Author: Hermann Mucke, PhD
By 2020, the current renaissance of biotechnology will have resulted in a broad range of products that will, almost without exception, involve a degree of protein engineering. This report discusses new developments in therapeutic protein engineering and developments that are likely to occur through 2020. Contents include:
State of the current technology and where the immediate development vectors are pointing
Current efforts to engineer developability into protein drug candidates
How major regulatory agencies might address engineered proteins
60 company profiles providing a cross-section of the corporate protein engineering environment in 2011
Directions the protein engineering business is likely to take in the context of technical, strategic, and financial terms
How globalization in the protein engineering and design field may imply sharper competition but also increased transnational cooperation
Engineering Next-Generation Therapeutic Proteins: Markets and Trends To 2020 discusses new developments in therapeutic protein engineering: The science and technology of modifying proteins (and the conditions of their manufacture) toward specific predefined properties that allow them to act as biological drugs. Although pharmaceutical protein engineering can target any type of protein, the focus of this report is on antibodies, and more specifically on modifications, derivatives, and analogs of monoclonal antibodies.
We introduce the nomenclature, review the state of current technology, evaluate progress made and problems encountered, and examine those areas where immediate development is likely. We focus on the many types of antibody fragments and on display technologies, which play a major role in antibody screening and maturation and have seen huge improvements during recent years. Also discussed are current efforts to avoid predictable properties that would made the new protein difficult to express, purify, or formulate or would compromise its stability.
Although there is a clear innovational and regulatory distinction between biosimilars and new biological drugs that result from protein engineering, this report provides a brief excursion into the biosimilars scenery. The way in which major regulators handle the issues of biological and pharmaceutical equivalence provides valuable clues to how they might address engineered proteins. While these would have to pass the same full regulatory review process as any new drug, many references will be made based on first-generation products that address the same target or have other similar properties of significance.
Engineering Next-Generation Therapeutic Proteins: Markets and Trends To 2020 profiles 53 companies that focus on the development of new drugs based on protein engineering, along with the status of their product candidates and alliances. An additional seven companies have been selected from the group that does not attempt to develop new therapeutic entities but provides developers with specific tools (methods, equipment, or software) to achieve their goals.
The final section of this report examines potential future trends in the protein engineering business. During the years to 2020, many protein engineering tools will continue to evolve, especially those which employ software for structure prediction and in silico immunology, while others will experience only refinements to what exists today. Major evolution will occur in protein characterization, with some new technologies but mostly through intelligent combinations of approaches which are already employed today and use different principles. Synthetic biology, designed to target biological effector sites that are not even known today, might then start the next round of innovation in pharmaceutical protein engineering.
About the AuthorHermann AM Mucke, PhD, spent 17 years in academia and industry before he founded H.M. Pharma Consultancy (www.hmpharmacon.com) in 2000 to become an independent pharmaceutical consultant, analyst, and science author. His last industry position was Vice President R&D in a European pharmaceutical company, which he helped take public on the Frankfurt Stock Exchange in 1999. Since then, Dr. Mucke, who holds a PhD in biochemistry from the University of Vienna (Austria), has become a consultant and advisory board member for several European and American pharmaceutical companies and a regular reviewer of drugs and patents for Thomson Current Drugs and Ashley Publications. Dr. Mucke is based in Vienna.