Biologics / Large Molecule Analytical Services
OVERVIEW
Our Advantages Catalent Services
Catalent provides a powerful range of large molecule analytical services for both traditional biologics as well as advanced therapies, such as antibody-drug conjugates (ADCs), cell and gene therapies, mRNA, vaccines, and more. These services, covering drug substances, drug products, and intermediates, are conducted at our various biologics analytical labs, with our center of excellence in Kansas City, Missouri. With over 30 years of experience, our seasoned experts deliver tailored solutions to meet your specific needs, regardless of complexity, scale, or timeline.WHY PARTNER WITH US?
EXPERIENCE AND INFRASTRUCTURE
- 200+ scientists
- 31,000+ ft3 stability storage capacity
- 800+ assays and techniques offered
- 300+ client programs supported
PROVEN EXPERTISE
- Average tenure of leaders with 20+ years’ experience within large molecule analytical services
- 30+ years of experience across pre-IND to NDA / BLA / MAA and commercial release
PHASE-APPROPRIATE TAILORED SOLUTIONS
- Full release and stability support under one roof
- Reliable routine to specialized assays, including orthogonal approaches and complex troubleshooting
- Leading partner with tenured experts supporting method development
CATALENT SERVICES
EXPERIENCE WITH A BROAD CLASS OF MOLECULES
- Monoclonal, polyclonal, and bispecific antibodies
- ADCs and bioconjugates
- Recombinant, fusion, and pegylated proteins
- Cell and gene therapies
- Vaccines
- Oligosaccharides
- Oligonucleotides and aptamers
- Nucleic acids
- Nanoparticle delivery systems
LARGE MOLECULE ANALYTICAL SERVICES
- Method establishment (method development, optimization, validation, transfer, etc.)
- Quality control and compendial analysis
- Biophysical testing
- Cell-based and binding potency assays
- Molecular biology assays
- Stability testing and storage
- Developability and pre-formulation studies
- Process Development Support