Download PDF eBook Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product,
Monoclonal antibodies (MAbs) are at the moment the main class of protein bio therapeutic being developed by biotechnology and pharmaceutical corporations. Monoclonal Antibodies discusses the challenges and points revolving round growth of a monoclonal antibody produced by recombinant DNA expertise right into a therapeutic agent.This book covers downstream processing which incorporates design of processes to fabricate the formulation, formulation design, fill and end into closure methods and routes of administration. The characterization of the ultimate drug product is roofed the place the use of biophysical strategies mixed with genetic engineering is used to grasp the answer properties of the formulation. The latter has turn out to be essential since many indications equivalent to arthritis and bronchial asthma require the growth of formulations for subcutaneous supply (SC). The event of formulations for IV supply can also be vital and comes with a special set of challenges. The challenges and methods that may overcome these limitations are mentioned in this book, beginning with an introduction to those points, adopted by chapters detailing methods to take care of them. Subsequent chapters discover the processing and storage of mAbs, growth of supply machine applied sciences and conclude with a chapter on the future of mAbs in therapeutic treatments.
- Discusses the challenges to develop MAbs for intravenous (IV) and subcutaneous supply (SC)
- Presents methods to satisfy the challenges in growth of MAbs for SC and IV administration
- Discusses the use of biophysical analytical instruments coupled with MAb engineering to grasp what governs MAb properties at excessive focus
Download PDF eBook Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product