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J Pharm Sci. 2018 Feb;107(2):529-542. doi: 10.1016/j.xphs.2017.10.017. Epub 2017 Oct 23.

An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.

Author information

Biopharmaceutical Product Sciences, GlaxoSmithKline R&D, 709 Swedeland Road, King of Prussia, Pennsylvania 19406. Electronic address:
Drug Product Science and Technology, Bristol-Myers Squibb, One Squibb Drive, New Brunswick, New Jersey 08903.
Biopharmaceutical Product Sciences, GlaxoSmithKline R&D, 709 Swedeland Road, King of Prussia, Pennsylvania 19406.
Pharmaceutical Development & Supplies, PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Biologics Preformulation and Drug Product Development, Abbvie Bioresearch Center, Worcester, Massachusetts 01605.
Shire Pharmaceuticals, Industriestr 72, Vienna 1221, Austria.
Merck & Co., Inc., Biologics and Vaccines Development, 2000 Galloping Hill Road, Kenilworth, New Jersey 07033.
Formulation Development, Takeda Pharmaceuticals International Co., 40 Landsdowne Street, Cambridge, Massachusetts 02139.
Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Road, Tarrytown, New York 10591.
Protein Pharmaceutical Development. Biogen, 14 Cambridge Center, Cambridge, Massachusetts 02142.
Analytical & Pharmaceutical Sciences, ImmunoGen, Inc., 830 Winter Street, Waltham, Massachusetts 02145.
Shire, 300 Shire Way, Lexington, Massachusetts 02421.
Pharmaceutical Development, Alexion Pharmaceuticals Inc., 100 College Street, New Haven, Connecticut 06510.
BioPhorum Operations Group, Sharrow Vale Road, Sheffield, S11 8YZ, UK.


The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking 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 BPDG-Formulation Point Share discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices.


biopharmaceutical; design space; drug product; formulation; manufacturing process; quality by design; robustness

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