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Biosimilar Development and Characterization

Biosimilar Development & Characterization

Syngene is highly proficient in developing biosimilar processes as well as conducting biosimilarity assessment and biosimilar characterization. Members of our team have helped launch several biosimilar products in regulated and semi-regulated markets. We have conducted extensive biosimilarity characterization for products made by clients from the US as well as India, and have excellent systems developed to conduct product characterization and method validation.

All quality control testing, starting with raw material testing, in-process testing to finished product testing, environmental and water quality monitoring, microbiological testing, and product lot release and stability testing is carried out in-house in compliance with global GMP standards.

Biosimilar services include
  • Cell line development
  • Drug Substance and Drug Product process development
  • Basic biosimilar characterization package
  • Advanced biosimilar characterization package

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