Scaling Vaccine Production Process Development Best Practices | Corning

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The vaccine production process is continually refreshed by new tools and technologies. A process developed even a scant few years ago could now be woefully outdated.

That teeming innovation activity gives researchers numerous opportunities to adjust processes to achieve more cost-efficient or effective production scale up — something that's immensely helpful during the COVID-19 pandemic. But it also imposes challenges on process development scientists: They're the ones who have to align and optimize new methods and means with legacy products and systems. And that can keep a scientist on their toes.

Customization not only can make this process less difficult but is actually essential. Because no one vendor can provide a complete solution from research through production, customization is inevitable to ensure that products and technologies from different vendors work together properly. By carefully crafting a customized modular process from end to end, process development scientists can glean the benefits of new technologies without starting from scratch with each new iteration, says John Yoshi Shyu, Ph.D. Shyu oversees Corning Life Sciences field and internal scientists who optimize processes for customers looking to design or augment their production plans.

"Plug-and-play systems don't really happen in the vaccine world," Shyu said. "As new technologies come into the field, labs have the challenge of linking existing systems with new technologies. Integrating new technologies and techniques into established practices requires precise customization. Sometimes, that can lead to conflict, as people comfortable with the current process are challenged to adapt to new technology and procedures. And there's always time pressure."

How can researchers working on vaccine production optimize their process with customization in mind? Shyu has a few suggestions.

1. Find a supplier that offers field support.

Working with a supplier that offers technical support can provide labs with a fresh perspective on long-established practices. That outside opinion can help scientists navigate the challenges of process optimization and introducing, customizing, and troubleshooting new technologies to improve yield and reduce scale-up costs.

Corning offers support service from field application scientists as part of its suite of process products.

"We're here to help labs ensure that our products enhance their process in terms of technology as well as the applications, process and biology aspects," Shyu said.

2. Don't invest in improvements you don't need.

Not every lab needs the biggest and most sophisticated bioreactor or the latest technological marvel. Nor can every lab afford it — particularly smaller academic labs that are at the mercy of grant funding.

To help scope out your needs, Shyu suggests plotting out your short- and long-term therapeutic development objectives in consideration of your budget, then working with a vendor who can help you get the most bang for your buck. The first questions a vendor should ask, he says, include:

  • What is the level of scale you want to achieve?
  • When do you want to get there?
  • What's the status of your current technology and infrastructure?

"Sensible vendors will use those answers to find the most effective and most appropriate custom scenario," Shyu said. "We frequently suggest alternative strategies that will still get customers to a better place with less financial burden." For Corning field application scientists, the goal is customer success, not incremental sales. Customized alternative strategies can include buying less expensive equipment or designing-in big-ticket purchases by employing a modular approach.

3. Ensure that your supplier has life scientists on deck.

Engineers are critical to process development but so are life scientists. Working with a supplier that staffs your project with both can help ensure that the technology gets implemented properly and that it works toward your desired scientific outcomes such as keeping cell cultures alive and producing the desired product.

"Process development isn't just about deploying technologies for workflow optimization," Shyu said. "It's also about optimizing conditions for the actual scientific work. If your supplier only deploys an engineer to help, without additional support from someone with a strong biology background, you're going to miss out on that scientific component and the ability to troubleshoot potential problems encountered in production."

4. Go modular.

Creating a modular, scalable production suite can ensure that you get the best of both worlds: short-term cost control and the flexibility to add new technologies and adapt to new production needs as required.

That flexibility can make all the difference in any market, but particularly in one marked by constant change and stiff competition. By modularizing, you give your lab more muscle and the agility to adapt and respond to ebbs and flows in clinical demand.

"How do you adjust for potential market changes? You invest in technologies that allow for modular additions so that you can scale as and when you need to," Shyu said. "If you only need 100,000 doses per batch today but you need 200,000 doses per batch tomorrow, you can adjust your process without spending additional time investigating alternative technologies."

Shyu likens it to sets of building blocks: You may purchase a 100-piece set to build a ten-story building. Later, if you want to add two more floors, you can buy just the number of blocks you need, rather than having to invest in a new 10-story building. You can also decide on different configurations (e.g. two five-story buildings), as well as incorporate other types of blocks to leverage new designs and features.

It works the same way in bioprocess: The modular approach can help you avoid the upfront costs of a larger investment, while providing flexibility to add or accessorize as new products and technologies hit the market.

Customize and Adapt Your Process

Any lab of any size, with the help of the right partners, can customize its process so that it can incorporate future innovations — and in vaccine production, you never know when that next big thing could come along. By following these tips, you can scale your processes and goals without locking yourself into a legacy setup.