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Sep 15, 2006 (Vol. 26, No. 16)

Driving Standards in Single-Use Disposables

Close Inspection of the Objectives of the Bio-Process Systems Alliance

  • Sometimes a technology is so obviously the right thing that it is hard to remember what it was like before the technology emerged. Single-use disposables for the bioprocessing industry is one such technology; the bioprocessing industry immediately recognized how disposables represented significant savings in time, labor, and capital. A scalable technology, single-use disposables flexibly increase production, eliminate CIP cleaning and validation and SIP sterilization, reduce the use of caustic chemicals and water for injection, and also reduce cross contamination.

    Is this technology, however, mature enough for the kinds of high-risk and high-cost processes biopharmaceutical companies face?

    The Bio-Process Systems Alliance (BPSA) was organized to meet the challenges of the emerging single-use bioprocessing industry. The association addresses the need to educate, standardize, and develop guidelines that safeguard the quality of drugs produced using this technology. The goal of the BPSA is to globally promote confidence in the application of single-use products in the biotech/pharmaceutical manufacturing industry.

    The founders of the BPSA recognized that a key to ensuring the successful adoption of single-use disposables was fully addressing customer needs across the entire range of single-use disposable products. All too often, emerging technologies are useful only in isolation and do not integrate well into an overall system environment. The BPSA recognizes that bioprocessing companies have an absolute requirement for integrated process solutions that cover media and buffer preparation to final fill.

    The alliance sought out the leading companies engaged in the manufacture and use of single-use bioprocessing products, bringing together the diverse know-how necessary for single-use bioprocessing. Members of the association range from manufacturers of plastic film, bags, bioreactors, filtration, to fittings and connection devices.

    An immediate benefit of the BPSA is the creation of a forum for the development of compatible technologies and standards to facilitate the use of disposables for pharmaceutical manufacturing. The first task of the BPSA is the development of guidelines and standards for the implementation, validation, and operation of single-use bioprocesses. Harmonizing these activities across manufacturers is key to ensuring that customers can have confidence in their entire single-use system. Easy? Hardly!

    The list of agencies and standards that could be applied to these products is daunting, and includes 21 CFR 177—Code of Federal Regulations, Association for the Advancement of Medical Instrumentation, American National Standards Institute, American Society of Mechanical Engineers, ASTM International, British Pharmacopoeia, European Pharmacopoeia, International Standardization Organization, International Safe Transit Association, Federal Test Method Standard, Japanese Pharmacopoeia, NIH, and the U.S. Pharmacopoeia.

    Since there are numerous products already in the marketplace, it should not be a surprise that there are a variety of guidelines and standards already in use.

    The BPSA also immediately identified that methods companies utilize in functional, physical, chemical, and biological testing may overlap and that more than one guideline or standard may be appropriate for a test method. It is also difficult to unequivocally state that a certain class of product should meet specific standards or be tested with a particular methodology. Additionally, some properties of products, such as the exclusion of animal derivatives, are properties of the plastic resin and not something that is verified by a device manufacturer.

  • Standards for Extractables and Leachables

    Identifying standards for extractables and leachables is another area of concentration for the BPSA. Extractables are substances that are obtained by applying a solvent or exposing a bioprocess container to conditions that are expected to be more aggressive than the conditions of contact between the container system and a relevant pharmaceutical solution. Leachables are substances that are present in the finished drug product because of the interaction with a bioprocess container system.

    The first task is simply to agree on the roles and responsibilities between suppliers of single-use bioprocessing products and the vendors of finished drug products.

    A solution is for bioprocess container systems manufacturers to provide vendors of finished drug products an extractables assessment of their system. Vendors of the drug product then supply regulators with a leachables assessment for their finished drug product.

    In the short run, the BPSA is focusing on continuing identification of commonalities of how single-use disposable products are developed and tested, reviewing the differences, recommending guidelines and standards as appropriate, and facilitating the acceptance of single-use technology by regulatory agencies.

    In the end, all of these efforts are directed to ensuring a well-designed, integrated disposables process for drug manufacturers by providing guidelines and recommendations for how to determine the suitability of single-use products for bioprocess manufacturing operations.



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