The Biopharma Symposium: Process and Formulations by GEA-NUS PPRL & Roquette University

Transcription

1 The Biopharma Symposium: Process and Formulations by GEA-NUS PPRL & Roquette University Monday, 3 September 2018 Time Activity 08:00 08:30 Registration 08:30 09:00 Welcome address 09:00 09:50 Biopharmaceutical process technology transfer (Kean Chong Loh, Consultant, Roquette Asia Pacific) 09:50 10:40 Role of growth factors in biopharma cell culture media (Daniel Wils, Roquette) 10:40 11:00 Tea break 11:00 11:50 Common misconceptions in lyophilization and how to maximize your laboratory freeze dryer (Qing Qing Dai, Buchi Singapore) 11:50 12:40 Culture medium considerations for biopharmaceutical production using mammalian cells (Say Kong Ng, Bioprocessing Technology Institute) 12:40 14:00 Group photo and lunch 14:00 14:50 Molecular profiling and candidate selection of therapeutic biologics: from discovery to development (Peter M. Ihnat, Abbvie Bioresearch Centre) Fundamentals and applications of freeze drying, Sachin V Jangam, National University of Singapore) 15:40 16:00 Tea break 16:00 17:30 Panel Discussion End of Day 1 19:00 21:00 Networking dinner:@ The Scholar, NUSS Kent Ridge Guild House 1

2 Tuesday, 4 September 2018 Time Activity 08:30 09:00 Registration day 2 09:00 09:50 3D cell culture for drug discovery (Chi Zhang, Roquette Asia Pacific) Stabilization of therapeutic proteins (Sandeep B Kale, Institute of Chemical Technology, India) 10:40 11:00 Tea Physical stability profiling and chemical stability prediction for biologics (Likun Wang, HaiWei Technologies, China) 11:50 12:40 Advances in the characterization of protein therapeutics by QTOF LC/MS (Venks Gaddemane, Agilent Technologies, Singapore) 12:40 13:40 Lunch 13:40 14:30 Novel high throughput protein formulation screening techniques for stabilization (Yogesh Kumar Mishra, Roquette Asia Pacific) 14:30 15:20 Application of various vibrational spectroscopy methods in pharmaceutical/biopharmaceutical industries (Effendi Widjaja, MSD International GmbH, Singapore) 15:20 15:40 Tea 15: Panel Discussion End of Day 2 2

3 Wednesday, 5 September 2018 Time (Hr) Activity Pick-up from Kent Ridge Guild House Pick-up from Buona Vista MRT station Arrival at Agilent; to be served with Welcome drink Short presentations: Automated Sample Preparation on Agilent Assay Map Bravo & Advanced Bio column for Biopharma Application Lunch Catalyst to Transformation Global Solution Development Centre Lab Tour Features, Advantage & Benefits of Agilent Biopharma Solutions MS Workflow Demo: LC/MS workflow solutions for mab characterization (intact and peptide mapping) LC Workflow Demo: LC workflow solutions for mab characterization (aggregates and charge variants) Shuttle bus to Buona Vista MRT and NUS End of Symposium 3

4 Biography of Speakers Qing Qing Dai, BUCHI Labortechnik, Singapore Dai Qing Qing is the regional sales manager of BUCHI Labortechnik AG in the South East Asia and Pacific region. At the same time, Qing Qing manages the spray drying, encapsulation and freeze drying instrumentation lines in the same region and oversaw the regional launch of the BUCHI freeze drying range of products in Qing Qing graduated from National University of Singapore with a degree in Food Science and Technology and has worked in BUCHI for 4 years. Venks Gaddemane, Agilent Technologies, Singapore Venks worked at Biocon, a leading biopharma company in India for five years after completing his master s degree in chemistry. Then he moved to Singapore and joined Agilent technologies in the year 2006 as a LCMS Application Specialist to support for the LCMS business in the South East Asia. Since joining Agilent he has conducted many workshops, seminars and training courses focusing on liquid chromatography-mass spectrometry and its applications in Pharma, Biopharma, Food, Environmental and forensic and toxicology industries. Currently Venks working as a LCMS business Manager. Peter M. Ihnat, Abbvie Bioresearch Center Peter Ihnat leads the Biologics Preformulation and Drug Delivery Group at the Abbvie Bioresearch Center in Worcester, MA, USA. Peter s group is responsible for profiling and risk assessment of candidate biologics prior to preclinical formulation development. The diversity of evaluated biomolecules includes monoclonal antibodies, bispecific antibodies and antibody drug conjugates as well as other novel formats. Peter received his PhD in Pharmaceutical Sciences from the University of Nebraska Medical Center and undergraduate degrees in Biochemistry and Pharmacy from Rutgers University and Union University respectively. Sachin V Jangam, National University of Singapore Sachin Jangam is a Senior Lecturer in the Department of Chemical Engineering at National University of Singapore. Before joining the department as lecturer, he was research fellow in the Minerals, Metals and Materials Technology Centre (M3TC) at NUS. He completed his PhD in Chemical Engineering at the Institute of Chemical Technology, Mumbai, India. He has worked on experimental analysis and design of drying systems for various pharma and food products, this includes, heat pump drying, freeze drying, and spray drying. 4

