Research - Encinitas, California, United States
Precision CMC BioProcess Consulting provides strategic and technical Chemistry, Manufacturing, and Control (CMC) consulting services to the biopharmaceutical industry to help clients achieve their product development and commercialization goals. We have experience working with global teams on a wide range of biologic molecules (mAbs, recombinant proteins, viral vectors, cell therapies) from a variety of expression systems (mammalian, microbial, transgenic). Precision CMC specializes in supporting: • Cell Banking • Upstream & Downstream BioProcess Development/Optimization • Formulation Development • Process Scale-Up • Tech Transfer • GMP Manufacturing (in-house & outsourced) • Fill/Finish (sterile liquid and lyophilized formats) • Clinical Packaging & Logistics • Cold Chain Packaging & Logistics • Technical Project Management • Interim management and CMC development for smaller or virtual companies • CMC Due Diligence • CMC Regulatory • CDMO Outsourcing (RFP & evaluations, negotiation, project management, technical support, PIP)Let us be the expertise or resource multiplier you need to meet your goalsFor more information on Precision CMC's capabilities & services, email info@precisioncmc.com
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