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Recombinant Protein Drug Manufacturing

Thousand Oaks Biopharmaceuticals supports recombinant protein manufacturing, with proven success moving complex molecules into clinical trials and to market. As a CDMO, quality and compliance guide every stage, backed by mature process development, industrialization and commercial-scale capabilities.

1

Upstream Production

Leveraging proprietary platforms (MeCHOta® CHO-K1 stable cell line & pTOB high-expression vector system), we deploy flexible cultivation strategies (Fed-batch, IFB, CFB, Perfusion).
2

Downstream Purification

Targeting challenges (fragmentation, aggregation, HCP removal) in recombinant protein purification, we offer a tailored platform with key procedures
  • Affinity Chromatography: Initial target protein capture
  • Virus Inactivation: Low pH incubation/S/D treatment for viral safety
  • CEX/AEX: Removal of charge variants & impurities
  • HIC: Separation of hydrophobic impurities
  • Virus Filtration & Ultrafiltration: Final product safety & concentration
3

Formulation Production

Rooted in the QbD concept, we optimize formulations and processes via DOE, with early risk management for solution behavior, hydrophobicity, aggregation and stability.