Welcome to Chamow & Associates
Chamow & Associates is a leading provider of consulting services to the biopharmaceutical industry. Led by Steven Chamow, Ph.D., our skilled team of consultants provides expert advice and solutions across every stage of biopharmaceutical product development.
At Chamow & Associates, we focus exclusively on CMC—chemistry, manufacturing and controls—and specifically on biotherapeutics, including monoclonal antibodies. Our services include the four key areas of CMC: technical design for production, quality control, regulatory compliance and filing, and project management.
Managed by a team leader, our fully integrated team works with clients to develop strategic plans in product development, manage contract manufacturing organizations, design and implement manufacturing processes (cell line, process, and formulation development), and establish timelines and budgets for successful regulatory filings in the U.S. and EU.
Our experienced consultants partner with clients and CDMO’s to meet their business objectives and achieve success while reducing project risk, time and costs.
Monoclonal antibodies (mAbs) as a therapeutic modality were developed over an 11-year period, from the first production of mAbs in 1975 to the first licensing of mAb therapeutic Orthoclone OKT3 in 1986 for preventing kidney transplant rejection. Since then, mAbs have become the fastest growing class of biologic medicines and have made a huge impact ... Continue Reading →