what do we need gmp compliant facility (r1 billion 2008) flow, segregation, containment,...
TRANSCRIPT
What do we need
GMP compliant facility (R1 billion 2008)
Flow, segregation, containment, environmental, statutory Modern technologies for raw material, intermediate and final
product testing Invirto, invivo, reduce, refine, replace Commercial validated Elisa kits R5k /100 test
Masterseed/ cell analyses +160 strains, Certified Authority R1m/product
Strain ID, purity, BVD, Mad cow, Mycoplasms etc Stability/shelflife infrastructure, qualified people, time
Containment labs Zoonoses
| Onderstepoort Biological Products © |22nd February 2013 Page 43
What do we need
Achieve higher quality through continual improvement Labour intensive Training/ capable staff Quality Control test research & development Validation Reference material Proficiency testing Equipment- reproducible, Automised or IT controlled maintenance &
validation Supplier compliance & audits GMP increase cost
| Onderstepoort Biological Products © |22nd February 2013 Page 44
What do we need
Small animal unit back to compliance HVAC, steam, building management system Specific pathogen free animals Time for breeding
Large animals Animal ergonomics Test facility
In vivo R&D to move to invitro ISO 17025/ GCP Bio-security
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Benefits
GMP compliance Globalisation and competition Product according client need Product to regulatory compliance (Product, environmental, Bio
containment etc.) Sustainability
Contract work (production, quality control & clinical work) Reference lab
Fulfil expectation Shareholder, customer, employee & supplier
Be a global biotech manufacturer
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R&D and Production
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R&D and Production
ResearchDevelopment
Application TestingPilot Product
positive cash flow
negative cash flow
5-10 years several years
product life-cycle
production
R&D
• Chlamysure vaccine : 2003-2009• B-Phemeral vaccine : 2003-2009• RVF vaccine Clone 13: 2001 – 2009• Average R&D spend of OBP per annum (2000-2010)
• R 2 – R 2.5 million, <4% of revenues generated (multinationals able to invest (12-20% in R&D)
• Cost of new product development: average R7m - R 10m| Onderstepoort Biological Products © |22nd February 2013 Page 48
Vaccine Bank/Reserve
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Vaccine Bank and Reserve
• Categories of animal vaccines requiring different approaches:• generally used vaccines which are driven by commercial imperatives and • strategic vaccines which are of vital importance to the country and region in terms of
controlling and eliminating diseases (eg AHS, FMD, RVF) (which require and should receive state support)
• Vaccine Bank and Reserve (contingency vaccines)• Reserve: rolling stock • Bank: bulk and/or ready to use : to ensure product availability and rapid response in
case of threat of outbreaks • Vaccines against diseases that can have devastating effect to the economy of the country
(in terms of trade, food security and safety)• Vaccines for which there is unique expertise in research, development and production,
mainly because of their restricted distribution to Africa, or in some cases to South Africa• Vaccines against transboundary and other exotic diseases that are a threat to South Africa• OBP’s products, as well as other local and international suppliers• OBP has already approached by an international organisation to establish a vaccine bank for RVF for Africa
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Production and related challenges
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Stages in Vaccine Production
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* in-process testing
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