Best Practices for Achieving Virus Safety


The importance of collaboration in achieving virus safety assurance.

By Willem Kools, PhD., Head of Technology Management, Merck

To avoid production problems and potential supply delays, biopharmaceutical companies must be vigilant in all aspects of virus safety risk management. Regulations indicate that virus control should be employed at every stage of the manufacturing process. While it may feel overwhelming to design and validate layers of virus safety measures, partnering with Merck and the large network of technical experts at the M LabTM Collaboration Centers can make the difference between a proactive approach to virus risk mitigation using methods like Quality by Design (QbD) versus a more costly, time-consuming one that may leave patient safety at risk.

What’s the best approach for developing a virus safety process for biologics such as monoclonal antibodies (mAbs) and recombinant proteins? With its experienced BioReliance® team, Merck and the M LabTM Collaboration Centers rely on a three-pronged approach to virus safety.

• Firms can focus on preventing viruses from entering bioreactors by screening and carefully sourcing all raw materials (e.g., cell lines, buffers, and media) for potential contaminants and incorporating technologies to inactivate or remove potential virus contaminants with techniques such as UV-C inactivation and high-temperature short-time (HTST) treatment. Virus filtration of raw materials is another key prevention method.

• Virus testing is critical for determining levels of endogenous virus-like particles and for assessing if adventitious virus has contaminated the drug product.

• To eliminate any virus present in the process, manufacturers should employ virus removal and/or inactivation operations in downstream purification. This can involve a variety of methods such as chemical inactivation, chromatography, and virus filtration.

The Merck team has 30 years of experience working with customers on virus filtration in all phases of biopharmaceutical development. As these efforts evolved into comprehensive viral clearance testing and process development services, they saw the need to expand the opportunities for clients to work side by side with the technical experts at the M LabTM Collaboration Centers. Here, sponsors and the M Lab™ Collaboration Centers team can work on testing new products—both filtration, chromatography and new virus barrier technologies—as well as scale-up processes in a non-GMP and collaborative environment that inspires creative solutions.

Collaborative testing. The M Lab™ Collaboration Centers’ network of scientists and engineers work with clients to identify which product and service solutions or combinations would be best for their processes and help them implement a viral safety strategy with confidence. The open, collaborative atmosphere at M LabTM Collaboration Centers provides the flexibility to evaluate virus safety applications and processes that might not be possible in the client’s facility. In this “sandbox,” clients are free to collaborate and learn through hands-on and virtual experimentation. If a customer is facing a specific problem in their process, a suite of innovative digital tools and manufacturing equipment can help determine how to address it under representative process conditions. This scientific “playground” gives customers the freedom to explore without restrictions and sets the stage for a well thought-out and successful virus testing strategy. In addition, virus safety support offered at the M Lab™ Collaboration Centers is complemented by the biosafety testing and viral clearance services offered by Merck’s BioReliance® team.

Streamline strategies across production scales. Working with a knowledgeable partner to optimize virus safety solutions for biologics can also help streamline process scale-up as molecules mature. This is vital for keeping costs and timelines on track.
While a molecule is still in development, technical experts in the M LabTM Collaboration Center can run studies at both small and large scales to ensure the processes meet targets for purification and virus clearance. For instance, a group of technical experts worked with an early evaluator of a new virus barrier filter that wanted to know whether the technology would scale well as their molecule progressed through development and into commercialization. They mimicked the conditions of the customer’s plant in the M LabTM Collaboration Center and conducted a scalability study using the customer’s media. Doing that work up front, free from the bounds of SOPs and GMP requirements, was by far the easiest and fastest way for the client to generate reliable scalability data and perform both pilot-scale studies and large-scale operations.

QbD approach for increased efficiency. To bring virus safety to the next level, experts at the M LabTM Collaboration Center take a QbD approach to virus filtration processes. QbD can help teams understand the process, filter, and feed parameters that affect virus retention in order to develop a robust design space and parameter control strategy for virus filtration, which paves the way for process validation and regulatory approval.
The QbD approach used at Merck has numerous real-world benefits. One client, for instance, accelerated their development timelines enabling more-efficient filing of Biologics License Applications as a result of the streamlined process improvements. This is a huge advantage for biopharmaceutical companies that are often under intense time pressures to bring products to market as quickly as possible.

Creating and implementing a solid virus safety strategy for biologics is essential for all biopharmaceutical companies. Working with M LabTM Collaboration Centers not only gives companies access to cutting-edge solutions, but also provides a flexible environment conducive to problem solving and experimentation. Clients can try several solutions before committing to them and receive guidance from knowledgeable experts about the best approach for their project. The innovative tools at the M LabTM Collaboration Centers also help ensure processes scale well while a molecule is still in development, potentially cutting development time and costs. Last, the QbD approach that Merck applies to virus safety brings additional efficiencies. All told, extensive collaboration between sponsor and supplier not only simplifies the complicated process of establishing a virus safety strategy, but also adds numerous other cost and time-saving benefits to clients.

As seen in Biopharm International

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