Thanks to new growth and drug modalities, customization has become increasingly important in maximizing output and saving costs. Now, through a co-creation process, BASF is helping its customers stay one step ahead.
Thanks to new growth and drug modalities, customization has become increasingly important in maximizing output and saving costs. Now, through a co-creation process, BASF is helping its customers stay one step ahead.
Customization is an important part of biopharma development. By helping customers optimize their processes around the cells they have and equipment they’ve chosen, it can lead to an increase in productivity and a reduction of risk, which can translate to significant cost savings.
“In many cases, ingredients used to grow cells are ingredients somebody had on the shelf, put in the media that worked, and nobody stopped long enough to check why it works and how it works,” says Nadya Morales-Cummings, Global Technical Marketing Manager, Biopharma Ingredients.
“As we progress and make changes in the way we make these kinds of medicines, we figured out that knowing a little more about the ingredients we put in the media and how they work can improve performance.”
It’s also important as technology continues to develop. With new modifications to existing manufacturing modalities, like perfusion or hybrid perfusion-batch systems, cell systems and supporting media need to be customized to meet those new needs.
Phil Butler, Technical Manager, Biopharma Ingredients, says “it’s about implementing process improvements like continuous processing and intensification through perfusion and technology challenges in cell and gene therapy that people are working out. As they do, they’re coming up with more customized options to solve problems they hadn’t thought about because it’s still such a new space.”
It’s this process that helped with BASF’s poloxamers, which are primarily used for shear protection and final formulation of antibodies
“Customers were experiencing poloxamer lot variability which would impact their yields,” Morales-Cummings continues. “We fixed that problem, but new details have come up that have allowed us to better understand how poloxamers work and how we can help customers using new processing modalities. They’re evolving their modalities and we’re evolving our raw materials to meet those new needs.”
Naturally, customization is focused on the initial upstream part of the process. “We’ve come to learn, and our customers are learning, that modulating the raw materials you use in that part pretty much determine its success,” says Morales-Cummings. “Most of those changes are happening in the upstream part of the bioprocess.”
While this means both BASF and its customers have an opportunity to learn how modulating raw materials at the start of the process has a direct impact on success, there’s also something to be said for speed. Upstream changes are quicker to implement than the formulation phase, which can take as long as 20 years.
BASF doesn’t take all the credit. It's only through a process of co-creation and constant dialogue with customers to discover their successes and pain points that the best results are achieved.
“One of the things we’ve been really diligent about is soliciting feedback from our customers,” Morale-Cummings says. “We’re trying to make it clear to them that we can be partners. You can come to us, tell us where you’re having issues, and we can go internally to make changes and improve your processes.”
She continues to say that it’s a partnership supported by the wealth of resources and experts at BASF versed in polymers and different chemistries. “By listening to customers, these experts can think about the chemistry and changes we can make to improve ingredients for an application which we can, in turn, test in the lab. We’ve been successful in making small changes to make an ingredient better. It all starts with listening to what the customer is having issues with.”
Butler adds that “we’re not doing this in a vacuum. We’re listening to the industry to make sure we’re doing the right thing.” Most of the innovation so far has been around the development of surfactants for shear protection.
Morales-Cummings shares Kolliphor P188 Bio as a specific example. “We’re developing new products that can serve processes that are more sensitive or demanding,” she says. “We expect to be sharing news soon.”
There’s an environmental benefit to customization too. “By having a raw material ingredient that’s exactly what your process needs, there’s less waste,” says Morales-Cummings.
“In the case of biopharma, a lot of sustainability’s attention is on the upstream piece because you’re using so much water. If you have a raw material that’s not great, and you can’t finish your fermentation, you’re tossing liters of water away. By having a critical ingredient that’s the right fit for your processes, there’s less likelihood of them being a failure.”
BASF’s manufacturing sites are highly integrated to increase energy efficiency, minimize waste, and maximize raw material utilization, all of which help put BASF on course to reduce its CO2 emissions by 25% by 2030 and achieve net zero by 2050.
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