Sponsors developing and manufacturing protein therapeutic products use a number of analytical tests (e.g., cell-based potency and chromatographic assays) to assess quality attributes of their active ingredients and drug products. Tests are conducted for a number of purposes, including characterization, comparability, lot release, and confirmation of stability. This two-part article includes the findings of the California Separation Science Society (CASSS) Chemistry, Manufacturing, and Controls (CMC) Strategy Forum titled “Reference Standards for Therapeutic Proteins: Current Regulatory and Scientific Best Practices and…

Risk assessment is used as a vetting tool to determine areas of influence and uncertainty regarding key factors for critical responses. It helps biopharmaceutical companies build both product and process knowledge during development. Every formulation, unit-operation characterization, and design optimization should begin with risk assessment and ends with an understanding of sensitivity, the quantified influence of key factors, improved control logic, edge-of-failure determination, and a qualified design space. Quality Risk Management Quality risk management (QRM) is an essential element in…

The concept of “lean thinking” is applied with increasing frequency in a number of industries, including biopharmaceutical manufacturing, to eliminate waste and optimize workflow. Lean thinking refers to focusing on standardizing processes within workplaces to minimize redundancies and improve value. Safety also is important to every workplace, especially in biopharmaceutical manufacturing because it uses process chemical ingredients. By embedding attention to safety into the practice of lean manufacturing, companies can improve employee buy-in of lean initiatives while reinforcing the importance…

Recently I spoke with editorial advisor Hazel Aranha (manager of viral clearance and safety at Catalent Pharma Solutions) about viral contaminants and risk management. A recognized expert in the field, Aranha contributed “Current Issues in Assuring Virological Safety of Biopharmaceuticals” to BPI's March 2012 issue and was interviewed by Ellen Martin for her September 2012 article, “Legacies in Bioprocessing.” Spotlight on the Industry BPI: Have there been any recent viral transmission incidents that you can share to highlight the concern…

In 1982, authentic human insulin produced in genetically engineered Escherichia coli (under the trade name Humulin, from Genentech) was the first recombinant protein to be licensed by regulatory authorities for therapeutic use. That licensure and the subsequent production of human growth hormone heralded a new era of biopharmaceuticals and were the first examples of the industry's future potential. Both proteins are produced as fully active biologicals in E. coli. Insulin and human growth hormone are fairly simple small proteins, without…