Modernizing Biopharmaceutical Manufacturing: from Batch to Continuous Production

10:00 am Eastern Standard Time
3:00 pm Greenwich Mean Time
4:00 pm Central European Time
7:30 pm Indian Standard Time
10:00 pm Singapore Standard Time
 
Summary
The importance and value of continuous bioprocessing, both upstream and downstream has economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have already successfully adopted continuous processing. Factor other than scientific ones, are the barriers to change from batch to continuous production. an excellent example of the manufacturing strategies of the steel industry in the 20th century, when this industrial sector incrementally switched from batch to continuous operations. biopharmaceutical industry has reached a stage that requires a change in the production paradigm. For a certain class of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. a brief overview on the types of cell retention devices currently used in biopharmaceutical industry.
Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.
 
Presented by Robert Dream, PE, CPIP of HDR COMPANY LLC
Robert Dream is an industry leader with 30 years of experience, including 15 years of executive leadership experience, in the pharmaceutical, and biotechnology industries. He led projects, improved processes and operations through operational excellence strategies and leading edge technologies. He is business minded person and has an innovative knowledge and knowhow of manufacturing, supply chain and logistics, risk mitigation and risk management implementations. He is experienced in therapeutic biotechnology and biological drug substance and drug products manufacturing environments, with extensive hands-on, senior managerial and executive experience at world-leading organizations. He has made numerous publications and presentations. He is a registered professional engineer and an active member of the ISPE and the PDA. He is a member of the Pharmaceutical Processing Editorial Advisory Board, the Pharmaceutical Manufacturing Editorial Advisory Board, Pharmaceutical Technology Advisory Board, PDA Letter Advisory Board and the INTERPHEX Advisory Council.  He is a member and Process Chair of the PDA “Aging Facilities Modernization” Team. He is a graduate of Illinois Institute of Technology (BS and MS programs) and Drexel University (PhD program).
 
Sponsored by Pall Life Sciences

 
An Update on Significant Technology Advances Enabling Integrated Continuous BioProcessing
Continuous bioprocessing for biologics manufacturing is being adopted in the biopharmaceutical industry. Pall Life Sciences has brought several innovative technology platforms to the market to address the opportunities for Continuous Bioprocessing
In this webinar, Pall’s development journey in continuous bioprocessing will be introduced along with highlights of recent technology advances and product introductions for both PD and GMP operations.
Participants Will Learn:
– How to reduce facility footprint, capital expenses, and product cost of goods.
– How to improve your process productivity, flexibility, and further facilitate the utilization of single-use and/or disposable technologies.
 
Presented by Peter R. Levison, Senior Marketing Director, Downstream Processing, Pall Life Sciences
In his current position within Pall Life Sciences, Peter Levison is responsible to the biopharmaceutical business for the global product management of the continuous processing portfolio of products and process chromatography columns and systems. This embraces continuous processing technologies including those based upon acoustic wave separation, multi-column chromatography and Single Pass TFF. He joined Pall in July 2003 but has over 20 years experience in the biopharmaceutical industry, holding positions of increasing responsibility in research and development, technical management, and product management.
Dr. Levison holds a BSc (Hons) Class I in Biochemistry from the University of Manchester, Manchester, UK and a PhD gained in the Dept. of Biochemistry, University of Manchester. He has an MBA awarded through the Open University Business School, Milton Keynes, UK. He is a member of various professional bodies and has the status of C.Chem, FRSC (Chartered Chemist and Fellow of the Royal Society of Chemistry in the UK) and C.Biol, FRSB (Chartered Biologist and Fellow of the Royal Society of Biology in the UK)
 
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