Industry Experts to Provide Strategic Guidance as the Companies Advance Technologies Used in the Discovery, Analytics and Manufacturing of Difficult-to-Express Biologics
DURHAM, NC & GENEVA, SWITZERLAND, December 3, 2018 – KBI Biopharma, Inc. and Selexis SA announced today they have appointed four leading, internationally recognized scientists to their newly formed Joint Scientific Advisory Board (JSAB). The appointed members are experts in gene expression, cell line development, protein purification, analytics, and development of monoclonal antibodies and therapeutic proteins.
KBI and Selexis customers are addressing unmet medical needs by developing complex protein therapeutics. While this is promising for patients, these complex molecules are often more challenging to manufacture. As member companies of JSR Life Sciences, KBI and Selexis formed the Joint Scientific Advisory Board to foster innovation in established and emerging technology platforms used to bring these complex molecules to the clinic and ultimately to the market. The JSAB offers unparalleled scientific and business expertise with four notable appointments: John F. Carpenter, Ph.D., Cori Gorman, Ph.D., Steven M. Cramer, Ph.D., and Michael J. Betenbaugh, Ph.D.
“Gathering insights and know-how from this team of foremost experts in biopharmaceutical sciences will allow us to create new and added value for our client partners,” said Tim Kelly, Ph.D., president and chief executive officer of KBI Biopharma. “The formation of this JSAB represents a significant step along our path to realizing our vision as the CDMO of the 21st century and a force driving more high-quality biologics into the clinic more quickly.”
As part of JSR Life Sciences’ commitment to offer industry partners best-in-class contract development manufacturing (CDMO) services, KBI and Selexis have joined forces to provide industry partners “Gene to GMP™ in 9 Months,” the most robust and fastest service offering for the biopharmaceutical industry. The JSAB will play a strategic role in the enhancement of this new offering.
“We are honored to have the opportunity to collaborate with these leading scientific minds and commercial strategists,” said Igor Fisch, Ph.D., chief executive officer of Selexis SA. “The expertise that the new Joint Scientific Advisory Board brings to our respective companies will be invaluable in advancing novel and complex biologics into the clinic faster while working to ensure quality and safety to benefit patients in need.”
The inaugural JSAB members include:
Dr. Carpenter is Professor of Pharmaceutical Sciences at the University of Colorado School of Pharmacy, and a co-founder and co-director of the University of Colorado Center for Pharmaceutical Biotechnology. His research interests include mechanisms for protein degradation and stabilization in pharmaceutical formulations during bioprocessing and in delivery systems. Also, he has worked for several years to define rational strategies for stabilizing proteins and vaccines during freeze-drying and storage in the dried solid. He has published more than 280 peer-reviewed papers and is an inventor on more than 30 issued patents. He is editor for reviews and commentaries for Journal of Pharmaceutical Sciences. Dr. Carpenter serves on the editorial advisory boards for Pharmaceutical Research, The AAPS Journal, Journal of Pharmaceutical Sciences, Current Pharmaceutical Biotechnology, Molecular Pharmaceutics and BioPharm International. He has received several teaching awards and The Ebert Prize. He is a fellow of the American Association for Advancement of Science (AAS), the American Association of Pharmaceutical Scientists (AAPS) and the National Academy of Inventors. He has received the AAPS Research Achievement Award in Biotechnology. Dr. Carpenter also is the organizer of the Colorado Protein Stability Conferences.
Dr. Gorman has 30 years of experience in the biotechnology industry, including six years as CEO/chairman of BioXpress Therapeutics SA. She is currently Vice President of Precision Medicine and Manufacturing at Agenus, where she leads the effort in developing individualized cancer vaccines. She has helped early-stage biotechnology companies raise more than $80 million and has closed more than 35 partnerships. During her tenure at Genentech, Dr. Gorman helped develop several marketed products including Kogenate®, Activase®, Herceptin®, Xolair®, Raptiva®, Avastin® and Perjeta®. The total sales of these marketed therapeutics exceed $15 billion. She is an inventor on nine issued patents in the fields of gene expression and delivery and gene therapy Her scientific work has received over 21,000 citations. Dr. Gorman has received several fellowships from such organizations as the American Cancer Society, the National Cancer Institute, the European Molecular Biology Organization and NATO.
