Guest blog by Jerold Martin, senior vice-president of Global Scientific Affairs at Pall Life Sciences
PDA held a successful workshop earlier this spring in Phoenix for over 100 attendees on key elements of the association’s forthcoming Technical Report on Single-use. An important discussion topic was the need for a transparent partnership between the single-use system supplier and the end user. The degree to which the user is dependent on the supplier is significantly greater than for traditional materials. Suppliers must become an integral part of the user’s quality system, which requires unprecedented levels of transparency, data sharing, and management. This issue will be a significant challenge for suppliers and users. However, as stated by Duncan Low of Amgen, “Those who fully embrace true partnerships will be the most successful.”
Tor Graberg, Chair of PIC/S and Head of Sweden’s Inspection, Medical Products Agency (MPA), provided a favorable European regulatory view to single-use manufacturing. In his talk, he stressed the concept of “documented trust” between supplier and end-user to construct a robust information bridge, particularly in the areas of quality and change control.
A third key point expressed during the meeting was the need for ongoing operator training programs in the handling of single-use biocontainers for media, bioreactors, buffers, intermediates, and final products. Russell Wong of Bayer Healthcare spoke of Bayer’s awareness training, which is held twice a year on bag handling to train everyone on the handling of single-use biocontainers—including the plant’s fork lift driver.
I had the privilege of speaking on two topics—current trends in extractables and leachables (E&L) testing, and business models for single-use. New applications of single-use technologies in final drug product formulation and filling have heightened requirements to ensure patient safety compared with established API applications of single-use for media and buffer preparation and storage, bioreactors, and intermediate–bulk API storage. Although new to bioprocess developers, these requirements are well understood by formulation experts who currently conduct E&L studies for final container-closure systems. The safety risks of leachables from single-use filters, tubing, and biocontainers in final formulation and filling are generally low because of short contact times, lower temperatures, and lower surface-area-to-volume ratios compared with final dosage containers. However, a safety assessment must still be conducted and submitted in regulatory filings.
Business models for single-use manufacturing are an untraditional topic for a PDA meeting, which otherwise tends to focus on more technical manufacturing, quality, and regulatory issues. However, single-use is such a significant change in manufacturing paradigm that process development, quality assurance. and facility design engineers are often challenged to justify the implementation of disposable systems from an economical perspective, as well as a technical and regulatory view. Chris Smalley of Merck and Co. brought these economic principles into focus with an informative presentation on how Merck conducted an economic comparison between stainless-steel and single-use systems for the manufacture of a bulk vaccine.
The PDA Technical Report is expected to be published by this coming fall, and will offer a basic primer on the economic factors that go into the decision to implement single-use manufacturing that will provide the reader will an expanded sense of their role in the decision process.
BPSA to hold open user–supplier summit
BPSA will hold its 2nd International Single-Use Summit in Washington, DC, July 23–25, 2012. The event is open to all interested participants (BPSA corporate membership is not required) and the BPSA has organized a line-up of expert speakers to provide perspectives on future pharmaceutical markets and the role single-use technologies will play in fulfilling goals for better, faster, more cost-effective therapies. Confirmed speakers include Ken Gronbach, a noted national demographer and author, on global population trends and how they will impact health-care requirements; ABC News senior correspondent Jonathan Karl on the upcoming Supreme Court decision on the Affordable Care Act (otherwise known as ‘Obamacare’); Kim C. Bush of the Bill & Melinda Gates Foundation (Director, Life Sciences Partnership for Global Health) on the foundation’s mission and actions; and biotechnology strategist Eric Langer of BioPlan Associates, on the current growth and demand for single-use systems.
Single-use adopters (and BPSA corporate members) Merck, Shire, and Catalent will also share user perspectives on the role of single-use manufacturing in drug development, global vaccine acceleration and delivery challenges, as well as perspectives on the pan-global adoption of single-use as an enabler for quick and effective manufacturing. Several panels and networking sessions are planned to facilitate interactions between current and future users and supplier experts on the current challenges and solutions to implementing of single-use technologies in biomanufacturing.
The event will be held at the Four Seasons Hotel, Georgetown, in Washington, D.C. The full agenda and registration information can be viewed at