Brewing breakthroughs: Harnessing large-scale fermentation for pharmaceutical products
Fermentation is a craft as old as bread and as innovative as the latest drug on the market. It's a method that's both time-honored and forward-thinking, often tapping into renewable resources and outperforming older synthesis techniques in efficiency. Microbial fermentation can be utilized to make a number of different product categories, including amino acids, complex natural compounds and lipid-based substances like fatty acids and sphingosines.
For over forty years, Evonik has been at the forefront of this field, empowering pharmaceutical companies with microbial fermentation capabilities. With a fermentation capacity of 4,000 m3 and facilities spread across the globe, we're equipped to take on projects of any size and intricacy.
In this interview, we talk to Colby Adolph, Director of Sales for the Health Solutions product line at Evonik, who sheds light on what sets a Contract Development and Manufacturing Organization (CDMO) fermentation manufacturer apart.
Q: What should customers expect from a top-tier CDMO in large-scale fermentation?
Colby Adolph: Customers are on the hunt for a CDMO that's not just experienced in fermentation and large-scale production, but also has a proven track record of delivering high-quality products. They need a partner with a robust understanding of regulatory guidelines and quality control and who can communicate clearly and pivot to meet evolving needs.
In an industry where processes are growing rapidly, companies also benefit from a CDMO that is able to join them along multiple phases of their growth cycle. Evonik supports companies from the strain development phase all the way through to large-scale commercial development, easing the complexities of working with multiple scale-up partners.
Q: How can customers ensure their commercial-scale fermentation campaign thrives?
Colby Adolph: Choosing the right CDMO is just the beginning. It’s important for both CDMO partner and customer to be aligned on the long-term vision of the project to ensure the day-to-day goals are aligned. Are there end-consumer deadlines? What registration limitations exist?
The goal is to be aware of how to position the customer for success so early alignment is important. Crafting a comprehensive plan with the CDMO's project management team is crucial, as is maintaining a laser focus on the project's objectives. Regularly checking on quality, costs, and progress is essential for a smooth transition to commercial production.
Q: What are the common hurdles in large-scale manufacturing?
Colby Adolph: There are many key pitfalls that customers need to look out for during large-scale manufacturing. First, chemical reactions can behave very differently at scale, so it is important to go in having a good understanding of the key process parameters and factors impact product quality. It will be important for the customer and CDMO technical teams to work closely together on what is known about the process and how it has been run so far.
We also have to consider process variability, which could lead to inconsistent product quality, effectively impacting product performance and quality. Temperature, pressure, oxygenation and ultimately titers can be greatly impacted by scale so it’s important to understand how these impact the process.
Other key considerations are the risk of contamination and equipment failure. Both could cause delays and negative impacts on quality, eventually adding to additional costs and supply chain issues.
Q: Why opt for Evonik's CDMO Fermentation services?
Colby Adolph: Decades of experience and a team brimming with expertise mean that Evonik can tailor solutions to your specific fermentation requirements. We're well-equipped to navigate any large-scale challenges or changes. Our facilities offer ample space for your processes, with the flexibility to grow as your ambitions do. From pilot stages to full-scale production, we help you manage everything seamlessly in one place.
Want to learn more about Evonik's capabilities for microbial fermentation or discuss your fermentation project with Colby? Get in touch with us!
