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PROCESS DEVELOPMENT

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 common source of product failures in the Cell and Gene Therapy Industry. Our team helps you navigate this challenging path. Our most popular services include:

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.

Process Flow Diagram
Process Dev Diagram

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 common source of product failures in the Cell and Gene Therapy Industry. Our team helps you navigate this challenging path. Our most popular services include:

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 Flow Diagram

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 Dev Diagram

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.