By Frank Roschangar, Highly Distinguished Research Fellow, IU Sustainability, Boehringer Ingelheim Pharmaceuticals, Inc.
Antibody-derived biological drugs are inherently unstable and over time they undergo physical changes e.g., unfolding, aggregation, and chemical modifications such as oxidation, deamidation, and fragmentation. The kinetics of the different degradation pathways are dependent on temperature and molecule mobility. Therefore, antibody-derived biological drugs are typically refrigerated at 2 – 8°C to maintain their quality and safety during storage and distribution. In addition, some molecules require further stabilization by drying, typically via lyophilization.
Cold chain and lyophilization are energy-consuming processes and produce significant amounts of greenhouse gases (GHG), and thus are important contributors to the environmental footprint of biopharmaceuticals. Via our Open Innovation portal opnMe, we are now inviting scientific experts to propose molecule non-specific approaches to stabilize antibody-derived biological drugs for long-term storage at room temperature. These approaches should also reduce the energy and carbon footprint of the manufacturing process compared to conventional lyophilization.
Avoiding a cold chain for antibody-derived biological drugs would not only have a positive environmental impact, it would also have beneficial societal and economic implications by improving global access to medicines, making logistics more robust and cost-efficient, and reducing medicine waste due to unwanted temperature excursions or inadequate storage. In addition, if there was no need to refrigerate the drug, patient convenience and compliance would likely increase, potentially leading to improved patient response to treatment.
Any proposed solution should be readily developable for parenteral administration and commercial-scale GMP manufacturing.
Would you like to contribute?
If you have an innovative idea on how to address this challenge and are interested in collaborating with our team of experts at the Pharmaceutical Development Biologicals Department in Germany, submit your proposal through Oct 15, 2023.
The selected project will receive an $80,000 grant for the implementation of an idea that can be completed within 12 months and has the potential for tangible impact. We look forward to your submission and working side-by-side with you!
Learn more and apply through our Open Innovation Portal, opnMe.com
About the Grant
The opnMe initiative originated from Boehringer Ingelheim’s Discovery Research with the aim to interact with researchers for the advancement of early preclinical projects in healthcare. opnMe has over 5,000 registered users and received 1,800 collaboration proposals since its inception in 2017. We have successfully interacted with scientists from over 70 countries, who either accessed our well-characterized molecules for preclinical research or collaborated with us on research projects with an impact for patients in need.
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com.
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