Worcester a knowledge center for single-use biologics?
Since insulin became the first treatment available in the 1970s, the biologics field has exploded.
Biologics, which are treatments derived from living cells, have become widely available in the last 25 years. But a new method of manufacturing these medicines, known as single-use technology, is revolutionizing the field across the globe and Worcester could become a hub for training and best practices for the companies that make them.
It began last year when research professor Kamal Rashid and others from WPI’s Biomanufacturing Education and Training Center (BETC) met with the head of a Pennsylvania pharmaceutical products company, AdvantaPure, to discuss how the center could help train employees on single-use technology, which is an alternative to the large, stainless steel vats that major biopharma companies typically use to make drugs.
That led to interactions with Bio-Process Systems Alliance (BPSA), an international trade group dedicated to the adoption of single-use manufacturing technology for biopharmaceuticals and vaccines. The group asked WPI to lead curriculum development for educational and training programs in order to establish industry standards and act as a training center for the single-use industry. A handful of other universities will likely be involved with establishing training centers too, and Rashid said BPSA is also hoping to find training partners in Europe and the Far East.
“They want to look globally … and establish training centers across the world,” Rashid said.
For its part, BETC has led WPI’s training programs for the biomanufacturing industry for the last three years, though WPI has offered this type of training since 2007. Programs include single-use manufacturing training, as well as training on stainless steel equipment.
Single-use improves feasibility
Because single-use technology is disposable, it doesn’t require the same cleaning and level of regulation under the Food and Drug Administration that stainless steel biomanufacturing equipment does, and a company can set up a single-use lab for a fraction of the cost of a traditional stainless steel lab, Rashid explained. That’s making it more feasible for companies to produce smaller batches of drugs for specific patient populations, and for companies in developing countries to afford the infrastructure necessary to produce biologic medicine.
GE leads single-use locally
But big players are interested in single-use technology as well. Kevin O’Sullivan, president and CEO of Worcester-based Massachusetts Biomedical Initiatives (MBI) noted that GE Healthcare Life Sciences, which is expected to open its new headquarters in Marlborough this summer, revolutionized the single-use technology market when it acquired Xcellerex, a Marlborough company that specialized in single-use biomanufacturing components, in 2012.
A proponent of Worcester as a center for small-batch biomanufacturing, O’Sullivan said he’s pleased that the BETC is “tapping into the training market” in the single-use industry through the alliance with the BPSA. He predicted that it will raise the city’s profile as a center of knowledge in this area.
“I just think the time is right for this,” O’Sullivan said.
Image source: Freedigitalphotos.net
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