The presenters provided:
- A high-level overview of continuous manufacturing including efforts and status for ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Guideline.
- Identify potential problems with excipients used in continuous manufacturing
- Discuss current and future continuous manufacturing equipment needs
- Explore future needs for excipients designed for purpose in continuous manufacturing; and
- Present a regulatory perspective on use of continuous manufacturing for pharmaceutical products.
Attendees were able to:
- Recognize similarities and differences between batch processing and continuous processing needs
- Ascertain basic material and process considerations for continuous manufacturing
- Anticipate future continuous manufacturing equipment and/or material needs
- Understand the current continuous manufacturing regulatory landscape
Joseph provides product and technology training for customers and IMCD staff, conducts on-site customer seminars, and advises with formulation development through excipient and process selection. Mr. Zeleznik also works to develop prototype formulations demonstrating the benefits of the many IMCD products and technologies. Prior to joining IMCD US, Mr. Zeleznik served as Manager, Technical and Regulatory Affairs at MEGGLE USA, Inc., where he was responsible for providing formulation and product application guidance as well as having quality and regulatory oversight for MEGGLE USA’s North American lactose manufacture. Before working for MEGGLE USA, Mr. Zeleznik was Associate Director, R&D with JRS PHARMA and Research Manager with Penwest Pharmaceuticals Co. Mr. Zeleznik has over 25 years’ experience in the pharmaceutical industry, having specialized in the development and application of high functionality excipients, and in particular, co-processing applications for the performance enhancement of excipients and pharmacologically active ingredients. Mr. Zeleznik received his B.S. and M.A. degrees in Chemistry from the State University of New York, College at New Paltz with a focus on instrumental analysis.
Mr. Zeleznik serves as a member of IPEC-Americas Executive Committee and has Chaired IPEC-Americas Quality by Design/Excipient Composition (QbD/EC) committee as well as assisted in the development of several IPEC Guides including the newly introduced Co-processed Excipients Guide.
Mr. Zeleznik has authored or co-authored multiple articles published across various industry journals. He was a contributing author to the Handbook of Pharmaceutical Excipients, 8th Ed. published in 2017 and participated in the development of the NF co-processed excipient monograph, Silicified Microcrystalline Cellulose.
Mr. Zeleznik is an avid outdoorsman, enjoying camping, hiking, biking, and wildlife photography and has been active as a cub scout and boy scout leader with Boy Scouts of America for many years.
Dave R. Schoneker
David R. Schoneker is currently an independent consultant, specializing in developing regulatory strategies related to excipients, food additives, color additives used in drug and dietary supplement development. With over 42 years of experience working in these areas, he has developed strong networks with regulatory agencies and pharmacopeias around the world.
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.
Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. His expertise has been invaluable in developing market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets. Mr. Schoneker also worked closely with Colorcon’s customers and suppliers to provide regulatory training and advice. From 1995 to 2018 he was Director of Global Regulatory Affairs. Prior to 1995 he was Director of Quality Assurance and Quality Control. He was employed at Colorcon from 1977 until 2019.
Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT).
Mr. Schoneker was the President of IACM in 2019 and has been on the IACM Board for many years. In these roles he coordinated IACM’s international regulatory activities related to Synthetic and Natural colorants for use in foods and drugs and participated as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA) for several years.
Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee. He is now serving as the Vice Chair for Science and Regulatory Policy, where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve Excipient Acceptability, Safety and Global Supply Chain Security. Mr. Schoneker also Co-Chairs IPEC’s QbD/Product Development Committee, Composition Committee and IID Working Group. He also is a member of the Board of Directors of the IPEC Foundation. He is the Global Expansion Coordinator for the IPEC Federation, and has been critically involved in the development of many of the IPEC groups and partnerships around the world.
He has acted as an interface with many international regulatory agencies and pharmacopeias for IPEC-Americas. He previously was the USP Liaison for IPEC-Americas and, for many years, represented them as a member of the United States Pharmacopeial Convention. Mr. Schoneker previously coordinated International Harmonization efforts for IPEC-Americas and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients.
He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification, and the appropriate use of certificates of analysis. He was involved in the development of several third-party auditing and certification programs and standards, such as EXCiPACT, NSF/ANSI IPEC 363 and the International Pharmaceutical Excipients Auditing, Inc. (IPEA). Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients and since 2010, has chaired the Coalition for Rational Implementation of the Elemental Impurity Requirements
Mr. Schoneker has participated in the area of Color Science for many years and is author of the chapter “Coloring Agents for Use in Pharmaceuticals” in the 4th edition of the Enclyclopedia of Pharmaceutical Technologywhich was published in 2013. He has also authored many other excipient regulatory, quality, supplier qualification and safety related papers in various journals and trade magazines.
Brian AC Carlin, Ph.D.
Brian Carlin is Director QbD/Regulatory at DFE Pharma. He previously worked at FMC, SmithKline Beecham & Richardson Vicks. He is a Fellow of the Royal Pharmaceutical Society, and holds honorary Professorships at DeMontfort University and University of Maryland.
He is the recipient of the 2014 IPEC One World Award for Regulatory Excellence, and the 2012 IPEC Foundation Award for Industry Research Achievement. He is the immediate past chair of the IPEC Americas QbD Committee.
He has a doctorate in Interfacial Rheology from London University, and a degree in Pharmacy from the University of Aston in Birmingham.
Dr. Kathryn Hewlett
Application Development & Innovation Scientist, DuPont Nutrition & Health
Katie is part of the industry leading Application Development & Innovation team at DuPont Nutrition & Health where she is responsible for educating and enabling customers on the performance enhancing benefits of performance excipients. Her areas of expertise include direct compression processes, modified release and Quality by Design. She received her Bachelor's Degree from Stanford University and PhD from Northwestern University, both in Materials Science.