Development of a reproducible, cost effective, and cGMP compliant manufacturing process is critical for clinical and commercial success. The experts at Dark Horse know that is easier said than done and we’re here to help with navigating this challenging path. Our most widely-requested service and support options include:
Comparability studies: We design a customized roadmap for establishing equivalence to ensure that manufacturing changes (be they in location or process or both) are satisfactorily comparable, streamlining your future regulatory needs. We have extensive experience in study execution, data analysis, report writing, and drafting and submitting regulatory filings; we are also available to represent you at regulatory meetings to discuss those filings.
Process codification: We help you define and describe your process for regulators and CMOs. Our standardized frameworks have proven track records of success in regulatory filings and technology transfers.
Process evaluation: We compile the data from your scattered lab notebooks, study reports, and batch records into a comprehensive tracking-and-trending database. We evaluate this data using statistical analysis software to help you understand your process performance and trends as you never have before.
Process development planning: We help you to perform a gap analysis of your current process and develop a comprehensive product development roadmap for your product. We identify key items to be addressed at each stage of clinical development. We also assist you in developing your comparability plan to support those process changes (see: Comparability studies above).
Development of a reproducible, cost effective, and cGMP compliant manufacturing process is critical for clinical and commercial success. Failure to plan for and execute a comprehensive, phase-appropriate process development plan is a common source of product failures in Cell and Gene Therapy (C>). Our team helps you navigate this challenging path. Our most widely-requested service and support options include:
Comparability studies: We design a customized roadmap for establishing equivalence to ensure that manufacturing changes (be they in location or process or both) are satisfactorily comparable, streamlining your future regulatory needs. We have extensive experience in study execution, data analysis, report writing, and drafting and submitting regulatory filings; we are also available to represent you at regulatory meetings to discuss those filings.
Process codification: We help you define and describe your process for regulators and CMOs. Our standardized frameworks have proven track records of success in regulatory filings and technology transfers.
Process evaluation: We compile the data from your scattered lab notebooks, study reports, and batch records into a comprehensive tracking-and-trending database. We evaluate this data using statistical analysis software to help you understand your process performance and trends as you never have before.
Process development planning: We help you to perform a gap analysis of your current process and develop a comprehensive product development roadmap for your product. We identify key items to be addressed at each stage of clinical development. We also assist you in developing your comparability plan to support those process changes (see: Comparability studies above).