In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades.
Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.
Spis treści
PART 1 – Introduction to Protein therapeutics: past and present
Early recombinant protein therapeutics
Evolution of antibody therapeutics
PART 2 – Antibodies: the ultimate scaffold for protein therapeutics
Human antibody Structure and Function
Antibodies from other species
PART 3 – Discovery and engineering of protein therapeutics
Human antibody discovery platforms
Non-antibody scaffolds and antibody mimetics
Protein engineering: methods and applications
Bispecifics
Antibody-drug conjugates
PART 4 – Physiological and manufacturing considerations for biologics
Pharmacokinetics
Safety Considerations for Biologics
Immunogenicity
Expression Systems for manufacture
Stability, formulation and delivery
PART 5 – Clinical applications
Protein therapeutics in autoimmune and inflammatory diseases
Protein therapeutics in oncology
Protein therapeutics in respiratory diseases
Protein therapeutics in infectious diseases and other indications
Rescue therapies
Biosimilars
PART 6 – Future horizons
Future horizons and new target class opportunities
O autorze
Tristan Vaughan is Vice President, Research and Development for antibody discovery and protein engineering at Med Immune. Based in Cambridge (UK), Dr. Vaughan leads the work of 110 scientists who are responsible for discovering and engineering around half of Med Immune’s biologics portfolio, and who have delivered over 50 protein-based therapeutic candidates into the clinical phases of development. Dr. Vaughan joined Med Immune, previously Cambridge Antibody Technology, in 1993 and developed the platform technology which built the first human antibody libraries of 10 E10 members. He is also a key inventor of Humira and Benlysta. Dr. Vaughan has over 60 publications in peer-reviewed journals to his name.
Jane Osbourn is Vice President, Research and Development at Med Immune and Site Leader for Med Immune Cambridge (UK). An expert in antibody engineering, Dr. Osbourn joined Med Immune, formerly Cambridge Antibody Technology, in 1993, and is an originator of key peer-reviewed publications and patents. She made a significant contribution to the discovery and development of marketed drugs (Humira and Benlysta) and more than 40 clinical candidates. Dr. Osbourn has worked across a range of disease areas and currently leads a team of researchers developing biosuperior biologics medicines in oncology, cardiovascular disease and diabetes. In addition, she is Chair of the UK Bio Industry Association, a Director of Babraham Bioscience Technologies and a Director of Cambridge Enterprise.
Bahija Jallal is Executive Vice President of Astra Zeneca and head of Med Immune, its global biologics research and development arm, based in Gaithersburg (USA). Prior to joining Med Immune, Dr. Jallal worked with Chiron Corporation where she served as vice president, drug assessment and development, and successfully established the company’s translational medicine group. In 2013, Dr. Jallal earned the Grace Award from the Cancer Research Institute. She has authored over 70 peer-reviewed publications and has over 15 patents.
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