Tackling contamination risks successfully

peroxide vapour treatment is becoming increasingly recognised as an essential part of any contingency plan, explains Dr. Richard Lucas.

What are the main areas of contamination in the pharmaceutical manufacturing phase?

Richard Lucas. The shift towards biopharmaceuticals as the mainstay of modern drug development has increased the risk of contamination to a process. 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. 

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.

The recent example of a Vesivirus 2117 viral contamination in a large manufacturing facility's bioreactors, and the subsequent impact on drug production and regulatory concerns, highlights the potential impact of a contamination event.

To what extent has technology helped eradicate problematic bacteria and viruses throughout the development and manufacturing process?

RL. The use of facility and process-compatible hydrogen peroxide vapour (HPV) for example, allows regular bio-decontamination cycles to be performed in order to manage the risk of contamination while preventing lengthy and costly facility 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. HPV is an effective bio-decontamination process for isolated manufacturing lines without the need for disassembly through to complete facilities with minimal preparation.

Advances in materials transfer technology, such as the HPV transfer solutions developed by Bioquell, represent an important innovation in eradicating the risk of transferring contaminants into and out of clean and aseptic zones through rapid, validated and reliable bio-decontamination. HPV-enabled materials transfer allows rapid movement of tools components, consumables and even sensitive biological products themselves whilst maintaining efficient process flow and offering secure management of contamination risk.

Additionally, cross contamination of a facility or manufacturing line (for example with viral material) is an area of interest to manufacturers with a need to ensure batch-to-batch and campaign integrity.

Are current decontamination techniques sufficient to battle future issues of contamination?

RL. Techniques such as spray and wipe or mop and bucket methods appear to be under increasing regulatory scrutiny as the ability to validate and accurately monitor these inherently manual processes comes under challenge.

Validated solutions are required that are amenable to process requirements, and that offer the complete process control and operator safety that manual methods cannot. Bioquell’s HPV solutions represent an increasing share of the bio-decontamination market, replacing outmoded manual methods.

The high operating costs of a modern biopharmaceutical facility means that it is crucial to maximise manufacturing capacity. HPV offers key efficiency gains, minimising downtime during routine shutdowns and campaign changes as well as allowing better management of the risk of contamination during these periods.

What path do you see the future innovation of decontamination techniques and technology taking?

RL. The industry must maintain pace with the demands of the fast developing biopharmaceutical sector. Efficacy, safety and efficiency remain of paramount importance. 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.

Bioquell is an international business committed to high-level R&D investment in order to support the biopharmaceutical industry. We offer bio-decontamination solutions that manage contamination risk, improve process efficiency and easily integrate into current and future workflows.

The acceptance that personalised medicine is of growing importance may require considerably different manufacturing and patient delivery methodologies. Consultation with industry thought leaders will be vital to ensure this key enabling technology is available in a manner appropriate to new challenges.

Biography

In his role with Bioquell as a Biopharmaceutical Process Specialist, Richard Lucas investigates the application and integration of Bioquell’s novel decontamination technology in biopharmaceutical production environments.  As part of his role he liaises with thought leaders from both academia and industry to ensure Bioquell innovates to support future areas of development and manufacturing.