Large Molecule Analytical Bioassays
Catalent offers a wide range of biopharmaceutical services to support drug substance, drug product, and intermediates for large molecule compounds, both innovator drugs as well as for biosimilars/biobetters. Our bioassays provide support throughout the drug development pipeline, from pre-clinical testing through to post-approval commercialization. Catalent’s capabilities extend to GLP support and testing and GMP methods and testing services. These include method development/optimization support, method transfer or phase-specific validation support. We perform reference standard characterization and qualification testing, and characterization/investigational tests. Our laboratories also undertake oligonucleotide analysis, amino acid analysis, release tests, stability tests, purity assays, bacterial and endotoxin assays, in-process tests, n-terminal sequencing, and immunogenicity PK and PD testing support.
Catalent's Biopharma Advantages
- Our comprehensive breadth of techniques span multiple disciplines and, therefore, provide comprehensive and orthogonal analytical capabilities for physico-chemical assays, functional/potency assays, binding assays, molecular biological assays, and microbiological assays.
- Our analytical assays and compendial testing delivers robust compliance and regulatory documentation, positioning clients’ drugs for regulatory filings and approval, both in the US and worldwide.
- With Catalent’s global network of manufacturing services, clients gain comprehensive solutions with an integrated approach. Our biopharma lab services can be integrated with our global biologics manufacturing and packaging facilities. However, if clients need one-off GLP or cGMP support, analytical assays or characterizations, Catalent readily and efficiently delivers those services.
- Our analytical testing for large molecules is supported by our facilities in Kansas City, Missouri, and Research Triangle Park, North Carolina. We encourage site visits to further the positive experience of working with us.
- Development/optimization support
- Method transfer or phase-specific validation support
- Reference standard characterization and qualification testing
- Characterization/investigational testing
- Release testing
- Stability testing
- In-process testing
- GLP support
- Immunogenicity PK and PD testing support