The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager (BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor that are currently being used as therapeutic agents for immunology and oncology disease conditions.  Year after year regulatory agencies have raised the bar, expecting to see more and more use of Quality by Design (QbD) elements during the development and manufacturing of a protein product i.e demonstration of in-depth understanding of product and process based on sound science. Device has become an integral part of the drug product and most of the biopharmaceuticals are being marketed as a combination product. A short survey of the market indicates that there is a strong need of a new book that will provide a “one stop shopping” for the latest information and knowledge of the advances made over last few years in the area of development and manufacturing of a biopharmaceutical combination product.  The new book entitled is a reference text book both for academia and biotechnology/biopharmaceutical companies.It reviews first the principles and provides new concepts/ perspectives, cover recent advancements and introduce new topics such as drug discovery, molecular assessment, preformulation and formulation strategies for new modalities such as, fusion proteins, and new techniques to analyze and characterize new modalities, process engineering and modeling for unit operations of manufacturing, compatibility and characterization of primary containers (Prefilled syringes and Vials) and device development & characterization.It emphasize strategies and approaches to the development of robust formulation, processes, analysis & characterization of drug product, drug delivery & devices that enable manufacturing of built-in quality biopharmaceutical product. The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.  weiterlesen