Vaccine Innovation Conference Toronto, May 26, 2015 · 2016-04-06 · 1 Vaccine Innovation...
Transcript of Vaccine Innovation Conference Toronto, May 26, 2015 · 2016-04-06 · 1 Vaccine Innovation...
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Vaccine Innovation Conference
Toronto, May 26, 2015
Formulations, Delivery and Bioprocessing
Jim Richards, National Research Council of Canada
Vaccine Formulation, Delivery and Bioprocessing – a Look at the
Canadian Landscape
Adjuvants
Dose Sparing
Thermostable
Cancer
(CMI)Robust
Immunity
Immuno-compromised
Needle-free
Formulation and Delivery
New formations leading to challenges in vaccine
development and manufacture…
Modern Vaccines – with the use of novel compounds and
formulation technologies - are complex and difficult to test
Require additional scrutiny and validation which can slow
vaccine development due to significant challenges in
vaccine regulation
Formulation stability is a key consideration for vaccine
manufactures – formulations need to be tailored for use in
a cGMP environment
Vaccine Manufacturing in Canada
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GSK Vaccines
St Foy PQ
Influenza Manufacture
Sanofi Pasteur
Connaught Campus, Toronto ON
R&D and Manufacturing
Pilot facility
cGMP material for clinical trials
Manufacturing facilities
Canada (Quebec City)
USA (North Carolina)
Commercial facility
• cGMP large scale
• Pandemic, seasonal flu
Medicago – Plant Manufacturing facilities
What about the ~40 Canadian SME Product
Developers
Contract Organizations:CRO Preclinical Contract Research OrganizationsCMO Contract Manufacturing OrganizationsCTO Clinical Trial Organizations
Milestones:IND Investigational New Drug (tests in humans)NDA National Drug Application (market)
Preclinicalstudies
Toxicology
CROMicrobialcGMPproduction
MammaliancGMPproduction
CMO Liquid vials
Lyophilizing
Fill FinishRecruiting patients
Conducting tests
Data collection
CTOMarketing
Sales
Distribution
Surveillance
Market
Consultant IND
Consultant NDA
SME
What happens after development?
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Vaccines and biologics production in mammalian cells includes:
• Development of cell lines, media and components
• Pilot to production scale-up in bioreactors and fermenters
• Purification
• cGMP production scale-up for clinical useUnfortunately, production for clinical use is currently outsourced
to Contract Manufacturing Organizations (CMOs) outside Canada (mainly US), resulting in a loss of economic impacts for
Canada.
Canadian CMOs – Current Status
NRC Biomanufacturing Initiative – Fostering Strong,
Prosperous Canadian Biomanufacturing Sector
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• Transferring NRC expression systems and bioprocessing know-how to Canadian CMOs producing cGMP-quality material in mammalian cellexpression systems
CHO cells HEK293 cells
• Encouraging SME developers to select Canadian CMOs to produce their biologics and vaccines for clinical trials and market
NRC Mammalian cell pilot plant up to 500 L
Todays Session
Dr. Denis Leclerc (Folia Biotech): A novel Canadian adjuvant
and its potential in vaccine development and immunotherapy
Dr. Volker Gerdts (VIDO-InterVac): Innovations that have led to
the development of improved vaccine formulations and
delivery strategies, and which are currently being evaluated in
the preclinical stage.
Dr. S. Fernando Ausar (Sanofi Pasteur): Essential steps
required for optimal formulation development of vaccines and
the recent technological advances in formulation sciences.