How KBI Helps Clients

KBI Biopharma is a biopharmaceutical Contract Development & Manufacturing Organization that accelerates the development of innovative discoveries into life-changing biological products and expands 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 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) for our clients.

KBI was founded in 1996 and operates 7 facilities: Durham and Research Triangle Park (NC), Boulder and Louisville (CO), San Diego (CA), The Woodlands (TX) and Leuven, Belgium.

Senior Management

Timothy M. Kelly, Ph.D.

President & CEO

Tim began his tenure at KBI in 2005, initially acting as Vice President of Biopharmaceutical Development where he led the establishment and growth of KBI’s analytical development, formulation development, and cGMP laboratory services business. He subsequently served as Executive Vice President of Operations with responsibility for KBI’s development and manufacturing functions in North Carolina and Colorado. Tim has overseen biopharmaceutical services for over 320 molecules at all stages of development and commercialization and has supported numerous successful FDA and international regulatory inspections throughout his career. Tim’s previous experience includes directing the quality control function for Diosynth Biotechnology, where he supported clinical and commercial biopharmaceutical products. Tim has over 20 years of experience in large molecule development and characterization. He earned his Ph.D. in Molecular Genetics & Biochemistry from Georgia State University.

Kathy S. Lee

Senior VP, Quality & Regulatory

Kathy is highly experienced in quality management and compliance for biopharmaceutical development and production. During her career, Kathy has hosted successful FDA pre-approval inspections and international regulatory inspections on behalf of multiple clients. Kathy previously directed both Quality Assurance and Quality Control functions for Diosynth Biotechnology and Quality Assurance at North American Vaccine. Kathy has been in biotechnology for more than 25 years and started her career in development roles with Life Technologies and Genetic Therapy (a Novartis subsidiary).

Carnley Norman, Ph.D.

VP, Manufacturing Operations, Durham, NC

Carnley has over 18 years of therapeutic protein and vaccine drug substance process development, characterization, technology transfer and manufacturing experience with KBI Biopharma, Novartis, Astra Zeneca (MedImmune), Amgen and Merck. At KBI, Carnley previously led the Downstream Process Development group for close to 2 years. Prior to joining KBI in 2014, Carnley led and managed the Manufacturing Science and Technology (MS&T) purification groups at Novartis Vaccines (Lab and Manufacturing Support groups) focusing on process validation, technology transfer, manufacturing support process optimization/improvement in support of flu cell culture manufacturing. During his career, Carnley also held technical leadership roles for 9 new product introductions to commercial manufacturing sites including 4 new drug substance facility start-up projects. Two of these projects won ISPE Facility of the Year Awards. He also led process modeling initiatives at Merck, Amgen, MedImmune and Novartis. This includes facility simulation, fit-to-plant related modeling and equipment modeling using computational fluid dynamics (CFD). Carnley received his Ph.D. in Chemical Engineering from North Carolina State University.

Sigma Mostafa

VP, Process Development

Sigma has nearly 20 years of experience in process development, process characterization and validation, and manufacturing of therapeutic proteins. At KBI, she is in charge of the cell line, upstream, downstream, and analytical development groups that support development of 40 – 50 molecules per year. These molecules encompass all phases of development and represent mAbs, bi-specifics & fusion proteins, enzymes, vaccines, and complex glycoproteins. Prior to joining KBI in 2010, she was with Eli Lilly & Co. and Diosynth Biotechnology. At Lilly she led a process development group and also the high throughput cell line selection group and was a CMC Core Team Leader. At Diosynth she was manager of the Cell Culture group and was responsible for developing in-house (Merck) and client processes. Sigma’s core expertise are in phase I through commercial process development, scale-up/scale-down, and tech transfer. Sigma earned her Ph.D. in Chemical Engineering from Northwestern University. She completed her B.S. in Chemical Engineering from the University of Texas at Austin with High Honors.

Wayne Yount, Ph.D.

VP, Biopharmaceutical Development, NC

Wayne joined KBI in 2005 as a member of the Biopharmaceutical Development team. Since that time he has focused on the establishment and growth of KBI’s analytical development, formulation development, and cGMP laboratory services business. Wayne has assisted in the development of over a hundred clinical and commercial protein therapeutics, including monoclonal antibodies, enzymes, PEGylated proteins, protein vaccines, and peptides. He has been associated with the successful formulation development of over 50 clinical and commercial biopharmaceutical products, including liquid and lyophilized dosage forms for intravenous and subcutaneous administration, at protein concentrations ranging from 1mg/mL to 200mg/mL. Additionally, Wayne oversees the microbiology and mass spectrometry functions at KBI in Durham and has also been involved in several successful Health Authority inspections including FDA and EMA. Prior to joining KBI, Wayne worked in proteomics for Serenex, a small biotech company and obtained his Ph.D. in Chemistry from Duke University.

Stewart McNaull, Ph.D.

