Formulation increasingly is recognized as a crucial component in drug-product success. In this month’s featured report, Rentschler authors report on the results of a recent survey and case studies that elucidate the current state of the art; Merck authors describe analytical approaches to coformulated products, and BPI’s senior technical editor shares discussions on drug-product development with past authors and BPI conference presenters.
Introduction: Drug Product Discussions
by Cheryl Scott, with Thomas Palm, Ed Maggio, and Craig Chambliss
Quality by design (QbD), risk management, and new technologies are shaping biologics formulation work in the 21st century. We saw much evidence of this at the BioProcess International Conference and Exhibition in Boston last fall, where a wide range of talks filled the Drug Product, Fill–Finish, and Formulations track during the week after Labor Day. Here the senior technical editor reports on those discussions and chats about specific topics with BPI authors from Bristol-Myers Squibb (high concentrations and viscosity) and from Aegis/Neurelis (excipients).
Analytical Strategies for Fixed-Dose Coformulated Protein Therapeutics
by George Svitel, Olivier Mozziconacci, Mark McCoy, Marco Blanco, and Jason Cheung
Coformulating multiple protein therapeutics into a fixed-dose, single drug product is an emerging strategy for biologics delivery. Mixing them into a combination therapy benefits patients, healthcare providers, and manufacturers. But coformulated products also bring complexities in formulation and analytical development, product characterization, and immunogenicity assessment. Here, authors from Merck describe analytical methods for evaluating multiple actives in a single product to answer questions about the mechanisms of degradation, aggregation pathways, and possibility of mixed aggregated formation in coformulated products. In a rapidly evolving field, formulators are working to defining analytical strategies, develop appropriate assays, and understand and manage potential product stability risks.
Early Stage Development of Advanced Formulations in the Drug Development Process Provides Competitive Advantages: Survey Predicts That Drug Product Formulation Recognition and Budgets Will Increase Significantly
by Birgit Schwab, Konstantin Petropoulos, Rebekka Ströver, Kristina Kemter, Michael Scholl, and Federico Pollano
Protein stability often is not given enough attention in early stages of development. Aggregation reduces drug activity, increasing the effective dosage size for some biopharmaceuticals or even inducing immunogencity in patients. Here, authors from Rentschler Biopharma and Leukocare report on a 2018 joint market study addressing this topic with 150 respondents. Results provide insight into the status quo and future of biological product formulation and its potential to help refine all steps in the value chain. The authors also bring a case study of highly concentrated subcutaneous formulations to drive value in product development.