Dr. Cramer is the William Weightman Walker Professor at Rensselaer Polytechnic Institute and is known for his contributions to the separation of complex biological products and the development of chromatographic materials, processes and predictive tools for enabling their biomanufacturing. In addition, he has made seminal contributions to the molecular understanding of the interactions that create unique selectivities in these separation systems. His lab is currently conducting research on several areas related to protein-surface interactions including prediction of protein binding affinity and multiscale modeling of chromatographic systems, development of efficient antibody and bispecific antibody separation systems, fundamental studies in multimodal chromatography, multilevel automated peptide synthesis/screening system for design of affinity peptides, smart biopolymer affinity precipitation systems, biophysics of protein interactions with surfaces, ligands and proteins, platformable strategies for effective removal of process HCPs and integrated semi-continuous biomanufacturing processes. He was the editor of Separation Science and Technology for 20 years and has been awarded the Alan S. Michaels Award for the Recovery of Biological Products (ACS Division of Biochemical Technology) and the ACS National Award in Separation Science and Technology. He was also awarded Rensselaer’s Early Career Award as well as the School of Engineering Outstanding Professor and Research Excellence Awards. Dr. Cramer has been elected a fellow of the American Association for the Advancement of Science, American Institute of Chemical Engineers, the American Chemical Society and the American Institute for Medical and Biological Engineering.
Dr. Betenbaugh, an independent consultant as well as professor of chemical and biomolecular engineering and lead principal investigator of the Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) at Johns Hopkins University, is known for integrating systems biology with cellular, metabolic and biochemical engineering for eukaryotic biotechnology applications. Dr. Betenbaugh is one of the original pioneers of eukaryotic metabolic engineering and has made multiple landmark contributions in improving the efficiency and effectiveness of mammalian and insect production hosts, in fundamental discoveries in glycobiology, in applying systems biology to understand mammalian cells in biotechnology and biomedicine and in advancing knowledge about sustainable algal bioprocessing for biofuels and other products. Dr. Betenbaugh’s most significant achievements include the application of chaperones and foldases to increase protein folding and product yields from insect cells; glycoengineering in insect and mammalian hosts to produce sialylated high-value glycoproteins; anti-apoptosis engineering to increase mammalian survival and productivity; genomics, proteomics, glycomics, and systems biology models of mammalian hosts; microRNA analysis and genome engineering in mammalian cells; and advancing sustainable microalgae processing. Dr. Betenbaugh’s group was the first to undertake whole pathway metabolic engineering to overcome glycosylation bottlenecks in one of the first projects funded as part of National Science Foundation’s Metabolic Engineering Program, a forerunner to current synthetic biology efforts. His group was also one of the first to demonstrate apoptosis activation in industrial cell culture processes and is the world leader in controlling programmed death in cell culture processes. Dr. Betenbaugh received the D.I.C. Wang Award for Excellence in Biochemical Engineering (2017), the Marvin J. Johnson (2015) and James Van Lanen awards from the American Chemical Society’s Division of Biochemical Technology and the Cell Culture Engineering Award (2010). He served as a visiting scientist at the Kyoto Institute of Technology in 2001 and is an elected fellow of the American Institute for Medical and Biological Engineering (AIMBE).
About KBI Biopharma, Inc.
KBI Biopharma, Inc. is a biopharmaceutical Contract Development & Manufacturing Organization driven to accelerate the development of innovative discoveries into life-changing biological products and expand global access of medicines to patients in need.
From early-stage biotech to academic/non-profit organizations to many of the world’s largest pharmaceutical companies, KBI has served more than 300+ clients globally to accelerate and optimize their drug development programs.
KBI’s extensive track record of successful programs is a result of its unique approach: applying the insight gained from our advanced biophysical and analytical protein characterization techniques towards the development of robust and scalable processes. KBI delivers accelerated and integrated process development and cGMP manufacturing programs for a wide range of recombinant protein Active Pharmaceutical Ingredients (API) and cell therapies for our clients.
KBI was founded in 1996 and operates facilities in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), San Diego (CA), and Leuven, Belgium.
About Selexis SA
Selexis SA is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 100 drug products in clinical development and the manufacture of four commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. In June 2017, Selexis became part of the JSR Life Sciences group. JSR’s CDMO service offering leverages the full capabilities of Selexis’ proprietary SUREtechnology Platform™ to offer an end-to-end solution to industry. More information is available at www.selexis.com.
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