WebJan 5, 2024 · 1. Introduction. In spite of the outstanding advances in the development of protein-based bio-therapeutics for treating severe diseases, such as various forms of cancer and immune-mediated disorders, parenteral formulations in commercial products are to date restricted to a small number of employed surface-active agents (also called … WebJun 15, 2016 · Formulation 4 contains protein-conjugated PEG and an atypically high concentration of sugar, both of which would lower water activity, resulting in osmotic nonideality. That further supports the association of water activity with deviations in osmolality measurements compared with theoretical calculations for some formulations. …
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WebApr 12, 2024 · Rentschler Biopharma, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, has appointed Thomas aus dem Siepen as Global Head Digital Manufacturing and Automation.As an experienced leader, he is a member of Rentschler Biopharma's Global Leadership Team and is responsible for the … WebBioPharm International Volume 30, Issue 1, pg 32–35 Grigorev Mikhail/shutterstock.com Lyophilization, or freeze drying, is a well-recognized method for obtaining stable ... formulation development from process development when creating a lyophilized solid, according to Sacha. “The excipients and active ingredient affect the thermal behavior ioannis lougaris medical center
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WebJan 13, 2015 · 25 Singh SK, et al. Best Practices for the Formulation and Manufacturing of Biotech Drug Products. BioPharm Int. 22(6) 2009: 32–48. 26 Voute N et al. Disposable Technology for Controlled Freeze–thaw of Biopharmaceuticals at Manufacturing Scale. BioProcess Int. 2(9) 2004: S40–S43. Further Reading Elvin JC, Couston RG, van der … WebThe study presented is a comprehensive overview of commercial parenteral protein formulations, approved by the European Medicines Agency (EMA), 1995-2024. The … WebAbstract. High-concentration protein formulations are in the focus of current pharmaceutical development because the required therapeutic doses of biologics, especially monoclonal antibodies, are extremely high, ranging between 5 and 750 mg per patient. Considering applications via the sub-cutaneous route, protein concentrations much above 300 ... ioannis kostoglakis weightlifting champion