Coordination of Single-Use System Standards and Best-Practice Efforts

A BPI Theater Roundtable at Interphex 2016
On Tuesday, 26 April 2016, James D. Vogel (founder and director of The BioProcess Institute at the University of Rhode Island) chaired a midday roundtable titled, “Single-Use Harmonization Town Hall: Coordination of SUS Standards and Best Practice Efforts.” Two industry experts joined him in a panel discussion:

All three are members of different groups interested in developing standards for single-use technologies. Nicknamed “the alphabet-soup” groups, they include the BioProcess Systems Alliance (BPSA), BioPhorum Operations Group (BPOG), Parenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE), Single-Use Technical Assessment Program (SUTAP), American Society of Mechanical Engineers (ASME), BioPharma Engineering (BPE), United States Pharmacopeia (USP), and the American Society for Testing and Materials (ASTM).

Vogel said that standards organizations are looking for answers to the following questions: What are you interested in, and what can help the industry move forward? What standards and guidelines can help in single-use manufacturing? Where should we be in one year, five years, and 10 years?

Current estimates give the biopharmaceutical industry a US$200 billion potential. Single-use technology is now an accepted part of it. Some 80% of early clinical trial material manufacturing now involves single-use technology, and the market is growing rapidly. A multidisciplinary effort called Standards Boost Business (www.standardsboostbusiness.org) is emphasizing consensus-based standardization. Standards can help reduce qualification and validation costs, assist in development, and enable growth, and they are encouraged by regulatory agencies. Stating that voluntary standards are being followed can be helpful during inspections. It also is better for industries to create standards for themselves than to have regulators set them.

The “alphabet soup” groups are trying to foster a collaborative environment with monthly formal discussions. They began with a 2013 “town hall” in Boston sponsored by BioProcess International and has led to 10 more such panels since then. Now they produce a single-use technology newsletter online. Many working groups are active within different organizations looking at extractables, leachables, particulates, sampling processes, system integrity, methods for testing, connectors, supply chain activities (e.g., change notification), design verification of single-use assemblies, and biocompatibility studies (assessing toxicity within single-use assemblies).

Johnson and Carter added that standards will help groups collaborate and ease friction between competitors and among companies in the single-use supply chain.

Questions and Discussion

One participant said that a standard change-notification form alone would be very helpful. If all suppliers used the same form with the same information, then users could save time and know better where to look for information. Biopharmaceutical companies should have a single email address for receiving change notifications (as they do for accounts receivable) because it is not always clear to suppliers where to send them.

Another attendee asked about priorities. “Can you get more done with more people helping and joining committees?” The panel answered that groups want users to communicate their priorities. Carter and Johnson discussed how their groups set priorities. At BPSA, for example, a proposal is floated to determine who is interested in participating. If everyone wants to participate, then it gets a higher priority to be worked on. Sometimes only one or two people will volunteer to work on an issue. BPE has specific rules for introducing new standards. BPSA can quickly publish papers, which are sometimes incorporated by BPE. Alignment is needed between companies and regulators.

Discussion concluded with a request for new volunteers to join the groups. Panelists described the benefits of joining and invited participants to the next town hall at the BioProcess International Conference and Exhibition in October 2016, again in Boston. •

Alison Center is editorial assistant ([email protected]) for BioProcess International, PO Box 70, Dexter, OR 97431. Recordings of many of these full presentations are available online at www.bioprocessintl.com/Interphex2016