Spring Intro 2023

06/03/2023

Changes to the manufacturing process will result in a different “heterogeneous” product

Unit Operation

Specific to Product

Cell line, growth media, method of expansion Cell line, growth media, bioreactor conditions

Cell Expansion

Cell Production in Bioreactors Recover through filtration or centrifugation Purification through chromatography Characterization and Stability

E Q -1

E Q- 1

Operating conditions

Binding and elution conditions Methods, reagents, reference standards

Purified Bulk Drug

Process defines the product

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Numerous ICH Guidelines Cover Manufacturing of Biotech Products

Q5A Viral Safety

Q5B Genetic Stability

Q5C Stability

Q5D Cell Substrates

Q6B Specifications

Q7 GMP

Quality by Design (Q8 Pharm Dev, Q9 Risk Management, Q10 Quality Systems)

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