Q: What is your opinion on the biosimilars provision within the ACA?
The Biologics Price Competition and Innovation Act, which is part of the Patient Protection and Affordable Care Act (ACA), created a pathway for the approval of biosimilars that will help ensure the U.S. biotech community’s continued development of innovative lifesaving therapies and cures while encouraging competition to lower costs and expand patient access. BIO strongly supported passage of this provision and will continue to work with the FDA to implement it in a way that will ensure patient safety, recognize scientific differences between drugs and biologics, maintain the physician-patient relationship, and preserve incentives for innovation. The final regulatory structure for biosimilars must include mechanisms to allow for robust postmarketing data collection and evaluation along with unique trade and nonproprietary names, so that safety issues can be recognized quickly and patient risk can be limited.
Alan Eisenberg serves as executive VP for emerging companies and business development at the Biotechnology Industry Organization (BIO). He manages and directs BIO’s services and advocacy efforts for BIO’s emerging companies.
Q: Why do you believe U.S. pharma manufacturing facilities have been slow to adopt blow-fill-seal (BFS) technology?
Beyond validation, stability studies, equipment changes, and the comfort of many years of experience with glass containers, there are other technical barriers to overcome to enable the change to BFS. For instance, the inability to inspect the final product for defects, the potential for product/container interactions (product engineered for storage in glass may need to be re-engineered for storage in plastic), and extractables, leachables, and potential particle shedding are additional considerations for delivering a safe product to the patient. So far, these obstacles have been too significant for an appropriately conservative industry to overcome as the current approach for sterile injectables is safe and effective. Yet, when someone does develop a path to this technology for sterile injectable products, they will benefit from a significant cost savings in every dose they make.
James Robinson is the VP for vaccine and biologics technical operations for Merck. He supports the manufacturing strategy, process development, technical transfer, approval, and production of Merck’s vaccines and biologicals.
Q: Why do we need mixed-mode chromatography media?
Mixed-mode resins take advantage of two types of interactions simultaneously, such as ion exchange and hydrophobic interaction, ion exchange and metal affinity, and so on. A single mixed-mode resin step might in theory, therefore, replace two chromatographic steps in a process. Alternatively, the novel mixed-mode ligands also can provide for new selectivities during purification. Both can lead to reduced purification costs. The use of mixed-mode resins is increasing because, as different types of proteins begin to enter the development pipeline, new selectivities are required to tackle purification challenges. This is especially true with nonplatform IgG-based drugs (i.e. diabodies, minibodies, etc.), other immune-based therapies (IgMs), and other recombinant proteins. Working with mixed-mode resins is straightforward if one understands the forces at play. Users must know that each mixed-mode resin is different. For best results in terms of purification performance and especially for process robustness, one must screen several resins to find the best choice for the challenge at hand.
Mark Snyder, Ph.D. is manager of the process R&D applications group in the Process Chromatography Division of Bio-Rad Laboratories. He spent five years at Scios (then California Biotechnology) followed by four years as manager of process development at XOMA.