Biologics / Large Molecule Analytical Services
OVERVIEW
Our Advantages Catalent Services
At Catalent Biologics, we understand the increasingly complex analytical and regulatory requirements for biologics and other large molecules and also new technologies and techniques that can be employed. We offer one of the broadest ranges of biologics and other large molecule analytical services in the industry, all under full CGMP compliance. Our biologics analytical services can be provided as a standalone service or integrated into development and manufacturing. We provide services for drug substance, drug product, and intermediates, both New Biologic Entities and Biosimilars/Biobetters and can provide support throughout the drug development pipeline, from pre-clinical testing through to post-approval release and stability. Through our experienced scientific team and range of capabilities, our goal is to serve as a strategic partner that can support all our customers’ analytical development and testing needs.
OUR ADVANTAGES
- Comprehensive breadth of capabilities spanning multiple disciplines
- CGMP compliance with strong regulatory track record
- Flexible and responsive
- Specialized capabilities and innovative technologies, including automation, under full CGMP
- Catalent has experience working with many classes of large molecules including but not limited to:
- Peptides: Conjugated peptides, PEGylated peptides, fusion peptides
- Proteins: Glycosylated proteins, non-glycosylated proteins, fusion proteins, conjugated proteins (ADCs), monoclonal antibodies (mAbs), polyclonal antibodies, bispecific antibodies
- Physio-chemical Testing
- Oligosaccharides
- Vaccines
CATALENT SERVICES
- 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