Biosimilar Development
Biosimilar
development belongs in the hand of experts. UGA Biopharma is your expert with
respect to biosimilar development. We can develop your desired biosimilar within
a very short time frame. 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.
Cell Line Development read more
Sourcing and characterization of reference drug product Gene synthesis and cloning into high yield expression vectors Transfection of 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 several biosimilar development projects. You can find further information on our homepage at:
www.ugabiopharma.com/ready_to_use_biosimilar_cell_lines/
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Contact
UGA Biopharma GmbHNeuendorfstraße 20a
16761 Hennigsdorf
Germany
E-mail: info@ugabiopharma.com
Phone: +49(0)3302 / 2024900