Process & Assay Development & Validation

The journey from lab bench to bed side is very much dependent on process development which could address manufacturing scale up and reproducibility.

ACTRIS would facilitate by partnering with the clients to convert their research protocols into operational manuals and workflows in compliance with relevant cGMP, safety, and regulatory standards. The process development services will also aim at incorporating various regulatory-compliant manufacturing equipment to incorporate automations.

Considerations for process development would include facility requirements, equipment, reagents, consumables, and personnel training. Developmental studies and mock-ups would be initiated as part of the process. Therefore, the partnership strives to resolve translational hurdles thereby paving the way for clinical applications of the novel technologies.

Process Validation and SOP Development

Consistency and reproducibility are some of the upmost concerns in achieving quality cell, tissue, and gene therapy products. Hence process validation of various standard operating procedures (SOPs) generated during process development is critical in meeting such requirements.

In house support is rendered in this area in order to realize the process development plans to yield actual products of potential clinical and commercial significance. This would entail repeated validation runs (using the finalized ancillary materials), identification / verification of the Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).