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. From early-stage biotech to academic/non-profit organizations to many of the world’s largest pharmaceutical companies, KBI has served 250+ 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 4 facilities: Durham and Research Triangle Park (NC), Boulder (CO), and The Woodlands (TX).
Timothy M. Kelly, Ph.D.
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).
Abhinav Shukla, Ph.D.
Senior VP, Process Development & Manufacturing
Abhinav has over 18 years of experience in developing biopharmaceuticals from early development through commercial launch. Most recently he was Director, Manufacturing Sciences and Technology at Bristol-Myers Squibb where he successfully led the commercialization of Yervoy®, Nulojix® and Orencia®, in addition to other late-stage programs. He also led the creation of a platform approach for mAbs at Amgen. Abhinav is a known industry expert in biopharmaceutical development and has over 40 publications in this area. He serves on the editorial boards of several journals including Biotechnology and Applied Biochemistry and Bioprocess International. He has a Ph.D. in Chemical and Biochemical Engineering from Rensselaer and Bachelors and Masters degrees in Biochemical Engineering and Biotechnology from the Indian Institute of Technology, Delhi.
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.
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 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.
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.
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.
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