Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, has announced that its Drug Product Services is participating in the Real-World Handling of Protein Drugs – Exploration, Evaluation and Education (RealHOPE) project. This initiative, originated by the Innovative Medicines Initiative and European Federation of Pharmaceutical Industries and Associations (EFPIA) partners, aims to measure real-life events during drug handling that can destabilize protein-based therapeutics.

Assessing protein stability in formulations is necessary for process optimization and ensuring the quality and safety of therapies. It is well known that vibrations, heat, or sunlight exposure affect the stability of proteins. However, little is known about the effects that handling during storage, distribution, and administration has on these products. 

The RealHOPE project was initiated to bring together experts from the industry, logistic enterprises, hospital pharmacies, and patient organizations to significantly improve the efficiency and effectiveness of the drug development process. The long-term aim is to ensure that the pharmaceutical sector produces more effective and safer innovative medicines for patients. The consortia have initiated the first project activities, namely the start of the surveys among hospital professionals and patients at home on their use and handling of protein drugs. 

Ahmad Sediq, senior group leader, Formulation Development, Drug Product Services, Lonza commented, “Over the past 20 years there have been numerous cases of severe adverse reactions or even deaths associated with improper and/or erroneous drug preparations in hospitals. Due to their sensitive nature, handling of protein-based solutions may jeopardize their quality by increasing levels of physical instabilities through aggregation or chemical degradation, such as oxidation. These impurities can lead to adverse drug reactions and/or alteration in the drug effectiveness. By becoming part of the RealHOPE Project, our goal is to thoroughly map out the real-life handling of these drugs in clinical practice or at a patient’s home, to develop simulation models and analytical methodologies to assess the impact of the handling on product quality and introduce best practices to control or avoid these stability and efficacy challenges.”

The project plans to utilize smart technologies to track light and heat exposure, shear stress and shock during real-life protein handling, as well as analyze related protein degradation. The data and process understanding obtained will be used to develop educational materials for clinicians, pharmacies, caregivers, and patients. The project also intends to open a dialogue with the regulatory bodies to create visibility for the challenges the pharmaceutical manufacturers are facing. The ultimate goal is to develop more robust processes, simulation models and analytical methods for ensuring safer protein-based therapies. 

Peter Droc, head Drug Product Services, Lonza, added, “Ensuring that protein-based therapeutics remain stable throughout the entire manufacturing, distribution, and administration cycle is critical in developing safe and efficacious therapies. Our participation in this consortium represents a key enabler to develop and optimize knowledge and tools addressing the stability issue and, ultimately, to offer increased levels of stability control to our customers.”