Titlebook: Lyophilized Biologics and Vaccines; Modality-Based Appro Dushyant Varshney,Manmohan Singh Book 2015 Springer Science+Business Media New Yor

fiscal

生命

VICT

Advance Understanding of Buffer Behavior during Lyophilizationto maintain biologic activity. The control of pH throughout the lyophilization process is critical to maintaining biologic activity and an acceptable shelf life. In this chapter, the critical aspects of selecting a buffer that achieves optimal stability throughout the freeze-drying process and on su

禮節(jié)

Advances in Instrumental Analysis Applied to the Development of Lyophilization Cyclesdevelopment is framed in the context of the recent International Conference on Harmonization Q8 R2 guidance and the quality-by-design (QbD) approach which focuses on the generation of a design space using well-known heat and mass transfer principles. The chapter briefly reviews analytical approaches

Magnitude

一大群

Lyophilized Biologics advantages and disadvantages of lyophilized formulations are important to consider when making product decisions. A clear understanding of why, when, and how to develop lyophilized formulations in a phase-appropriate fashion are essential, considering lyophilized formulations may be perceived as le

RUPT

Lyophilization of Therapeutic Proteins in Vials: Process Scale-Up and Advances in Quality by Designned through building a scalable freezing step in terms of ice nucleation along with the generation of a primary drying design space. Applying QbD to the design of the cycle allows for the consideration of scalability up front, removing the traditional “trial-and-error” approach, while understanding

inchoate

原來

Process Scale-Up and Optimization of Lyophilized Vaccine Productsof infectious diseases. Relative to therapeutic proteins (TPs) and small molecules, vaccine drug product development is more challenging and it is often stated that the “process is product” especially for live virus vaccines (LVVs). Given the global outreach of vaccines and the corresponding impact

CLAMP