Titlebook: Lyophilization of Pharmaceuticals and Biologicals; New Technologies and Kevin R. Ward,Paul Matejtschuk Book 2019 Springer Science+Business

paradigm

T. Page McAndrew,Douglas Hostetler,Frances L. DeGrazio

材料等

Erwan Bourlès,Gael de Lannoy,Bernadette Scutellà,Fernanda Fonseca,Ioan Cristian Trelea,Stephanie Pas

Exposure

bromide

記憶法

Regulatory Aspects of Freeze-Drying,simple formulations, a number of post-approval manufacturing process changes occur occasionally due to their failure to consistently meet desirable target qualities such as reconstitution time, low moisture content, and stability. In most cases, the root causes for such failure are identified as poo

malapropism

Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT), and Statistical Aanding and process control, based on sound science and quality risk management (FDA, Guidance for industry, Q8(R2) pharmaceutical development. Dept. of Health and Human Services, Center for Drug Evaluation and Research. Rockville, MD, 2009; Mockus et al, Pharm Dev Technol 16: 549–76, 2011; Yu, Pharm

同步左右

Intuitive

Lyophilization of High-Concentration Protein Formulations,come? We consider this question, particularly for monoclonal antibody drugs, along with the rationale for developing HCPF and the issues encountered during formulation..Lyophilization is the technique of choice for stabilizing labile molecules. However, for the development of high-concentration, fre

WITH

兇兆

High-Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids,ies have shown that ssHDX metrics are highly correlated with stability on storage. ssPLL-MS provides complementary information on the protein’s side chain environment. The chapter summarizes the methods and recent results both ssHDX-MS and ssPLL-MS, and suggests directions for future research.