The protein science of biosimilars | Zendy

Martin K. Kuhlmann | Zendy; Adrian Covic | Zendy

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The protein science of biosimilars

Author(s) -

Martin K. Kuhlmann,

Adrian Covic

Publication year - 2006

Publication title -

nephrology dialysis transplantation

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.654

H-Index - 168

eISSN - 1460-2385

pISSN - 0931-0509

DOI - 10.1093/ndt/gfl474

Subject(s) - biosimilar , pharmacovigilance , innovator , medicine , profiling (computer programming) , consistency (knowledge bases) , recombinant dna , drug , biochemical engineering , risk analysis (engineering) , pharmacology , computer science , artificial intelligence , engineering , biochemistry , chemistry , intellectual property , gene , operating system

A sea change is occurring in the off-patent drug manufacturing industry with a first wave of biotechnologically derived products reaching the end of their patent lives. However, recombinant proteins are in a different league from their chemical predecessors in terms of molecular complexity. Small differences in manufacturing processes can affect the efficacy and safety of the recombinant proteins in a manner which is not always measurable using analytical or in vitro techniques. Thus, comparable clinical profiles do not automatically follow from physicochemical likeness and can only be demonstrated through clinical studies. It is essential for patient safety that both innovator and biosimilar manufacturers ensure consistency in their production, by performing rigorous purity and activity profiling between batches, and implement tailored pharmacovigilance plans.

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