BioPharma Process

Providing you with a wealth of experience and knowledge to help get your biopharma products and processes developed, validated, approved and to market.

GxPi is able to provide you with the knowledge and support you need in taking laboratory based concepts all the way through to full-scale pharmaceutical manufacture. This service incorporates initial process studies, where choice of the appropriate strategy will minimise time to market, through to final implementation of full-scale manufacture and process validation.

Strategic consulting

• Process development expertise for production systems covering recombinant proteins, viruses, monoclonal antibodies and bacterial products
• Process development expertise for protein purification and down-stream processing (including refolding and conjugation)
• Process and quality requirements for sterile, parenteral products
• Scale-up and technology transfer
• Feasibility studies, due diligence and expert witness work in the biotech sector
• Biosimilar (follow-on biologic or biogeneric) process development
• Analytical assay development and validation
• Process trouble shooting and meeting the requirements of process modification (e.g. design of comparability studies)
• Process optimisation, including the use of Lean Sigma methodologies to improve yields, increase efficiency, reduce failure rates, reduce costs and reduce time to market
• Outsourcing planning and strategic partnering (e.g. vendor audit, selection)

Tactical support

• Interim or ongoing, part-time technical and regulatory compliance support
• Biotech facility design services, including equipment, utilities and validation
• Project cost estimation for design build and validation activities
• Specialist biopharma project management services
• Product safety (e.g. viral or endotoxin clearance)
• Process Validation (PV) including scale-down laboratory studies
• Cleaning Validation (CV)
• Stability studies and comparability studies
• Documentation management and preparation (SOPs, batch records, CMC related selections of CTD/BLA)
• Management of outsourced operations (product specification, QA review, project management)