Vendor Partnering In A Bioprocess Manufacturing And Supply Chain Ecosystem

By Donnie Beers, Product Manager – Life Sciences, Entegris

Supply constancy, cost, sterility – even a subset of the factors that impact materials selection can present a daunting prospect for biopharmaceutical companies embarking on a new drug development project. These considerations, when coupled with the intersecting pressures that influence them, such as regulatory constraints, institutional inexperience, and long-term market outlooks, can drive many companies to default to traditional, industry-standard choices for their materials needs.

But the inclination to defer to “the old way” has the potential to create new problems in a paradigm beset by change. Many pharmaceutical companies can find themselves well into the drug development process before materials issues become apparent. Perhaps they have already filed an IND and begun producing drug substance, relying on materials chosen for their widespread use and longstanding market acceptance, only to encounter process challenges that force them to reevaluate parts of their supply chain.

As novel therapies produced and stored under extreme conditions become more common, containers that were adopted decades ago are increasingly unable to meet project needs and regulatory standards. One arena where this shift is becoming increasingly apparent is with multi-layer bag assemblies, which began to see increased use decades ago as a cost-effective alternative to constructing stainless steel facilities. These technologies, originally transferred from the food industry, are applicable for many projects, but that applicability is being tested every day by new production techniques involving new chemistries, wider operating temperature ranges, and increasingly complex and sensitive drug substances.

Of course, alternatives to these bag assemblies are available to meet the needs of more complex projects. New single-layer assemblies, made with more robust materials and without the curing agents, antioxidants, plasticizers, or adhesives that represent potential contamination sources, may offer companies a safer and more efficient choice. Identifying the need for these technologies and implementing them requires thorough validation and testing efforts. By partnering with the right vendor, companies can gain access to the expertise, partnerships, and innovations that will help them safeguard their treatments from development to commercialization and beyond.