BioProcess Technology Consultants, Inc.

BioProcess Technology Consultants (BPTC) is the recognized global leader in providing Chemistry, Manufacturing, and Control (CMC) consulting services to the biopharmaceutical industry. We know that success in every phase of biopharmaceutical development requires specialized skills, so we offer you an integrated team of knowledgeable consultants with the experience and skills that you need. The depth of our experience plus our knowledge of emerging technologies and regulations can help you navigate the technical and regulatory hurdles along the path from clone to commercial®, shortening time to market, and enhancing overall company value.

Established in 1994, we have served over 400 satisfied clients, helping them achieve key business objectives and make sound investment decisions. Ourexpertise includes development of upstream and downstream manufacturing processes, quality control testing and characterization, cGMP compliance, and validation of manufacturing processes and facilities. We offer customized cGMP and QbD training and provide CMC regulatory support including preparation of regulatory submissions to FDA, EMA, and others. BPTC also maintains proprietary databases covering global biopharmaceutical manufacturing capacity and biopharmaceutical products in development or on the market which can be used to analyze and forecast market and manufacturing capacity as well as identify target market segments for emerging technology or service offerings.

Specialties

bioprocess, outsourcing, CMC, manufacturing, strategy, fermentation, cell culture, purification, analytical, QA, regulatory, supply chain