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Biosimilar Development & Manufacturing

ADVANCED TECHNOLOGIES AND INTEGRATED SERVICES FOR BIOSIMILARS

Catalent Biologics has extensive experience in biosimilar development and manufacturing, with multiple biosimilar products on the market utilizing our technology and manufactured in our facilities. We offer flexible and customizable solutions beginning with cell line development all the way through finished product supply. Our portfolio of developed cell lines can help accelerate your biosimilar development across multiple therapeutic areas.

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SUITE OF SERVICES FOR BIOSIMILAR DEVELOPMENT & MANUFACTURING

We have the expertise and flexibility to create tailored solutions for your unique program needs.

Depth of Analytical Services for Characterization and GMP Release/Stability

CHARACTERISTICANALYTICAL PLATFORM
Shape/Higher Order StructureCD, X-Ray, NMR, Epitope Detection, Specific Binding
Assay/ActivityCD, HPLC, AAA, ELISA, Octet, Bioassay
Size/AggregationSEC, CE-SDS, AUC, AFA, LLS
PurityRP-HPLC, SEC, Peptide Mapping, CE-SDS, FFF, ELISA, Immunoblot, DNA, LAL, Virus
Surface ChargeclEF, CZE, IEK
Carbohydrate Analysis ESI-MS, TOF, Separation of Labeled Released Carbohydrate
IdentityN-terminal Sequencing, Peptide Mapping, Bioassay, clEF, ESI-MS
Structure/SequenceN- and C-terminal Sequencing, Amino Acid Analysis, Peptide Map/Sequence, Monosaccharide Analysis, Oligosaccharide Mapping, Sialic Acid, MD, Disulphide Linkage

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WHY CATALENT FOR A BIOSIMILAR DEVELOPMENT SOLUTION?

  • Multiple marketed biosimilar mAbs utilize GPEx®technology, multiple marketed biosimilars manufactured in our facilities
  • High performance, high yield cell line development with GPEx®technology
  • Experience with process development and process characterization
  • Comprehensive biosimilarity expertise and analysis tailored to your needs
  • State-of-the-art clinical and commercial biomanufacturing capabilities
  • A spectrum of fill/finish solutions, including the award winning Flexible Filling Line
  • Experience in device assembly and packaging for biosimilars
  • Industry leading clinical trial supply with reference drug sourcing and blinding