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The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers

By: James Zoshak

The COVID-19 pandemic has added increased risk and uncertainty to gene therapy supply chains. To mitigate this risk, it is critical for biopharmaceutical manufacturers to properly maintain the documentation governing their continuity of operations.

It’s complicated: Gene therapy products supply chains and manufacturing

While many people working in the pharmaceutical industry can reduce their risk of COVID-19 infection by working from home, remote work isn’t an option for our colleagues on the manufacturing floor and in transportation logistics. When these experts become ill or are quarantined, the effect on supply chains is multiplicative. The more complex the supply chain, the more people are needed to manage them. So, it’s no surprise that the pandemic can negatively affect biopharma companies the most.

The manufacturing processes required for gene therapy products is much more complex than for small-molecule drugs. The rigor sufficient for the compounding and pressing of a small-molecule tablet won’t fly for the culture and harvest of a viral vector. Supply chain redundancy— investing in forecasting and establishing suppliers and production facilities in diverse global regions— has always been a good idea. But how realistic is it for the sort of cutting-edge facilities and processes required to produce quality gene therapeutics?

Manufacturing resources diverted to vaccine production

Recently approved COVID-19 vaccines, mRNA and otherwise, also create risks to gene therapy supply chains. Diversion of manufacturing resources to accelerate vaccine production has depressed the resources available for producing new gene therapies. Drug shortage across all therapeutic areas has been slowly worsening throughout 2020, and the trend has yet to reverse.

Staying cool is harder than ever

Many gene therapy products require cryogenic shipping and storage. The pandemic has made the availability of cryogenics such as dry ice a concern. The US has had a carbon dioxide shortage since the early days of the pandemic. Now that industry and consumer activity is beginning to ramp up, this increased demand is taxing a carbon dioxide supply that was barely keeping up with reduced demand. If you have a product that depends on a cold chain, I recommend familiarizing yourself with the economics associated with carbon dioxide capture.

The effect of the pandemic on regulatory agencies

The pandemic has also created new challenges for world’s health agencies: how do they to audit and inspect manufacturing facilities without putting their personnel at risk? Indeed, how do they address the increased load of regulatory filings for products to treat COVID-19 while keeping up with the anticipated filings for 2021?

The FDA’s pivot toward more stringent data requirements for gene therapy applications this year is certainly not independent of the considerations of the pandemic. The agency wants to be sure they are only approving products that provide a reasonable risk-benefit profile for patients.

Best practices for ensuring continuity of operations

One of the most efficient options for gene therapy manufacturers to mitigate supply chain risk is ensuring that their continuity of operations plans are updated, maintained, and followed. If there are events outside of your control, control what you can to minimize disruption to operations. Standard Operating Protocols (SOPs) for disaster preparedness, employee hygiene, and sanitation are as relevant to the gene therapy industry as they have always been to pharmaceuticals.

Unfortunately, these critical documents often aren’t reviewed and updated on a regular basis because other drug development activities are given higher priority. Yet how much time and money could you lose in a crisis due to the disruption of basic operating procedures? Sometimes, an ounce of prevention is worth a pound of cure.

To learn more about how you can de-risk your gene therapy program, please visit this webpage.


About the Author

James Zoshak is currently an associate principal regulatory writer at Certara. He is an experienced and detail-oriented chemistry, manufacturing, and controls (CMC) regulatory project manager, writer, and editor, with more than 14 years of experience. In his role, he plans, organizes, writes, reviews, and edits CMC regulatory submissions and other relevant documentation in support of the registration of numerous small molecule, biopharmaceutical, and gene therapy products marketed across the globe. In addition to his other responsibilities, he worked on-site as the primary liaison to one of Synchrogenix’s largest clients for ten years.

About the author

By: James Zoshak

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