A bunched-up bundle of a protein-based biologic is practically useless. Unfortunately, protein aggregation creates a common problem in the bioprocessing of many therapeutics. Addressing this issue will probably depend on analyzing the problem in new ways, which could trigger changes in various parts of the process.

Recently, Wilson Meng, PhD, professor of pharmaceutics at Duquesne University’s School of Pharmacy, and graduate research assistant Ngoc Pham reviewed this problem and potential solutions.

When asked to pick out the most important finding from this study, Meng says, “There is a need to break from conventional formulation and development approaches. “Specifically, applying linear models trained using low-concentration formulations to high protein-concentration formulations would likely yield invalid results.”

Instead, scientists need more advanced approaches, Meng believes. “Researchers should invest in tailoring predictive modeling and analytical approaches to a given protein biotherapeutic,” he explains. “Each new protein entity deserves its own pre-formulation and formulation solutions.”

So, the processes might require more customization that matches the needs of a specific biotherapeutic to avoid aggregation.

Even more opportunities for advances lies ahead. For example, the method of preventing protein aggregation could vary in different bioprocessing systems. As Meng says, “Another area of opportunity is that there is a knowledge gap in controlling protein aggregation in cell-free synthetic manufacturing systems.”

As Meng and Pham described the goal of their study: “The purpose is to stimulate new dialogs that would bridge the interface between physical characterizations of protein aggregates in biotherapeutics and the functional attributes of the immune system.”

So, to keep biotherapeutics apart, scientists need to get together.

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