Fast. Agile. Flexible

 MiRAMAR CMC advises biotech companies on how to transfer new drugs and cancer therapies from R&D into commercial manufacturing in a way that is both fast and cost effective.

Matt Forbes, Founder

Matt is a skilled veteran with 19 years experience. He has an expert level background in current ICH, ISO, USP, FDA and EMA guidelines for in process validation, single use systems, extractables and leachables risk assessments, tech transfer, capital projects and commercial manufacturing of mAbs and cell therapy products. His focus is on optimizing Quality, costs, use of new technology and commercial manufacturing robustness and compliance.

 

Areas of Focus

  • Leading tech transfers across sites and from development

  • Process validation and CPV

  • Equipment design, commissioning and qualification

  • Health authority audits

  • CMC authoring

  • Manufacturing and Quality continuous improvement

  • COGS reduction projects

Career Background

  • Process development

  • Facility start-up and commissioning

  • Commercial manufacturing

  • Single-use technology

  • mAbs, enzymes, viral vectors and cell therapy products

  • Batch, fed-batch and perfusion platforms

Education + Industry Associations

  • B.S. Chemical Engineering, Northeastern University, 2001

  • M. Eng. BioEngineering, U.C. San Diego, 2008

  • ISPE Member