Precision Cmc Bioprocess Consulting

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 line development and cGMP Cell Banking • Upstream & Downstream BioProcess Development/Optimization • Formulation Development • Process Scale-Up • Technology Transfer • GMP Manufacturing (in-house & outsourced) • Fill/Finish (sterile liquid and lyophilized formats) • Clinical Packaging & Logistics • Cold Chain Packaging & Logistics • Technical Project Management • Strategic CMC product development plans • Interim CMC management for smaller or virtual companies • CMC Due Diligence & Technical Evaluations • CMC Regulatory Strategy • Make vs. Buy, and COGs Analyses • CDMO Outsourcing (RFP evaluations, selection, negotiation, project & technical management) Let us be the expertise or resource multiplier you need to meet your goals For more information on Precision CMC's capabilities & services, email adam@precisioncmc.com