Biosimilar Development at Aragen

Over the past decade, the Aragen team has successfully expressed biologics including antibodies, antibody fragments, bispecific antibodies, fusion proteins, hormones, and growth factors. Aragen offers high-expressing cell lines for Biosimilar development.

Cell Line Development for Biosimilars

  • RapTr2022 with HIGH TITRE and REDUCED TIMELINE- Royalty-free CHO DG44 and CHO GS platforms.
  • Our in-house developed CHO DG44 platform can deliver titer >4g/L in 5 months.
  • Aragen also offers a CHO GS platform that can deliver titer >6g/L in 5 months.
  • Our CLD platform uses a chemically defined serum free medium and proof of clonality to support IND filing.
  • Robust upstream and downstream process development (250 ml high-throughput multi-parallel robotic bioreactor
    systems, e.g., Ambr250) to match originator molecule.

Comprehensive analytical and bioassay packages to support clone selection of Biosimilar Cell Line Development: Trastuzumab

  • Generation of clonal cell lines.
  • Evaluation in Fed-batch Shake flask.
  • Validation of shake flask data in AMBR250 and Bioreactor.
  • Analytics to meet the characteristics of Innovator Lot

Adalimumab using Aragen’s proprietary Vector.

  • Stable bulk pool (BP) evaluation reached ~700mg/L.
  • Mini pool (MP) generated, and MP reached up to 4.2g/L.
  • SCC generated from the top two mini-pools and fed-batch shake flask reached up to 6 g/L.
  • Single cell clones show stability over 60 days in respect to cell growth, maintaining high viability and specific productivity.
  • Using Aragen’s optimized process from transfection to single cell clone evaluation completed in 18wks.

Process Development

  • Media adaptation
  • Shake flask fed batch evaluation with dierent media and feed.
  • Scalable and consistent data from shake flask to 1L and 5L Bioreactor in terms of VCD and titer profile

Analytical Characterization

  • Rigorous and Comprehensive Analytics to Support Biologics Discovery and Development
  • Aragen Analytics capabilities include CE-SDS, cIEF, SEC-HPLC/MALS, LC/MS, DLS/SLS, LAL, HIC, HILIC, and SPR/BLI.