BPTC Publishes New Book on Antibody Development
Despite the numerous successful monoclonal antibody products now on the market and in development, the development and commercialization of these exciting products remains challenging. To help companies maneuver their way through the difficult technical and regulatory challenges, BPTC is pleased to announce the publication of the second edition of its definitive book The Development of Therapeutic Monoclonal Antibodies Products. Completely revised and updated for 2017, this second edition of provides a roadmap for the development of monoclonal antibody products from initial discovery through the regulatory filing for first in human clinical trials. The primary focus of the book remains the technical, regulatory, and management issues related to process development, manufacturing, validation, and quality control of full-length single specificity monoclonal antibody products produced in mammalian cell culture. New to the Second Edition are an in-depth look at Quality by Design for monoclonal antibodies, an entirely new perspective on cell line development and engineering, and expanded chapters on upstream and downstream process development.
All around, The Development of Therapeutic Monoclonal Antibodies, Second Edition has been updated and revised to align with the current regulatory and industry practices and thinking that shape the present development and manufacturing environment for monoclonal antibodies. This book is a unique reference tool, developed and written by BPTC consultants with years of experience in guiding and assisting companies bring new monoclonal antibody products to the market. These consultants share their insights and wisdom within the pages of the book to make it a “must-have” reference for all involved in the monoclonal antibody field.