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.
SUITE OF SERVICES FOR BIOSIMILAR DEVELOPMENT & MANUFACTURING
We have the expertise and flexibility to create tailored solutions for your unique program needs.
- Clonal cell line (master cell bank candidate) employing our GPEx®
- Biosimilar process development using DOE enabled by the ambr®platform and process characterization
- Clinical and commercial CGMP manufacturing
- A comprehensive suite of analytical capabilities
- Sourcing of innovator/comparator product
- Fill Finish utilizing vials, pre-filled syringes, and cartridges
- Clinical packaging, warehousing and global distribution
Depth of Analytical Services for Characterization and GMP Release/Stability
| CHARACTERISTIC | ANALYTICAL PLATFORM |
|---|---|
| Shape/Higher Order Structure | CD, X-Ray, NMR, Epitope Detection, Specific Binding |
| Assay/Activity | CD, HPLC, AAA, ELISA, Octet, Bioassay |
| Size/Aggregation | SEC, CE-SDS, AUC, AFA, LLS |
| Purity | RP-HPLC, SEC, Peptide Mapping, CE-SDS, FFF, ELISA, Immunoblot, DNA, LAL, Virus |
| Surface Charge | clEF, CZE, IEK |
| Carbohydrate Analysis | ESI-MS, TOF, Separation of Labeled Released Carbohydrate |
| Identity | N-terminal Sequencing, Peptide Mapping, Bioassay, clEF, ESI-MS |
| Structure/Sequence | N- and C-terminal Sequencing, Amino Acid Analysis, Peptide Map/Sequence, Monosaccharide Analysis, Oligosaccharide Mapping, Sialic Acid, MD, Disulphide Linkage |
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