By Cheng Liu, K. John Morrow Jr.
Addressing an important want by way of describing the technology and method concerned to advance biosimilars of monoclonal antibody (mAb) medicines, this ebook covers all elements of biosimilar improvement: preclinical, scientific, regulatory, manufacturing.
• Guides readers in the course of the complicated panorama concerned with constructing biosimilar types of monoclonal antibody (mAb) drugs
• Features circulate charts, tables, and figures that basically illustrate approaches and makes the publication understandable and accessible
• Includes a evaluation of FDA-approved mAb medicines as a short connection with proof and worthwhile information
• Examines new applied sciences and methods for bettering biosimilar mAbs
Read Online or Download Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development PDF
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Extra resources for Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development
D. from Columbia Law School. K. John Morrow, Jr. A molecular biologist, K. John Morrow, Jr. is president of Newport Biotechnology Consultants. He specializes in writing and consulting in the area of immunology, with a focus on antibody technology. D. from the University of Washington and did postdoctoral studies in Italy at the Università degli Studi di Pavia and at the Fox Chase Cancer Center in Philadelphia. He has been employed at several universities as a faculty member including Texas Tech and Kansas University and has also worked in the private sector.
As he explains, Preface although the power of the immune system to protect the body from disease has long been recognized, murine hybridoma fusion technology, developed in the early 1970s of the last century, has dominated drug development since its inception. Easy access to the production and engineering of murine monoclonal antibodies drove a revolution of drug discovery. The first two decades between 1975 and 1995 were marked by many challenges and the development of the field of molecular engineering.
While there is reason for concern, the weight of the evidence indicates that the mouse is an accurate model of the human immune system, with certain caveats. One of the most promising approaches to protecting the half‐life of engineered antibodies is the use of nanotechnological devices. In its most fundamental state, the design concept is a drug‐containing core in a soft sheath covered with polyethylene glycol, which attracts water molecules surrounding the nanoparticle with a liquid halo. Currently there are a number of nanotech li lii Preface applications that have received FDA approval, although none involving an antibody therapeutic.