CMC Support

Your early-stage biologics CMC support could include:

  • Process and analytical development and troubleshooting

  • QBD (TTP, QTTP, DS and DP CQA assessments)

  • Detailed DS and DP descriptions including CPP, KPP, IPM, IPC identification

  • Comparability protocols and reports

  • Reference standard qualification protocols and reports
  • Specifications justification

  • Risk assessments (e.g. for filter validation, manufacturing)

  • SOPs

  • Batch manufacturing record preparation and review

  • Technical reports for process or analytical development

  • Strategy documents

  • Technical writing for Module 3