Manufacturers of single-use process components and systems within the biopharma industry in the US have launched a new alliance at Interphex to educate, standardise, and develop guidelines that safeguard the quality of drugs produced using their technology.
The Bio-Process Systems Alliance (BPSA) was formed under the Society of the Plastics Industry (SPI), an umbrella organization providing a unified voice for the diverse plastics industry, to give greater visibility and more effectiveness in promoting the benefits of single-use manufacturing.
"BPSA was organized to meet the challenges of the emerging single-use bioprocessing industry," said Chris Rombach, a BPSA spokesperson.
"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."
The primary objectives of BPSA are to grow the market nationally and internationally by facilitating adoption of single-use components and systems, establish guidelines and standards for the use and disposal of single-use process components and systems, and educate customers, regulatory bodies and non-government organizations on the benefits of using single-use systems.
The alliance aspires to bring together the diverse know-how necessary for single-use bioprocessing, ranging from manufacturers of plastic film, bags, bioreactors, filtration, to fittings and connection devices.
"The prospects for single-use growth are enormous," said SPI president William Carteaux.
"They are at the cutting edge of one of the fastest growing industries in the world and this is a win-win situation for SPI and for the Alliance."
The growing use of single-use bioprocessing is due to the many advantages disposables offer over traditional glass and stainless-steel equipment.
Some of the benefits include lower capital cost, minimal cleaning expenses, reduced steam-in-place/autoclaving and decreased validation costs.
It also offers rapid deployment thanks to faster equipment delivery and commissioning, swift batch/product changeover, lower contamination rate and less chance of an operator error.
More information about the Bio-Process Systems Alliance (BPSA) can be found on the new organisation's >website .