Biosimilar Development

UGA Biopharma provides Customised Biosimilar Development Services. The well-established platform technology is based on different CHO host cell lines, an optimized expression vector and the proprietary First CHOice┬« cell culture medium. UGA Biopharma has successfully completed a large number of development projects for several international biopharmaceutical companies. 

Our know-how and longstanding expertise in cell line development, bioprocess optimization, downstream development and analytics makes us the leading partner for your biosimilar development projects.

All you need from one single source in a very short development time:


Cell Line Development read more

  • Sourcing and characterization of reference drug product
  • Gene synthesis and cloning into high yield expression vectors
  • Transfection of an appropriate host cell line
  • Pool generation
  • Single cell cloning
  • Selection of highly productive biosimilar clones
  • Productivity test
  • Expression stability study
  • Cell bank generation

  • Upstream Development read more

  • Lead clone selection
  • Bioprocess optimization to improve productivity and biosimilarity
  • Upscale and consistency run in stirred bioreactors

  • Downstream Development read more

  • Development of purification methods of biopharmaceuticals from cell-culture supernatants
  • Optimization of purification and polishing methods

  • Analytics read more

  • Biosafety testing of cell banks
  • Determination of growth, titer and metabolic data of bioprocesses
  • Analytical assay development
  • Characterization of biosimilar drug product (e.g.: charge variants, peptide map, N-Glycans, SDS, WB, SEC)
  • Binding and potency assays

  • Support

  • Bioprocess transfer
  • Training and after-sales support (on request)

  • Deliveries

  • Cell banks with tested performance, stability, scalability and safety
  • Mock cell lines (on request)
  • Cell line development report
  • Cell line biosafety data
  • Cell line stability study
  • USP development data
  • Consistency run
  • DSP development data
  • Analytical data
  • Bioassay data

  • Our Success 

    UGA Biopharma successfully completed serveral biosimilar development projects. You can find further information on our homepage at: http://www.ugabiopharma.com/products/

     



    Contact us!

    UGA Biopharma GmbH
    16761 Hennigsdorf, Neuendorfstra├če 20a (Germany)
    E-Mail:  info@ugabiopharma.com This email address is being protected from spambots. You need JavaScript enabled to view it.
    Phone: +49 (0)3302 / 2024900