Biopharma single-use producers form new trade alliance

Manufacturers in the growing market for single-use process components and systems within the biopharma industry have formed their own trade association. The aim of the alliance is to educate, standardise, and develop guidelines that safeguard the quality of drugs produced using this technology and so promote confidence in the application of single-use products in the biopharma sector.

"The Bio-Process Systems Alliance (BPSA) was organised to meet the challenges of the emerging single-use bioprocessing industry," said Chris Rombach, of Stedim, a BPSA spokesperson. "There is a great need to educate, standardise, and develop guidelines that safeguard the quality of drugs produced using this technology."

The alliance has been formed under The Society of the Plastics Industry (SPI), the umbrella organisation providing a unified voice for the diverse plastics industry.

"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," said Rombach.

William Carteaux, president of the SPI said: "The prospects for single-use growth are enormous. They are at the cutting edge of one of the fastest growing industries in the world".

At a recent meeting, Rick Sullivan of HyClone, a business unit of Fisher Biosciences, was elected chairman and Lisa Krallis-Nixon of Charter Medical was elected vice-chair. Ken Bibbo of Alfa Laval was elected secretary/treasurer and Don Jahn of Dow Corning was elected director-at-large.

Three key subcommittees were also established that reflect the new alliance's initial focus: Chris Rombach of Stedim was elected chair of the subcommittee on identity. Roberta Landon of Millipore Corporation was elected chair of the education subcommittee. Tom Murphy of TC-Tech and Dave Bacehowski of HyClone were elected co-chairs of the subcommittee on guidelines and standards.

The seven members listed above make up the new group's executive board.