Engineering Angles: Balancing speed and safety

Nov. 23, 2020
A strong regulatory strategy can help ensure future rapid response

Can you have a regulatory strategy in place to accelerate drug development — without getting slowed down by compliance considerations?

The COVID-19 pandemic has created an inflection point between the need for speed and the need to protect patient safety. For this balancing act to succeed, drug developers need a detailed, forward-thinking regulatory strategy. With a strategy in place — and expert guidance to help put it into action — you will be able to improve response time in the face of unexpected health crises.

The lessons we learn today will reshape the pharma industry’s capability to respond more quickly and more safely. Building compliance strategy into ongoing operations will be essential to maximizing that capability. There are three components to a rapid, compliant response:

• Quickly pivoting between modalities as new health needs emerge
• Closing and automating processes for improved speed and quality control
• Identifying appropriate partners

Here’s how a regulatory strategy can help in each case:

Pivoting quickly

A true multi-modal facility meets the variable needs of carefully selected and highly compatible manufacturing processes, like viral vectors and monoclonal antibodies. Such suites are especially well-suited for developers with evolving pipelines and contract research organizations staying responsive to clients’ ever-changing needs.

By taking advantage of the manufacturing and regulatory similarities between products, operators can pivot a production suite much more quickly from one product to the other — sometimes within hours.

A consistent, well-defined process is at the heart of rapid changeover. This requires a deep understanding of the regulatory compatibility between products. A regulatory strategy enables you to design your multi-modal facility to remain continuously validated and compliant, even as various products move through the pipeline.

Closure and automation

The more humans you can remove from your process, the more you can reduce or eliminate the risks of contamination. That’s why closure and automation of processes is such a critical focus for multi-modal manufacturing.

Your approach to assessing risk and communicating with regulatory agencies is key to designing an initial process, applying a process across multiple modalities, and/or matching a process to the right facility. Showing that your products will be safe, and that you’ve taken all appropriate measures to design a process to make them safer, makes it easier to move more smoothly through the FDA approval process.

To prove that you are managing risks and are capable of producing reliable products, you need to demonstrate how you have integrated your process and facility design, and how you have implemented all necessary protocols. A regulatory strategy can help coordinate these complexities.

Identifying partners

Strategic partnerships are a popular way to move more efficiently through clinical trials and into full production. High-profile companies that are engaged in the COVID-19 response, such as partners BioNTech and Pfizer, are already doing this.

The movement towards a decentralized drug development process goes well beyond the research lifecycle, however. In many scenarios, multiple partners are linked to form an end-to-end commercial manufacturing process, from bulk production through distribution.

Of course, partnerships can be a risky business. You need to understand a potential partner’s capabilities, utilities and regulatory history. Do they have the right infrastructure in place? Will they be able to mobilize quickly? Is the partnership likely to produce a safe, consistent product according to regulatory criteria?

Partnerships must be evaluated continuously as a part of a product quality strategy. Guidance from knowledgeable experts is expected from the regulatory agency to thoroughly assess the quality and safety of a potential partner.

The long-term decisions we make as an industry will ensure rapid, flexible and safe response to any health threats waiting for us around the corner. The key to such decisions lies in a strong, proactive regulatory strategy. Such strategies across the industry will be instrumental to our future. 

About the Author

Christa Myers | Process Chemical Engineer