Overcoming challenges in raw material variability
To take its biopharma ingredient portfolio to the next level, BASF is working with customers and the industry to find solutions for raw material variability.
InFocus
Overcoming challenges in raw material variability
To take its biopharma ingredient portfolio to the next level, BASF is working with customers and the industry to find solutions for raw material variability.
Meike Roskamp
Controlling variability
Encompassing everything from the formulation of proteins, vaccines, and antibodies to cell and gene therapy, biopharma is a transformative space.
Active pharmaceutical ingredient (API) production relies on raw materials that are sometimes inconsistent, whether due to diverging chemical or physical characteristics, additional contaminants or impurities, or missing components.
“This inconsistency can cause variability in performance of a raw material in production,” says Meike Roskamp, Head of Business Management Biopharma at BASF. “That leads to process inconsistency, yield loss, and even affects the characteristics and quality of drug products, which can impact its safety, stability, and efficacy.”
Over the years, as the industry has continued to evolve, so have these variability challenges. For instance, processes like intensified bioprocessing seek to challenge the limits of established manufacturing concepts, while also stretching the performance of available ingredients to its limit.
The pharma industry has recognized the importance of raw material consistency and efforts have been made to better understand the requirements for raw materials in bioprocessing. Biopharma manufacturers and others that participate in the value chain are constantly looking for raw materials that fit new processes and prioritize consistency so they can minimize risk and ensure consistent yield, quality, and efficacy. As a result, raw material suppliers have also started developing application-specific products for the biopharma industry, which reduces the risk of performance variations.
Different from standard processes
Unlike standard small molecule pharma processes, biopharma processes rely on live cell systems to manufacture the target antibodies and proteins that serve as the API of a biological formulation.
“Both the manufacturing processes as well as the API itself are highly complex and therefore particularly sensitive to raw material variability,” Roskamp continues. “Small variations in the chemical composition of a raw material can lead to a significant reduction in protein yield, for example. Because of the high number of raw materials involved in the manufacturing process, it can be challenging to find the root cause if a problem occurs.”
Despite their complexity and the fact that biopharma is not an established process that’s been running for decades, Roskamp says it’s an exciting time for biopharma. “So far, it’s been about identifying the processes and making them work. Now, it’s about moving from making them work to optimizing them.” As knowledge of bioprocesses is better understood, Roskamp explains how it’s now possible to define more precisely the required specifications and develop application-specific materials. “Another important solution is a closer exchange and collaboration between the raw material supplier and the biopharma companies,” she says.
A dependable partner
As a company that values strong collaborations between its science and its customers, BASF is committed to generating value at every step of the chain.
Roskamp shares how BASF is “investing in an additional good manufacturing practice (GMP) production site for poloxamers. This won’t just serve as a back-up site for existing products but allows us to make application-specific poloxamers with a very reproducible chemical composition; something we believe has the potential to improve the reproducibility and performance of biopharma processes.”
Another important point is BASF’s commitment to tracking industry challenges so it can continuously exercise its chemistry leadership by expanding its biopharma ingredient portfolio.
“We work closely with our customers and are looking for opportunities where we can use our chemistry expertise to find innovative solutions for the biopharma industry that can make existing processes more robust, improve efficiency, and support the next generation of processes,” Roskamp says. In short, it comes down to BASF being chemistry experts.
With a central research and development team that works on surfactants for all kinds of industrial applications and the analytical techniques required to characterize surfactants and investigate properties that might be causing problems in complex applications, they can tailor product specifications, reduce the risk of performance variability, and support customers with troubleshooting and optimization.
“By applying our chemistry expertise, we can solve biopharma problems,” Roskamp says. “Using the intersection between disciplines, we can find innovative solutions that support the biopharma industry. We have a combination of research and development but also production capabilities to address application-specific materials.”
For more on how BASF’s growing biopharma portfolio and how our team of chemistry experts can become a dependable partner, reach out and start a conversation today.
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