Monoclonal Antibody
mAb
- Global antibody manufacturing with over 85,000 L capacity
- cGMP scale 1,000 L to 12,000 L
- Full pharmaceutical support
Process Development
- Offer full development package
- Cell line development
- Analytical development
- Late clinical transfer
- PPQ efforts to post-commercial offering
- Cell culture process development
- Purification process development
- Media development and optimization
- Analytical method development
- Extended product characterization
- Viral clearance studies
- Provide technical expertise and assistance from cell line development to commercialization
- Process transfer/development method (analytical, scale-up, etc.)
- Process validation and mapping
- Process data trending
- Continuous process verification
- Quality assurance
- Quality control
- Project management
Analytical Development, Release & Stability
- HPLC (SEC, IEX, affinity, reverse phase)
- Host cell protein
- Electrophoresis (CE, IEF, SDS-PAGE)
- ELISA
- Peptide structure determination (LC, MS)
- Oligosaccharide analysis
- DNA quantification (threshold)
- Spectrophotometry (FT-IR, US VIS)
- Bioburden/endotoxin
Conjugation
Capabilities
- Designated and tested facility able to handle compounds with OEL down to < 10 ng/m3 containment
- Handle up to category 5 compounds: auristatin, PBD, and calicheamicin
- Process validation
- 2.5 L to 32 L columns
- cGMP conjugation for clinical and commercial
- Preparation of GLP tox material
- Single-use TFF unit with membrane capacity up to 2 m2
- Reactor volume 30 L to 500 L stainless steel and single use
- Single-use chromatography columns used on Akta skid
Process Development
- Formulation development
- UF/DF development
- Manufacture material for pre-clinical studies including analytical characterization
- Chromatography methods development
- Conjugation scale for process development up to gram scale
Analytical Development, Release & Stability
- Onsite quality and testing
- R&D onsite testing
- UV/VIS
- MALS/IR
- CE, icIEF
- CE-SDS (Beckman), mCE-SDS (Perkins Elmer)
- HPLC, UPLC, LC/MS
- LAL
- ELISA
- Environmental/bioburden testing
- HIC for DAR