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Formulation: An intercompany perspective on biopharmaceutical drug product robustness studies

To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Workstream conducted an intercompany collaboration exercise, which included a benchmarking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The team discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices.

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Formulation: High concentration formulations survey

High concentration formulations can be challenging to develop and there was interest in the Formulations workstream in the comparative approaches taken towards stability testing, syringability testing, the approach to subvisible particles, how solubility, aggregation, and particle formation issues are studied, the challenges associated with high viscosity formulations in PFS, the use of needle-free delivery systems or large volume injectors, concentration-driven formulation challenges, approach to unstable biopharmaceuticals, how acceptable opalescence is defined, how Gibbs-Donnan and excluded volume effects for excipients are accounted for, among other more detailed questions

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