Single-use Technology: Balancing the Risks and Rewards

Developing a quality agreement template for single-use systems.
Sep 02, 2011

Single-use systems are being used more and more in manufacturing. The time savings, reduced incidence of cross-contamination, reduced need for cleaning, and increased overall efficiency, to name a few advantages, make these technologies a very attractive proposition for manufacturers. There are, however, several obstacles to implementing the single-use systems; a key obstacle being manufacturers' unwillingness to replace fully installed and validated technologies, while the lack of clarity in understanding the regulatory requirements for single-use technology presents another barrier.

Notwithstanding the potential hurdles, a recent poll of Pharmaceutical Technology readers confirmed that the majority of companies (56%) are already using single-use technologies. Of the remaining respondents, 18% admitted that they planned to use single-use technology in the future (1). So it is clear that, not only is single-use here to stay, but it could fully replace certain stainless-steel technologies in the future.

The development of quality agreements between biopharmaceutical companies and contract manufacturers has long been recognized as a critical activity to ensure that a product's quality meets regulatory requirements. Quality agreements are used to clearly establish each party's responsibilities and assure that manufacturing processes are controlled according to mutual understanding. For outsourced biological products, this is supported by the 2008 FDA Guidance, Cooperative Manufacturing Arrangements for Licensed Biologics. More recently, biopharmaceutical companies have looked to establish quality agreements with raw material and API suppliers as a means to guard the supply chain from counterfeit or adulterated materials. This drive has led to the recent publication of a Quality Agreement Template for API manufacturers by the Bulk Pharmaceutical Task Force (BPTF), an affiliate of the Society for Chemical Manufacturers and Affiliates (SOCMA).

Considering the increased reliance that singleuse manufacturing technology places on suppliers to ensure biopharmaceutical quality, quality agreements have also begun to be established between singleuse process equipment suppliers and users—particularly for critical singleuse equipment, such as filters, biocontainers, tubing manifolds, and other integrated singleuse systems. While some companies have negotiated agreements on a casebycase basis, there is a recognized need within the industry for a common quality agreement template (QAT) specific to single-use manufacturing that highlights key performance criteria. With this in mind, the BioProcess Systems Alliance (BPSA), also an affiliate of SOCMA, has formed a Quality Agreement Template Task Force (QATTF) to develop a suitable template for singleuse technologies for the benefit of users and suppliers.

BPSA is an industry trade organization for suppliers and users of singleuse technologies for production of biopharmaceuticals and vaccines. Its primary objective is to facilitate the implementation of singleuse manufacturing through networking, recognition, and publication of best-practice guides, to provide clarification of current regulatory requirements, and to interact with governmental agencies on emerging issues that may impact BPSA members. The BPSA QATTF is composed of quality department personnel from member companies that are system suppliers and end users. This is a global initiative because many BPSA member participants on the committee represent global companies.

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