Company required complex media supplemented with human AB serum for their allogeneic cell therapy platform. The company needed custom aliquots of media components, including human serum, cytokines, growth factors, and other components in single use containment bags, as well as custom manufactured process liquids to support their workflow.
The company’s internal manufacturing constraints required outsourcing of media manufacturing and packaging to a cGMP contract manufacturer to ensure cGMP requirements were met.
GeminiBio collaborated with the company to document detailed product specifications and requirements, including all component specifications and release criteria requirements, completing feasibility and the custom product proposal within 7 days for the customer’s specific custom media and buffers.
GeminiBio executed pilot batches and completed required testing for company review/ approval. Following approval, GeminiBio manufactured production runs of required products in 100 mL to 10-liter bioprocess containers and in batch sizes from 500-liters to 2,000-liters, and shipped to customer within 8 1/2 weeks of purchase order receipt.