5 Sandeep B Kale, Institute of Chemical Technology, Mumbai Sandeep Kale is Associate professor and Deputy Coordinator at Institute of Chemical Technology, Mumbai, India. He is member Board of Director of Abhay Nutrition Pvt. Ltd., India. He is a group leader of bioprocess technology and has over 10 years of experience in technology development, translation with 25 patents. He is recipient of Young Scientist Award in Biochromatography from SBCN, France; Dr. PD Sethi award and Dr. R.K. Khanna Memorial award. He is currently consultant to Mitsubishi Chemicals India Pvt. Ltd, Lactose India Ltd., Gharda Chemicals Ltd etc. He has commercialized 4 technologies and 2 are under pilot scale investigation. Kean Chong Loh, Consultant Loh Kean Chong is an independent GMP Consultant. He has more than 25 years of experience in business development, GMP manufacturing facility design, biopharmaceutical process development, Technology Transfer, biopharmaceutical manufacturing and validation for biotech and life Science industries. Past experience includes Singapore Biotech Pte Ltd, DSM Biologics, A-Bio Pharma Pte Ltd and Singapore bioprocessing and biomanufacturing centres (BTC & BMTC). His clients included GSK Biologicals Singapore, Goodwin Biotechnology USA, Samsung Biologics South Korea, National Biopharmaceutical Facility Thailand, PharmEng Technology Pte Ltd Singapore and etc. He was also appointed as an Executive Advisor of National University of Singapore Enterprise from 2012 to 2017 Currently, Dr. Loh is engaged as a consultant by a number of local and overseas Pharma and life science companies. Yogesh Kumar Mishra, Roquette Asia Pacific, Singapore Yogesh is a bio-pharmaceutical process development and manufacturing expert with over 10+ years experience. Providing strategic and technical guidance related to technical development, scale-up, process characterization, technology transfer, analytical method development and validation for wide range of biologics. Strong understanding of technical and regulatory requirements of Biopharmaceuticals and Vaccines. Experience in purification and high throughput excipient screening through his previous R&D roles with Biocon, Biological E, Dr. Reddys Lab, India and his PhD studies in ICT, India. Yogesh is currently leading Biopharma RND at Roquette, responsible for various projects in the field of cell culture application development, downstream application development and protein stabilization and formulation development. Say Kong Ng, Bioprocessing Technology Institute Say Kong Ng leads the Animal Cell Technology Group in Bioprocessing Technology Institute, A*STAR, Singapore, where he is responsible for mammalian cell culture media and bioreactor process research and development. He also has an extensive understanding of expression vector optimization and cell line development for the high-titer production of recombinant glycoproteins. He has experience working with both industry and academia from several biologics industry-funded research collaboration projects that he has coordinated and led, and from academic grantfunded projects. Dr Ng received his PhD from National University of Singapore in 2006 under the Singapore-MIT Alliance Programme. 5

6 Likun Wang, Nanjing Haiwei Technologies, China Likun Wang obtained his bachelor s degree from Zhejiang University and PhD from National University of Singapore. He joined Johnson & Johnson R&D in Belgium as Research Scientist in 2011 where he played key roles in designing and developing a number of successful drug products, apalutamide and ibrutivica among others. He then led the preformulation team in Johnson & Johnson R&D from 2014 as Senior Scientist and group leader. Dr Wang joined Jiangsu Hengrui Medicine Co. Ltd. as Site Director of Hengrui Nanjing Research Institute in 2015 where he successfully saw to the development of more than 10 NCEs and 5 super generics. Dr Wang has more than 30 peer-reviewed journal publications, several patent fillings and had made many invited presentations. In 2018, Dr Wang founded Nanjing Haiwei Technologies, a company focusing on drug stability prediction, NCE feasibility and developability assessments. Effendi Widjaja, MSD International GmbH, Singapore Effendi holds a PhD s degree in Chemical Engineering from NUS, Singapore and did his postdoctoral in Raman microscopy at the University of Michigan, Ann Arbor. He has two granted patents and over 80 published manuscripts. Currently he is working for MSD International in Analytical Chemistry Development & Supply division and responsible for the execution of analytical method development, validation, transfer, and troubleshooting in Asia Pacific regions, supporting both internal and external manufacturing networks. Before joining MSD, he worked at J&J, Abbvie, and ICES, A*STAR. His main areas of interest are vibrational spectroscopy, PAT and chemometrics, and analytical method development. Daniel Wils, Roquette Asia Pacific Daniel Wils graduated with a degree in biology, Daniel Wils joined the Roquette group in 1987 as the Biology and Toxicology Lab supervisor. He took the position of Head of the Biology and Nutrition Department in 1995, position hold till 2010 when he joined the Nutrition Direction as the Global Scientific Nutrition manager. Daniel was recently appointed Senior Expert in Nutrition and Health. He is responsible for a research portfolio devoted to healthy and active carbs. He is part of the Global Roquette R&D devoted to pharma, biopharma and cosmeto. He has been appointed an associate Professor of University at the Artois University in 2013 where he gives lessons in Nutrition and Toxicology and cooperates with the research teams. Chi Zhang, Roquette Asia Pacific, Singapore Chi Zhang has a broad range of research experience such as immunoassay and diagnostic assay development, cell culture and protein purification for monoclonal antibody, and microfluidic platform for cell culture through her previous R&D roles with Bosch Singapore, Credo Biomedical Singapore, Royal Institute of Technology Sweden and her PhD studies in NUS. Chi is currently a Pharma Senior Scientist at Roquette, responsible for various projects in the field of biomaterials and tissue engineering, cell culture application as well as protein stabilization and formulation related to Roquette s excipients development. 6