Titlebook: Challenges in Protein Product Development; Nicholas W. Warne,Hanns-Christian Mahler Book 2018 American Association of Pharmaceutical Scien

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The third stage and fetal adaptationng dosage form (liquid, dried), color (coloration of solution, color of cake), cake appearance (in case of a lyophilisate), opalescence, or turbidity, and—in some cases—even visible particles. “Maximum solubility” is a parameter that has been previously evaluated for proteins. But given the nature o

Corral

認(rèn)為

Aspects of monitoring in normal labourgh concentration protein formulations have an increased tendency for high solution viscosity, physical stability sensitivities (aggregation/particulation), and non-Newtonian solution behavior (shear thinning) due to high shear rates. Process unit operations can be negatively impacted by these factor

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J. P. Kraehenbuhl,C. Bron,B. Sordateraction between the drug product formulation and the primary packaging components may also impact adequate delivery of the product to the patient. Therefore, primary packaging development should be fully integrated into parenteral drug product development. This book chapter describes the basic func

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The Stemness of Perinatal Stem Cells,eutics in combination with particular usability needs. Introductory Sect.?. reflects on the growing requirements on drug delivery devices for biologics in connection with new indications and user groups. Section?. discusses the boundary conditions, physical basics and technical requirements. Section

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pessimism