biotechnology products & regulatory requirements medical writer group nl naarden, 8 dec 2005...
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Biotechnology Products & Regulatory requirements
Medical Writer Group NLNaarden, 8 Dec 2005
H.F. Schuring
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Definition of Biotechnology
• Bio – deals with living organisms
• Technology – involves the practical application of knowledge
Therefore, Biotechnology is the practical application of knowledge related to living
organisms
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Biotech vs Biologicals
• Biologicals are products which quality, purity, specificity, and potency cannot be expressed completely by chemical and physical terms (UK approach)
• Origin, manufacture and structure are not mentioned, therefore includes– immunological products (vaccines, toxins, serum,
and allergens -89/342/EC)– products from human blood or plasma -
89/381/EC
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Wide Range of Products
• New molecular entities:– Recombinant DNA products
• CHO products• Proteins from milk of transgenic animals
– Gene therapy products
– Cell therapy products
– Monoclonal antibodies
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Evolution of Biotechnology
10,000 BC: Alcohol fermentation, bread, cheese & yogurt
5,000 BC: Beer is brewed in Egypt
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Evolution of Biotechnology (Overview)
• Whole Organism (macroscopic level)• Cells and other Microorganisms• Subcellular
– Components of the cell (organelles)– What did these components do?
• Nucleus and its Genetic Material– How did this material control the cell?– How was this information passed on
as the cell divided?
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1953
Watson & Crick resolve the double helix structure of DNA
Evolution of Biotechnology 1800 - today
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Key Developments in Biotechnology
• Cell Culture (bacteria, yeast, CHO)
• Monoclonal Antibodies
• Molecular Biology– Genetic Engineering– Recombinant DNA Technology– Transgenic Animals– Cloning
• Stem Cells (Great Potential)
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Commercial Production
Level Control
Medium Product BaseBioreactor with Packed Bed
Addition
HarvestAddition
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Quality
Purity - Impurity
Biological properties
Immunological properties
Strength
Potency
Safety Efficacy
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Implication of the manufacturing process on a r-DNA biotech product
• The process defines the product
and
• The process determines the quality and reproducibility
Note: case by case assessments
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Regulatory Requirements
• Quality, Safety and Efficacy– Less guidance available compared versus NCEs
• Quality specifics:– Characterization– Viral safety– Cell banking
• Preclinical specifics:– ICH S6 versus ICH M3– Immunogenicity
• Clinical specifics:– dependent on product– Immunogenicity