Worcester Polytechnic Institute (WPI) is the first academic institution to join the Bio-Process Systems Alliance (BPSA), a trade association dedicated to encouraging the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. WPI will help the international industry group develop curriculum frameworks for educational and training programs for these technologies, which are transforming the biomanufacturing industry.
"Biologic drugs and vaccines are the future of human therapeutics, and single-use technologies are changing the way these products are manufactured," said Kamal Rashid, PhD, director of the Biomanufacturing Education and Training Center (BETC) and research professor at WPI. "We have integrated single-use technologies at our center, and we see the need to build consensus around best practices, curriculum content, and learning outcomes for training people to work in a single-use biomanufacturing environment. We look forward to working with the members of BPSA to begin this important process."
WPI's BETC is a bench- to pilot-scale biomanufacturing center established to expand and develop the qualified workforce available to biomanufacturers. The BETC also helps companies limit their risks and comply with FDA guidelines by training, and retraining, their employees at a state-of-the-art center that is removed from their own production facilities. The center also offers a range of consulting services to help biotechnology companies manage challenges or institute best practices in their operations.
Rashid and Daniel Mardirosian, senior operations manager at the BETC, are members of the planning team for the BPSA International Single-Use Summit, to be held July 13–15 in Washington, D.C. Sessions at the summit will focus on the educational needs of the industry and the sustainability of single-use biomanufacturing.
"BPSA is thrilled that WPI has chosen to partner with us to elevate this discussion and focus on comprehensive worker training for our industry," said Kevin Ott, executive director of BPSA. "Qualified and trained workers are the lifeblood of our businesses. Nothing is more essential to the manufacture of innovative therapeutics and vaccines that may employ single-use systems than skilled workers whose degrees and training are relevant and focus on the safety and efficacy of single-use systems."
Biologics, such as insulin, are drugs made in living cells and represent the fastest growing segment of the human therapeutics industry. Traditional biomanufacturing is done in stainless steel and glass equipment—connected by rigid pipes—installed in fixed manufacturing suites. Emerging single-use technologies use engineered disposable plastic bags, tubing, aseptic connectors, and sensors to replace stainless steel and glass in nearly all elements of the biomanufacturing process. Single-use technologies lower the capital costs of building a biomanufacturing plant and enable more flexible manufacturing environments, making it easier to produce multiple products in the same facility.
"Single-use fundamentally changes the biomanufacturing environment. It’s not a trivial change," Rashid said. "There is great potential here to expand biomanufacturing and make biologic drugs accessible to more people around the world. At the same time, companies and regulators need to consider how education and training programs should evolve to match the technological advances. That’s the goal of our new collaboration with the BPSA."
About the BPSA
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led corporate member trade association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its member company employees. For more information about BPSA, visit www.bpsalliance.org.