Q: What challenges need to be overcome to increase adoption of single-use manufacturing technologies?
The adoption in large pharma companies is slow for a variety of reasons – extractables and leachables analysis, challenges of vendor change control, and lack of connectivity of equipment from various suppliers which could result in a supply chain manufacturing gap. One of the newest emerging issues is the control of particulates (extraneous matter) that may shed from single-use components during processing. Extraneous matter is a growing concern of regulators and manufacturers alike. The control of particulates is a high-priority topic of the user community of the Bioprocess Systems Alliance (BPSA). Leveraging learnings from other industries (e.g. chip manufacturing) should benefit this cause.
Jim Robinson is the VP for vaccine and biologics technical operations for Merck & Co. In this role, he supports the manufacturing strategy, process development, technical transfer, approval, and production of Merck’s vaccines and biologicals.
Q: Is the presence of Bisphenol A (BPA) in single-use products a deal breaker?
No. Most single-use components are made from polymers that are not made with BPA monomers, and are thus BPA-free. Examples include polyethylene film biocontainers, silicone and thermoelastomeric tubing, polypropylene tubing connectors, and filter hardware and membranes. Toxicity studies have failed to show toxic effect in humans at levels found in food-product leachables. Polymers used for medical devices and single-use bioprocess components made using BPA are from medical-grade resin formulations and processes that do not yield detectable BPA migrants, even under exaggerated extraction conditions. Demonstrated absence of detectable BPA from those components has enabled them to be deemed acceptable by both the FDA and EMA for use in medical devices and biomanufacturing. Public concerns with BPA from food or drink containers does not extend to drug manufacturing and medical devices where BPA migrants are already excluded and where health benefits outweigh unproven risks.
Jerold Martin is a senior VP of global scientific affairs for Pall Life Sciences and chairman of the Bio-Process Systems Alliance (BPSA) single-use biomanufacturing trade association. He has more than 32 years experience in the biotech and pharmaceutical industry.
Q: What are some of the industry publications you read and why?
I read a variety of journals in order to stay current on the biopharmaceutical industry. For the scientific component, I enjoy the Journal of Clinical Pharmacology & Therapeutics, Drug Information Journal, and the New England Journal of Medicine, to name just a few. Some of the financially focused periodicals I review include Forbes and Fast Company. With Life Science Leader, I like how the magazine applies lessons and experiences from leaders across the industry, as well as the breadth of stories and editorials. In all of the publications, I prefer excellent content which doesn’t have an obvious sales focus, and I personally don’t find publications which write about vendors/advertisers to be of much use.
Dr. John Hubbard is senior VP and worldwide head of development operations for Pfizer. In this position, he is responsible for global clinical trial management from Phase 1 to 4, which includes more than 700 clinical projects.