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Southeast US-based Gene Therapy company scaling to clinical stage had been making required process liquids – lab scale – internally, but required an outsourcing partner to simplify the workflow with pre-made process liquids much larger than the internal lab could manage – and can scale to cGMP when needed.
APAC-based, > $15B market cap, global cell culture tools company focused on leveraging self-manufacturing footprint for higher-value proprietary media products and custom manufacturing for end customers.

Cell Therapy: Scaling to cGMP buffers 

US-based Cell Therapy company that is part of a global > $50B market cap biopharmaceutical company needed an external manufacturer who could make cGMP process liquids – cost effectively – in the small aliquots required for their current workflow process steps.
Northeast US-based core laboratory supporting multiple research labs was expending limited resources on down packaging FBS into smaller sized packaging (100mL) to simplify the process of aliquoting FBS by the labs and researchers supported by the core lab.
Southeast US-based biologic drug contract development and manufacturing organization (CDMO) supporting early-stage product development to cGMP commercial manufacturing had experienced significant challenges finding CMO partners willing and able to address their needs, which included small to large cGMP batch sizes, short lead times, as well as services related to stability studies for new solutions.
US-based $1B market cap biotechnology company focused on therapeutic antibodies lacked the internal cGMP liquid manufacturing capabilities to support their projects once they reach pilot scale, and required nimble partner to rapidly manufacture and adjust buffers for process optimization.
Middle Eastern-based, clinical stage Cell Therapy company needed to reduce risk and potential concerns from the US FDA regarding cell culture products with animal components.
Southeast Asian clinical stage Cell Therapy company focused on allogeneic cell therapies required custom aliquots of media components, including human serum, cytokines, growth factors, and other components in single use containment bags to simplify their workflow.