Consideration of real-world handling in formulation development

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Ensuring that protein drugs are stable is a complex challenge. To be successful, formulation developers must think beyond the molecule and also consider how the finished product will be handled after it leaves the factory.

Protein-based drugs are sensitive environmental damage and should be handled with care, says Ahmad Sediq, PhD, senior group leader, formulation development and pharmaceutical services, at CDMO Lonza.

“Transporting protein drugs from one place to another can lead to mechanical stress (shaking, falling, etc.) or exposure to light and heat. These exposures are ‘stressful’ to the proteins and can lead to deterioration in product quality,” he explains.

Many manufacturers attempt to accommodate these constraints by preparing concentrated solutions that can later be diluted to therapeutically relevant concentrations, but this approach is far from simple, notes Sediq.

“The way the product is diluted, the diluent used, the final container in which the diluted product is collected are all factors that can negatively affect the stability of the protein and, in turn, lead to deterioration in the quality of the product. “, he continues. “The therapeutic efficacy of any drug can only be achieved if the quality of the product is not jeopardized. Instability of the protein may result in ineffective therapeutic effect and/or even adverse effects.

Real-world manipulation

To give formulators another approach, Lonza has partnered with companies in the pharmaceutical, biotechnology and nutrition sectors for RealHOPE, the Real-World Handling of Protein Drugs-Exploration, Evaluation and Education project.

This initiative, which is supported by the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations (EFPIA), will examine how handling practices can influence the production of formulations.

For Lonza, the initial focus will be to model real-world handling practices used after products are shipped. according to Sediq.

“The project will shed more light on end-user handling of protein-based drugs once a batch of drugs leaves the manufacturing site,” he points out. “This will be achieved by mapping handling procedures beyond the scope of the manufacturer, monitoring, through chips, the various environmental conditions a drug encounters during its life cycle after manufacture and batch release to use in humans.”

The plan then is to feed those findings back into formulation development and manufacturing to help customers produce products that are stable enough to move through the supply chain.

“Lonza, as a CDMO, must apply state-of-the-art simulation studies and analytical technologies to help our customers develop their products in the best possible way,” he explains.

Lonza and the other organizations involved in the project say the project’s findings will be presented at conferences and published in scientific journals.

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