consulting

Consulting > BioPharma Process

Service Overview

The GxP Consulting team is able to provide your business with experience and expert knowledge in process development and manufacture of biological products and vaccines using both mammalian cell and microbial systems. The team can provide you with experience-based advice on the specific process and quality requirements for sterile, parenteral products. Our expertise covers recombinant proteins, viruses, monoclonal antibodies and bacterial products.

GxP Consulting is able to offer your business a team that has a track record in all stages of the development process. We can 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. We can support your business with post-licensing projects such as technology transfer (change of site or scale), process trouble shooting and meeting the requirements of process modification (e.g. design of comparability studies).

Strategic Consulting

  • Process development expertise for production systems based on mammalian cell and microbial fermentation
  • Process development expertise for protein purification and down-stream processing (including refolding and conjugation)
  • 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
  • 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
  • Comparability Studies
  • Process Related Documentation (e.g. SOPs, batch records, CMC related selections of CTD/BLA)
  • Management of outsourced operations (e.g. product specification, QA review, project management)