Contact: Christopher Garbe
Contact phone: (206) 667-7541
Contact e-mail: firstname.lastname@example.org
Process development services are far ranging and include pre-clinical development of scaled-up optimized production methodologies to satisfy parameters of product yield and functionality, compliance with requisite safety and release specifications and other regulatory requirements, development of standard operating procedures and batch records, and performing pilot studies and validation of key systems prior to process transfer and initiation of full clinical manufacture.
The development lifecycle for both biological and cell therapeutic projects can be complex. Typically, these require initial assessment of existing research laboratory-based procedures, conversion to cGMP compliant materials and clinical-grade reagents, process optimization to address culture conditions and scale-up issues, development of standard operating procedures and appropriate batch records for documentation, followed by completion of an appropriate number of pilot or full-scale validation studies prior to IND submission and initiation of therapeutic manufacturing.
For example clinical projects utilizing production capabilities encompassing both biological reagents and cellular components typically require a concerted development effort of up to two years prior to delivery of an approved product. This timeframe is not unusual for those projects intended for clinical manufacture.