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Process Development

Successful process development enables a smooth and rapid path from cell line development to commercial product delivery. In preparation for cGMP production, the process development team designs manufacturing processes to support Phase I – III clinical trials and assesses how robust a process is, how it behaves as conditions are altered, and what the critical factors are for success.

Process validation is then implemented at Phase III to secure a commercial quality process for delivering reliable product supply. The team is also experienced in optimization of individual steps in an existing set of unit operations to confirm the overall process is best-suited for cGMP production.

Key Services:

  • Technology transfer / Optimization of client processes
  • Process verification
  • Conjugation process development milligram to gram scale
    • Small scale conjugation screening for research-stage clients
  • UF/DF development
  • Chromatography methods development
  • Formulation development
  • Material generation for pre-clinical studies including analytical characterization
  • Experience with wild-type stochastic conjugation technology, as well as, site-specific conjugation technology
    • Optional AJICAP® site-selective conjugation technology screening offering