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Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.
Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems. “We are entering a new era,” commented Patrick Evrard, senior manager, single-use technology, at GlaxoSmithKline (GSK) Vaccines. He described how GSK used a single-use system (SUS) to speed production of a candidate vaccine against the Ebola virus to help control the outbreak.
Establishing a new bulk production process to obtain thousands of doses for widespread clinical trials was a “big challenge,” Evrard commented at the July 2015 annual single-use summit sponsored by the Bio-Process Systems Alliance (BPSA) in Washington, D.C. GSK formed a dedicated SUS team to manage the process and communicated early with suppliers about anticipated equipment needs before the production process was fully refined. The program was facilitated by minimizing customization, double-sourcing to obtain back-up solutions whenever possible, and utilizing in-house assembly capabilities to maximize flexibility.
GSK benefitted from experience gained in producing high volumes of flu vaccine in anticipation of a pandemic a few years ago, and in utilizing a disposable production system in upgrading bulk manufacturing of its polio vaccine at its Rixensart vaccine unit in Belgium. Those programs led to a set of company standards for re-design of a manufacturing process and for process evaluation, which could be applied to a disposable system, Evrard explained. He advised suppliers of disposable systems that biopharma “end users” need fast response to orders, full technological transparency in materials, and strong technical support, as well as greater attention to ensuring product reliability and quality.
A main concern of both suppliers and end users of disposable systems is to reduce the confusion and complexities related to the management of changes in materials and products. Although Evrard said somewhat facetiously that he would like 20 years of guaranteed supply, the reality of frequent upgrades and innovations in system components makes change management an important issue for all parties.
Biopharma manufacturers are particularly concerned about receiving hundreds of notifications about changes in the composition, shape, or size of system components, many with potentially low risk or impact. There is confusion over which kinds of component changes a supplier should tell end users, and what the drug manufacturer then has to report to FDA and other regulatory authorities.
To address these issues, BPSA members are working with biopharma manufacturers participating in the BioPhorum Operations Group (BPOG) to address change-order management, notification, and documentation. The aim is to establish standards for when such notification should be made and which parties should be notified. A draft proposal will seek to establish clear definitions, set tiers for major and minor change categories, provide a template for change notification, and encourage suppliers to identify a single point of contact who can provide information on product changes. The group plans to issue a white paper on how to streamline the change reporting process to ensure proper attention to more risky changes, and to map out opportunities for reducing notifications of routine changes that have little impact on end product quality.
BPOG is engaged in a number of initiatives related to adoption of single-use technologies, including the establishment of standardized extractables testing procedures to facilitate accurate assessment and comparison of single-use systems and components. More information is available at www.biophorum.com.