PRA Adds Large Molecule Capabilities To Laboratory

PRA, a clinical research organization (CRO), announced in a press release that it has added large molecule capabilities to its immunochemistry services at its laboratory in Lenexa, Kansas. The additional service positions PRA as a full-service CRO with bioanalytical capabilities.

Chad Briscoe, executive director at Science & Innovations Bioanalytical Laboratories said, “By expanding our services to large molecule bioanalysis, we can now support all types of clinical trials.”

Large Molecule Bioanalysis

Large molecule bioanalysis is increasingly needed due to the rapid development of biosimilars (generics) in recent years. As patents expire, pharmaceutical companies seek to bring biosimilars to market and the Food and Drug Administration (FDA) is working to expedite approvals for generics. However, biosimilars are more difficult to formulate and more costly to produce. Additionally, due to possible immune responses, biosimilars raise safety issues. The payoff is often uncertain as biosimilar manufacturers and marketers must compete for market share with brand names.

FDA Guidance

The FDA has issued guidance to industry with advice on biosimilars, including the scientific and quality considerations in demonstrating biosimilarity. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research has said, “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.” The guidance provides biosimilar manufacturers a step-wise plan to comply with regulations.

The FDA says that clinical pharmacology studies are a critical part of biosimilarity demonstrations, ensuring that there are no meaningful differences between the generic and reference product. If done well, the agency says that it adds to the totality of the evidence and reduces uncertainty. The agency recommends using appropriate analytical methods based on the nature of the molecules being characterized. PRA and other CRO laboratories make use of several analytical methods, including mass spectrometry, ligand binding assays, flow cytometry, and radioisotope studies. 

PRA

PRA focuses on early development support in The Netherlands and in the U.S. It has staff, clinic space, and laboratories to develop and test compounds. PRA has been providing expertise in drug development since 1976 and has staff in over 80 countries. The company has worked on orphan drugs, niche treatments, and blockbuster drugs.