INDUSTRY NEWS
Single-Use Industry Creates Alliance
Manufacturers of single-use process components and systems for biopharmaceuticals have united in order to address the needs of the industry. Formed under the umbrella of the Society of the Plastics Industry (SPI), the Bio-Process Systems Alliance (BPSA; Washington, DC) strives to promote growth and confidence in the single-use industry.
Comprised of companies rooted in the expanding field, the BPSA serves as a pool of knowledge for the processing of single-use devices such as plastic film, filters, and connectors. With these resources, the organization hopes to provide a forum for the development and enhancement of disposables. Moreover, the alliance aims to channel this industry experience into the education of customers, regulatory agencies, and nongovernment bodies.
“BPSA was organized to meet the challenges of the emerging single-use bioprocessing industry,” says Chris Rombach, a BPSA spokesperson. “There is a great need to educate, standardize, and develop guidelines that safeguard the quality of drugs using this technology.”
As Rombach notes, another objective of the group is to facilitate the standardization of the burgeoning industry. Owing to the emerging demand for and interest in single-use devices, processes and guidelines must be established in order to ensure a seamless transition, according to the organization. The alliance also intends to play an integral role in encouraging the acceptance of single-use technology by regulatory agencies.
Despite the ambition of the group, it is undertaking some daunting tasks. Luckily, the group has built-in support. “SPI will give us the help we need to develop appropriate codes and standards, as well as provide expertise in legal and regulatory issues, marketing, and promotion,” Rombach says.
In generating interest for single-use products, the alliance highlights their benefits over glass and stainless-steel equipment. Among the advantages are cost-effectiveness, rapid deployment, and reduced utilities and environmental impact, according to the BPSA.
Rick Sullivan of HyClone (Logan, UT) will serve as chairman of the alliance. Members of the BPSA include Colder Products, Millipore Corp., and Saint Gobain Performance Polymers.Copyright ©2006 Medical Product Manufacturing News
