Formulation: An intercompany perspective on biopharmaceutical drug product robustness studies

Since its start in 2013, the Formulation Point Share has been busy. In February 2018 It published, An inter-company perspective on biopharmaceutical drug product robustness studies, in the Journal of Pharmaceutical Sciences which was viewed online over 1,000 times in the first few weeks.

Formulation and manufacture robustness studies are essential to developing robust pharmaceuticals that ensure the quality of the product administered to the patient. However, previously there was little guidance, literature or even agreement on the scope, design and execution of these studies.  This paper uses three case studies to illustrate that the ideal robustness study design for a biopharmaceutical drug product (DP) is a balance of experimental complexity, statistical power, scientific understanding and risk assessment. Recognizing the industry challenges in this area, the Formulation group provides recommendations for best practice and hopes that the work will facilitate further industry conversations on drug development encouraging industry alignment on DP robustness studies.

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