New Conference Aims To Bridge Single-Use's Most Crucial Gap
By Trisha Gladd, Editor, Life Science Connect
No one can deny that there are benefits to using single-use technology (SUT). While it might not be a fit for every business plan, it certainly offers those who use it the ability to increase flexibility and lower costs. However, there are still several challenges with its implementation that need to be addressed before we can see an increase in adoption.
One of these risks is the effects of extractables and leachables from disposable equipment as well as the lack of standardization in extractable testing. When we talk about this problem at conferences, it is usually a discussion between SUT suppliers and end users. To come up with an effective solution though, it’s going to require going back to the basics of science with all of the major players in one room. These aren’t just suppliers, end users, and academia but also those suppliers in the process that are often overlooked, such as the resin manufacturers, film extruders, and gamma radiation experts.
This is the plan Ekta Majahan, senior process development engineer at Genentech, had in mind when she submitted a conference proposal to the Engineering Conferences International (ECI) Conferences Committee. “Plastics are something that has been used in the food and medical device industries for many years,” she explains. “The same principles used for providing plastic to those industries could apply to biopharma, but there are differences in the requirements. We need to learn and leverage the experiences and growing pains from implementation of plastics in other industries. The conference, titled Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications, has since been approved and is scheduled for October 18th to the 21st in Leesburg, VA.
Lack Of Communication Creates Barriers For Adoption
Increasing collaboration and understanding among these different groups is key. For end users, it’s important they understand what kind of challenges or limitations there can be on the supplier side. For suppliers, they need to understand why the biopharma industry is asking for what they’re asking and how it’s different from the other industries that they have been supplying with plastics, such as the food industry. They also have to make sure their products are where the biopharma industry needs them to be, from a GMP perspective.
“The hope is to bridge that gap between the different technical teams of experts involved in single use, and truly take it back to the polymer science. We should think about, ‘Okay, if we make any changes or use it for a new application, what impact does it have on bioprocessing?’” says Mahajan. In the synopsis on the conference website, she and co-chair Gary Lye (University College London) recognize the challenges faced by everyone involved in the process and the lack of communication among the various groups. “The purpose of this conference is to delve into the science of polymers as it applies to bioprocessing and bring the various technical groups to one common venue to share their issues, understanding, and solutions,” she says. “The aim is for manufacturers to understand how their products get used in bioprocessing and the impact that their formulation, processing conditions, assembly, etc. has on bioprocessing. Similarly it allows the biopharma industry to understand the challenges, limitations, and what is involved in film and other SU component manufacturing.” The conference also has speakers and attendees from academia to supplement industrial research in this area. None of the sessions planned overlap, so attendees will not miss topics, such as “Properties of a Good Plastic,” “The Infamous Extractables/Leachables,” “Interaction of Plastic with Cells/Proteins,” and they keynote session, “Single Use Polymeric Materials: The Science of Safety.”
Overcoming the challenge of extractables and leachables, increasing flexibility and understanding physical/mechanical characteristics would be major steps for the implementation of single-use technology. However, this requires single-use equipment suppliers to provide better data. “There are some [suppliers] who try to understand their supply chain better and try to understand the resin, but that’s not true for all the suppliers. “All suppliers have to be knowledgeable about how the extractables could interact with our cells and proteins. I think that’s one of the fears that people have. That’s one of the first questions you get, as soon as you propose single use for any project. In order to make single use truly flexible and valuable to use, we need to invest the time and attention necessary to make sure those promises are valid.”
To see complete details about the conference, including the program listing all the speakers and topics, visit the conference web site: www.engconf.org/15aj.