Q&A with Nicole Peuker, Principal Expert USP Development at Wacker Biotech: A Novel Approach for Refolding of Biopharmaceuticals

Image: Wacker Chemie AG

We spoke to Nicole Peuker, Principal Expert USP Development at Wacker Biotech GmbH, about microbial manufacturing, novel protein formats and the company’s latest refolding technology.

Q: How does the novel refolding technology differ from what is already available?

NP: “Poorly soluble substances often form aggregated inclusion bodies within the cell, which contain incorrectly and or incompletely folded target proteins. Recently Wacker Biotech introduced FOLDTEC®, its novel refolding technology for pharmaceutical proteins. With this new technology biopharmaceuticals that tend to aggregate can be efficiently produced in their soluble-active form in high yields.

The proprietary process utilizes specifically developed and optimized bacterial strains and a patented, antibiotic-free expression system. Furthermore, Wacker Biotech offers extensive expertise in the iterative screening of optimum refolding conditions in order to convert the insoluble target-protein aggregates into a biologically active form.”

Q: Could you tell us any more about how the refolding technology works? How does it reduce aggregation?

“FOLDTEC® is based on safe, highly efficient host strains and a strong scientific expertise in protein refolding. Not every customer molecule can be expressed in a soluble way. So if a refolding is essential, our tool box helps to identify most suitable refolding conditions very quickly. And we always have manufacturability as well as scalability in mind during the entire process development phase.”

Q: Are there other challenges with novel protein formats aside from aggregation?

NP: “The design of novel pharma proteins is getting more sophisticated. Fusing together functional domains with different physicochemical properties has advantages for drug development, but it’s a challenge for manufacturability! Wacker has worked a lot of difficult-to-produce molecule classes and will continue to adapt its technologies for all relevant new molecule classes.”

Q: What benefits do you see in microbial manufacturing? What sort of products does it work best with?

NP: “Our microbial expression systems are highly suitable for non-glycosylated pharma proteins. Wacker has worked a lot on antibody fragments – we can manufacture such fragments with superior yields and up to 3-times higher productivity compared to mammalian cells. Here microbial systems significantly reduce cost-of-goods by improving yields, lowering the costs of consumables (e.g. culture media) and shorter manufacturing cycles. Furthermore cell line development is faster compared to mammalian cells, which means our clients safe time to get their candidate to the clinics.”

Q: What can delegates expect for your presentation at BioProcess International Europe?

NP: “We will present a recent case study on recombinant expression and in vitro refolding of a difficult-to-manufacture protein for medical use. Finally we will provide insights in state-of-the-art microbial manufacturing of a commercial biopharmaceutical by refolding at Wacker Biotech.

Nicole Peuker is speaking at 3.05pm on Day 1 (Tuesday 12th April 2016) of the BioProcess International European Summit in Vienna.

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