Vaccine Development and Manufacture – an Overview 1
Disclosure Statement 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. biotech.ca
Objectives 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 biotech.ca
Uniquely for Vaccines, THE PRODUCT IS THE PROCESS 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) biotech.ca
New Vaccine Development Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century biotech.ca
Canadian Vaccine R&D and Manufacturing Sites biotech.ca BIOTECanada’s Vaccine Industry Committee 6
Clinical Trials • In order to register your product with Health Canada, you need appropriate clinical trials • They should show your product is safe and effective biotech.ca
Clinical Trial Application • 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 biotech.ca
New Drug Submission • 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 biotech.ca BIOTECanada’s Vaccine Industry Committee
VACCINES: A COMPLEX MANUFACTURING PROCESS A complex vaccine: biotech.ca BIOTECanada’s Vaccine Industry Committee 10
biotech.ca Antigen Production
Cell Culture Monitored for: Temperature • pH • Oxygen rate • Sterility • Homogeneity • biotech.ca
Isolation and Purification of the Antigens Advances in Purification Technologies Accelerate Vaccine Development biotech.ca
biotech.ca Formulation
Filling • Filled into vials or syringes • Vials can be liquid or biotech.ca freeze ‐ dried 15
Inspection biotech.ca
Labelling and Packaging biotech.ca BIOTECanada’s Vaccine Industry Committee 17
Revisiting the manufacturing overview A complex vaccine may : biotech.ca BIOTECanada’s Vaccine Industry Committee 18
Testing – Throughout the process Continuous testing biotech.ca
On average, 4 years for worldwide approval of a post-approval change biotech.ca
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 • biotech.ca
Questions? biotech.ca
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