Cell and gene therapy manufacturing facility planning

Challenge: A new GMP facility for the production of investigational cell and gene therapies needed regulatory, market and technical advice before committing to a capacity expansion.
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Providing regulatory strategy for T-cell therapy

Challenge: Our client is a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies for serious diseases. The client wanted to understand whether...
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Treg cell therapy commercialization plan

Challenge: The commercialization arm of a leading university wished to identify its most promising therapeutic programs within its purview in order to allocate internal translational funding to...
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Cell therapy CMC regulatory affairs & pharmacology & toxicology support

Challenge: Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell therapies and proprietary...
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R&D pipeline planning for gene therapy company

Challenge: A biotechnology company developing proprietary synthetic biology technology in gene therapy expression for several clients was looking to evolve its business model. The company engaged...
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Competitive and market landscape for CAR T-cell therapy

Challenge: A biotech company developing a platform technology to improve the safety of CAR T-cell therapies asked Alacrita to conduct a comprehensive competitive landscape to better understand the...
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