Principles and Practices of Lyophilization in Product Development and Manufacturing (AAPS Advances in the Pharmaceutical Sciences Series , 59) (Original PDF from Publisher)

Principles and Practices of Lyophilization in Product Development and Manufacturing (AAPS Advances in the Pharmaceutical Sciences Series , 59) (Original PDF from Publisher)

The development of engineered antibodies such as Antibody Drug Conjugates (ADCs) , Bispecific T cell Engager (BITES) , Dual Variable Domain (DVD) and

Chimeric Antigen Receptor – Modified Tcells (CART) that are currently used as therapeutic agents for immunology and oncology disease conditions was made possible by the tremendous growth of the biotechnology/biopharmaceutical sector . All of these innovative pharmaceutical and biopharmaceutical formats , like existing medicines and biopharmaceuticals , have minimal stability in the liquid state and frequently need to be lyophilized to increase their stability and shelf life .

The chapters/topics in this book cover every aspect of the lyophilization process , product development and manufacturing , beginning with an overview , equipment needs , material characterization , formulation design and development , lyophilization process , various techniques for product characterization , scale-up/tech-transfer and validation . The use of CFD in conjunction with mathematical modelling is also discussed , as well as product development , scale-up and production . In addition a whole section on ” Preservation of Biologicals ” with nine chapters prepared by specialists and case studies is included in Principles and Practise of Lyophilization Process and Product Development .

Principles and Practices of Lyophilization in Product Development and Manufacturing (AAPS Advances in the Pharmaceutical Sciences Series , 59) (Original PDF from Publisher)

See also : An Introduction to Medicinal Chemistry, 7th Edition (EPUB)