐dried

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Inspection

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Labelling and Packaging

BIOTECanada’s Vaccine Industry Committee

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Revisiting the manufacturing overview

BIOTECanada’s Vaccine Industry Committee

A complex vaccine may :

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Testing – Throughout the process

Continuous testing

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On average, 4 years for worldwide approval of a post-approval change

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Vaccines – Complex in formulation, testing and maintenance

One vaccine =

• Multiple biological antigens
• Up to 50 manufacturing steps
• 200+ analytical methods
• 1200 + individual tests
• Up to 3 years to manufacture and test
• Up to 4 years to implement the change worldwide

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Questions?