Senior VP, Business Development

Stewart has nearly 20 years of experience in biopharmaceutical process development and manufacturing with a focus towards driving technology innovation to the manufacturing floor. He has led upstream process development and cGMP manufacturing groups, managing clinical and commercial program supply. Stewart has been a leader in the evaluation of single-use technologies and has played a key role in the design and implementation of five cGMP single-use manufacturing streams globally. He has designed several innovation initiatives, including development of new technical offerings for sales and marketing launch. Stewart maintains a strong industry presence by presenting at major conferences and as a steering committee member of the BPOG industry consortium for Technology Roadmapping. His previous experience includes technical roles at Bayer Biologics, followed by 15 years of biopharma CDMO technical and management experience. Stewart earned his Ph.D. in Chemical Engineering/Bioengineering at Georgia Institute of Technology.

Dan Povia

VP, Finance

Dan is a seasoned executive with over 30 years of work experience in financial and operational controls, financial reporting and forecasting risk management, audit and compliance. He has developed and executed multiple successful business plans for start-up venture backed companies and facilities. In a previous role as VP of Finance at Eisai Inc., Dan led the transition of the business functions of the multi-billion dollar acquisition to the parent company. He then initiated and implemented procurement practices resulting in significant annual run savings and systemic cultural changes. Dan earned his MBA at Duke University’s Fuqua School of Business having garnered the distinction of a Fuqua Scholar, graduating in the top 10% of his class. He obtained his BS in Economics with a dual major in accounting and decision sciences from the Wharton School, University of Pennsylvania. There he graduated with Cum Laude Honors.

Thomas Milici

VP, Engineering

Tom has over 20 years of experience in the design, construction and operation of large scale GMP production facilities. Prior to joining KBI, Tom held the position of VP Manufacturing Operations and Site Head for Emergent BioSolutions in Baltimore, MD. Tom’s experience includes the design, construction, commissioning, validation and operation of microbial and mammalian cell culture facilities ranging from 100L to 7,500 L total production capacity. Tom has taken two products through licensure including FDA, EMA and other regulatory agencies through the Mutual Recognition program.

Bob Todd

VP, Process Development, Boulder

Bob has over 25 years of experience in the development of processes for biotherapeutic products. Prior to joining KBI, Bob was a Director of Process Development at Amgen, responsible for developing advanced process modeling capabilities as well as implementing a global process technology platform for the production of monoclonal antibodies. With experience on over 20 different clinical and commercial development programs, Bob has gained experience with early and late stage process development activities for both fermentation and cell culture processes. Bob received his Ph.D. in Chemical Engineering from the California Institute of Technology and his B.S. in Chemical Engineering from the University of Michigan.

Dirk T. Lange

Senior VP, Operations, Boulder

Dirk has more than 16 years of experience in Biopharmaceutical Development, Manufacturing and Business Development. Prior to returning to KBI, he was Head of External Supply Operations at Novartis Biologics and held leadership positions in Operations, Project Management & Business Development at Sandoz Oncology Injectables, & Rentschler Biotechnologie. Dirk has extensive experience in technical operations, quality remediation, third-party operations & business development. He has also been involved in numerous successful Health Authority inspections including FDA, EMA and ANVISA.

Don Healey, Ph.D.

Senior VP, Operations, The Woodlands

Don has over 30 years experience in cellular immunology and immune regulation in both academic and biotech environments. Prior to joining KBI Biopharma, Don was Chief Scientific Officer at Opexa Therapeutics, developing autologous T-cell immunotherapies for the treatment of autoimmune disease. Previously, he held the position of Director of Immunology at Argos Therapeutics, and was responsible for the development of novel autologous dendritic cell therapies for the treatment of renal carcinoma and HIV. He is a former lecturer in immunology at the University of Leicester, UK, and held post-doctoral positions in the Department of Pathology, Cambridge University, UK, conducting studies on immunoregulation of autoimmune disease. Dr. Healey obtained his Ph.D. at the Hunterian Institute at the University of London, UK, and obtained his BSc in the Department of Pathology, Bristol University, UK.

Rachel Mandell

VP & General Counsel

Rachel has over 20 years of experience as a corporate attorney. In her previous role as Director, Legal at Lord Corporation, Rachel advised the business on commercial matters, provided primary support to the finance and M&A teams, and managed Lord’s subsidiaries around the world. She has extensive experience with cross border transactions, human resources and data privacy issues. Rachel has represented pharmaceutical companies on a wide range of issues as in house counsel and as outside counsel in connection with public offerings. She has negotiated private placements, clinical trial agreements, licensing arrangements and manufacturing agreements. Ms. Mandell worked at the start of her career with the firm that is now DLA Piper in its Baltimore office focusing on public offerings, private placements and mergers and acquisitions. Ms. Mandell has a BA from Duke University and a JD from the University of Maryland.

John F. Carpenter, Ph.D.

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.

Cori Gorman, Ph.D.

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.

Steven M. Cramer, Ph.D.

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.

Michael J. Betenbaugh, Ph.D.

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).