Catalent offers the ability to perform a wide range of biophysical analysis with many years of analytical service experiences, technical expertise, and advanced instrumentations. This includes the characterization of novel proteins, peptides and oligonucleotides, analysis of biosimilars, characterization of reference standards, and release testing of these products. The biophysical characterization group at Catalent works closely with the client to help you understand your molecule from discovery to commercial products.
- Peptide mapping by UV or HPLC-MS and MSMS
- Protein sequence confirmation
- Disulfide Bond Analysis by HPLC-MS
- Free Cysteine Analysis
- Intact Molecular Weight Analysis (Proteins, Peptides, Oligonucleotides)
- Impurity identification by HPLC-MS and MSMS
- Glycoprofiling by HPLC-MS and MSMS for site occupancy and heterogeneity
- Post-translational modification analysis (oxidation, deamidation, phosphorylation)
- Quantitative Monosaccharide Analysis (Fluorescent detection or HPAE-PAD)
- Quantitative Sialic acid Analysis (Fluorescent detection or HPAE-PAD)
- Oligosaccharide profiling (Fluorescent detection or HPAE-PAD)
- HPLC chromatography (reverse phase, ion exchange, size exclusion)
- Electrophoresis (SDS-PAGE, IEF and 2D-gels)
- Capillary Electrophoresis (CZE, cIEF and CE-SDS
- Mass spectrometric analysis, Q-Tof LC/MS/MS, Ion Trap, MSD
- N-terminal sequencing
- Amino Acid Analysis (Peptide Content and Molar Ratios)
- Extinction Coefficient Determination
- Free Sulfhydral Analysis (Colorimetric assay)
- Blotting analysis
Facilities
- RTP, North Carolina, U.S.A. - Center for Development and Analytical
- General stats
- Over 330+ personnel in 200,000 sq. ft. of laboratory space
- 9,500 sq. ft. of GMP manufacturing for CTMs
- Project director based work teams
- Effective resource design including:
- Project management
- Project directors
- QA
- Scientific staff supported with administrative assistants
- Special material handling
- DEA-controlled substances
- Cytoxics
- High potency
- Light- moisture-, and oxygen-sensitive compounds
- Cephalosporin/penicillin
- BSL 2/3
- Hormonals
- Radioactive licenses
- Laboratory facilities
- 6 buildings in Southport Business Park
- 200,000 sq. ft. laboratory space
- 22,750 cu. ft. ICH stability
- cGMP manufacturing
- 9,500 sq. ft.
- Respiratory
- Sterile (liquid/lyo)
- Phase I/II scale
- Operational excellence
- Visual management of workload
- Metrics driven
- Value-stream approach