Process Development
Process Development Services
Pharmaron offers comprehensive process development services for various biotherapeutic molecules including monoclonal antibodies, bi-specific antibodies, fusion proteins and other recombinant proteins. Our cell line development platform can provide services from DNA sequence to cell banking.
Pharmaron’s holistic cell culture process development services cover media screening, feeding strategy definition, cell culture process parameter optimization, process characterization, process scale-up and technology transfer. We can offer downstream purification process development, from resin screening to process optimization and technology transfer. In addition, our formulation and process development teams provide services to develop different dosage forms including liquid, lyophilized, or frozen drug products filled in vials, cartridges or pre-fillable syringes.
Capabilities
Cell Line Development
- Gene synthesis and codon optimization
- Vector construction and transfection
- Clone selection
- Research cell bank (RCB) creation, testing, characterization
- RCB stability studies
Upstream Process Development
- Culture media screening
- Feeding strategy definition
- Process parameter optimization
- Process lock and confirmation (15 – 50L)
- Process scale-up
- Process characterization
- Technology transfer
Downstream Process Development
- Platform technology for mAbs and Fc fusion proteins
- Customized purification processes for recombinant proteins, bi/multi-specific mAbs
- Cell culture harvest and clarification process
- Resin screening
- Chromatography process development
- Viral clearance studies
- Ultrafiltration (UF)/Diafiltration (DF)
- Process characterization
- Process scale-up
- Technology transfer
Drug Product Development
- Molecule developability assessment
- Physiochemical property characterization
- Stability assessment
- Forced degradation studies
- Liquid and lyophilized product development
- Pre-filled syringe drug product development
- Container closure compatibility
- Container closure integrity
- Extractable and leachable
- Biophysical characterization
- Stability studies and data trending
- Drug product fill-finish process development
- Technology transfer
- Tox in-use compatibility and stability studies
- Clinical in-use compatibility and stability studies
- Forensic analysis
