Department of Rheumatology, The Parker Institute, Copenhagen University Hospital, Copenhagen, Denmark Department of Translational Immunology, Biopharmaceutical Research Unit, Måløv, Novo Nordisk, Denmark Department of Histology, Biopharmaceutical Research Unit, Måløv, Novo Nordisk, Denmark Department of Orthopaedics, Section of Hand Surgery, Gentofte University Hospital, Gentofte, Denmark Depar...

Mass spectrometry has already become an indispensable tool in the analytical armamentarium of the biopharmaceutical industry, although its current uses are limited to characterization of covalent structure of recombinant protein drugs. However, the scope of applications of mass spectrometry-based methods is beginning to expand to include characterization of the higher order structure and dynami...

BACKGROUND Knowledge in the era of Omics and Big Data has been increasingly conceptualized as a public good. Sharing of de-identified patient data has been advocated as a means to increase confidence and public trust in the results of clinical trials. On the other hand, research has shown that the current research and development model of the biopharmaceutical industry has reached its innovatio...

Subcutaneous (SC) injection is becoming a more common route for the administration of biopharmaceuticals. Currently, there is no reliable in vitro method that can be used to anticipate the in vivo performance of a biopharmaceutical formulation intended for SC injection. Nor is there an animal model that can predict in vivo outcomes such as bioavailability in humans. We address this unmet need b...

Tingting Shen, Jiucheng Shi, Na Wang, Xiufeng Yu, Chen Zhang, Jing Li, Liuping Wei, Cui Ma, Xijuan Zhao, Mingming Lian, Chun Jiang, and Daling Zhu Department of Biopharmaceutical Sciences, College of Pharmacy, Harbin Medical University (Daqing), Daqing, China; Biopharmaceutical Key Laboratory of Heilongjiang Province, Harbin Medical University, Harbin, China; and Biology Department, Georgia Sta...

The total sales of biopharmaceuticals have been steadily increasing for decades with growing approval of new drug products, especially for monoclonal antibodies. This trend motivates the development of deeper understanding and advancement of biopharmaceutical manufacturing operations. This article describes opportunities, needs, and challenges in process control and operations for biopharmaceut...

Due to different economic systems, historical traditions, market environment, legal concepts and other conditions, the patterns of biopharmaceutical enterprises corporate governance varies. This paper aims to prompt developed countries to draw on their strengths to encourage developing countries towards the introduction of governance and management practices in biopharmaceutical enterprises bet...

Biopharmaceutical manufacturing involves multiple process steps that can be challenging to model. Oftentimes, operating conditions are studied in bench-scale experiments and then fixed to specific values during full-scale operations. This procedure limits the opportunity to tune process variables to correct for the effects of disturbances. Generating process models has the potential to increase...