SC8B: Integrated Continuous Biomanufacturing – An Implementation Approach
TUESDAY AUGUST 14 6:00 – 8:30 PM
Robert Dream, Managing Director, HDR Company Ltd
The importance and value of continuous processing’s economic and sustainability advantages due to the modular nature of continuous processes means that the industry is able to adapt more rapidly to changing market demands. Factors other than scientific ones, are the barriers to change from batch to continuous production. The (bio)pharmaceutical industry has reached a stage that requires a change in the production paradigm. For 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.
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 has 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.
Agenda Items That Will Be Discussed:
- How to transition from batch to continuous
- Where to implement Continuous Manufacturing;
- Drug product compounding and formulation
- Which technology approach;
- Integrated contiguous biomanufacturing
- What best fits into your organization
- What are the new technologies in continuous processing
- Affinity ligands
- Prepacked columns (single use or multi use)
- Liquid Chromatography-Mass Spectrometer (LCMS)
- Control strategies
- Membrane technology
- How to develop a step-wise approach
- Plug and Produce
- Impact of big data
About the Instructor:
Robert Dream, PE, CPIP, Managing Director, HDR Company, LLC.
Robert Dream is an industry leader with 30+ years of experience, including 20 years of executive leadership in the pharmaceutical and biotechnology industries. He has led projects, improved processes, helped move drug substance and drug products from R&D, clinical, regulatory licensing approvals through operational excellence strategies and leading edge technologies. He is business minded person and has an innovative knowledge and knowhow of manufacturing, logistics, supply chain, risk mitigation and management. He is experienced in therapeutic biotechnology and biological drug substance and drug products manufacturing, with extensive hands-on, senior leadership and executive experience at world-leading organizations. He wrote numerous articles for many journals and publications and lead and presented at many institutions, organizations, and conferences. He is a registered professional engineer and an active member of the ISPE and PDA. He is a member of the editorial advisory Board; Pharmaceutical Processing, Pharmaceutical Manufacturing, Pharmaceutical Technology, Pharmaceutical Engineering, and the INTERPHEX Advisory Council. He is a member and Process Chair of the PDA “Aging Facilities Modernization” Team. He is the Chair of the ISPE GUIDE: “Biopharmaceutical Process Development and Manufacturing”; published 2013, ISPE “Sustainability Handbook”; Published 2015 and numerous other relevant publication to list few.