Mitigating the Risks of Contamination in Biopharma
A crucial consideration in any pharmaceutical manufacturing process, and particularly when work involves biological elements, is how to mitigate the risk of contamination. Experts predict that within five years, the global biologics market will exceed $239 billion (£145 billion) in value, but there are just a few critical areas that threaten to hold developers back. Mitigation of risks arising from the contamination of adventitious agents is one such area of which knowledge is distinctly limited.
It is an issue that has been brought to light several times in recent years, by a number of high-profile cases involving big pharma. In June 2009, Genzyme identified a contamination at its Allston Landon manufacturing facility. Vesivirus 2117 was detected in one of six bioreactors being used and appeared to have restricted cell growth. The firm said at the time that steps had been taken to "increase the robustness" of its screening and removal processes. A similar situation arose at GlaxoSmithKline (GSK) last year.
Recent research conducted by Pharma IQ, ahead of an Ensuring Adventitious Agent Safety in Biologics event this week, revealed that almost two-thirds of producers do indeed have strategies in place to mitigate the risks of contamination. In a recent interview with Next Generation Pharmaceutical (NGP), Richard Lucas, a biopharmaceutical process specialist with Bioquell, said hydrogen peroxide vapour (HPV) treatment was increasingly being recognised as an important part of contingency planning for many firms.
According to Mr Lucas, the risk of contamination has been increased by the shift towards biopharma as the mainstay of modern drug development. "This is due to a more biologically accommodating environment inherent to these processes, the need for additional aseptic processing – for example virus removal, diafiltration or centrifugation, and frequent sampling," he explained.
Mr Lucas added: "Unfortunately, every additional process step presents an additional contamination risk. This is commonly through introduction via operators, materials movement or other process interventions, which create risk of contamination from the background environment." He went on to highlight the Vesivirus 2117 example at Genzyme, which had subsequent effects on drug production and regulatory concerns. It clearly highlights the potential impact of a contamination event, he added.
In terms of how technology has helped remove problematic bacteria and viruses from the development process, Mr Lucas highlighted the use of HPV as one example of how bio-decontamination cycles can be performed in a bid to manage the risks while preventing expensive downtime.
"The non-residual nature of HPV and the regulatory acceptance of the process as a means of bio-decontamination has allowed the rapid and effective bio-decontamination of complex process equipment. This includes, for example, freeze driers and incubators, as well as other large components that have been previously challenged due to the limitations of manual cleaning or requirements for disassembly, autoclave and reassembly," he told NGP.
In Mr Lucas's view, HPV can be an effective bio-decontamination process for isolated manufacturing lines without the need for disassembly. He believes that advances in materials transfer technology represent a vital innovation in ultimately removing the risk of transferring contaminants altogether.
As the demands of the fast-developing biopharma industry keep changing, the innovation in decontamination strategies will need to maintain pace. But as Mr Lucas pointed out, efficacy, safety and efficiency must remain the focus of any new technique. He concluded: "It is critical that bio-decontamination technology meets the needs of an increasingly diverse range of biotechnology processes ensuring controlled, validated bio-decontamination methods that help minimise the risk of process compromise due to contamination."