The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [electronic resource]

 0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: John Geigert

Ngôn ngữ: eng

ISBN-13: 978-3030137540

Ký hiệu phân loại: 615 Pharmacology and therapeutics

Thông tin xuất bản: Cham : Springer International Publishing : Imprint: Springer, 2019.

Mô tả vật lý: XXVIII, 426 p. 59 illus., 34 illus. in color. , online resource.

Bộ sưu tập: Metadata2

ID: 295388

This book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Tạo bộ sưu tập với mã QR

THƯ VIỆN - TRƯỜNG ĐẠI HỌC CÔNG NGHỆ TP.HCM

ĐT: (028) 71010608 | Email: tt.thuvien@hutech.edu.vn

Copyright @2020 THƯ VIỆN HUTECH