New molecular formats are gaining momentum in today’s market. They are extremely diverse and can often encompass multiple chains and multiple domains, which presents unique challenges during process development and manufacture. Included in these more complex product types are fragment antigen-binding (Fab) and Fc-Fusion proteins. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat.
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Mammalian
Parenteral Drug Product
Fabs, Fusion, Scaffold and other Recombinant Proteins
Analytical Development
Cell Line Development
Manufacturing: GMP Drug Product
Manufacturing: GMP Drug Substance
Parenteral Drug Product Development
Author(s):
Nicholas Field
Principal Scientist, Purification Development and Virus Clearance
Stuart Jamieson
Global Technical & CMC Director
Pedro Marques
Principal Scientist, Analytical Development & CMC Expert, Lonza Drug Product Services
Eddy Berthier
Associate Principal Scientist, Pharmaceutical Development Group Lonza Drug Product Services
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