Search Results

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.

Southern US-based cell therapy research lab, located at world renowned cancer research institution, investigating the use of genetically modified CAR NK cells was experiencing inconsistent cell biological activity due to IL-2.

US government Cellular Engineering Product Development Laboratory, supporting > 50 active INDs and Phase I/II clinical trials, faced challenges and delays related to questions from the FDA.

US-based, pre-clinical stage Gene Therapy innovator scaling products from benchtop to pilot required a nimble liquid manufacturing partner to rapidly manufacture and adjust buffers for process optimization.

US-based clinical stage Cell Therapy company focused on allogeneic platform needed to secure supply for Yssel’s T-Cell media to confidently meet their manufacturing scale up following positive results from their clinical development process.

EU-based, > $10B market cap, global bioprocess tools and solutions manufacturer needed increased US-based capacity to reduce lead times and improve customer experience.