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Our expertise's in Biotech-GMP consultancy:

  • Biosimilar development (from lab scale to market)
  • Support for USP, DSP, Analytics. Process development (GMP in mind)
  • Process optimization, robustness, quality
  • Technology transfers from Europe to Asia and vice versa
  • Planing/setting-up of Production Facilities for IV solutions
  • GMP conform documentation (design/writing/review of SOP's, validation plans/reports etc.)
  • Support for GMP audits (from authorities or execution of external audits)

Consultant activities for biosimilars:

  • Analysis of Reference Medical Product (RMP)
  • Cell banking (generation/testing/release of MCB, WCB, EPC and PPC)
  • USP, DSP development, up-scale, engineering batches, HCP generation
  • Development of specific analytics: HCP ELISA, hDNA assay etc.
  • Virus clearance study
  • Establishment and characterization of reference/working standards
  • Stability studies (DS, DP, RMP)
  • Formulation development
  • API production (DP toxicology study material, process validation, DP manufacturing)

Further consultancy services:

  • Routine production: data interpretation, trends, trouble shooting
  • Optimization of process robustness and efficiency
  • Up-scale opportunities
  • URS, IQ, OQ, PQ for downstream equipment
  • Validation issues
  • API storage, shipment
  • SOP review