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 CMOs to meet their business objectives and achieve success while reducing project risk, time and costs.
Because recombinant protein therapeutics are genetically engineered, they have the potential to induce an immunogenic response in a patient. Immunogenicity risk, as defined by the formation of anti-drug antibodies (ADA), is a significant event that can compromise patient safety... Continue Reading →