BioProcess International Asia
Learn how global bioprocessing experts are driving down costs, improving timelines and navigating the regulatory landscape by attending BioProcess International Asia, held February 26-28, 2019 in Tokyo, Japan.
A Forward Look at the Future of Cell Therapy Manufacturing
Kim Raineri, Vice President of Operations, Nikon Cell Innovation
Full Presentation: Thursday, 28 February 2019 14:00–14:30
He told us that industry is in the early stages of cell therapies, similar to where monoclonal antibodies were in the early nineties. The questions that need solving revolve around how we successfully scale-up to prepare for commercial processes that can produce tens of thousands of units in a batch in an allogeneic process. And, if looking at autologous, industry must learn how to scale that out in a cost-effective and efficient way to make individual products not just for hundreds of patients but tens of thousands.
Rainieri also spoke on how his firm’s rich imaging legacy has left it in good stead to take on some of the challenges in cell and gene therapy manufacturing. “Vision technology, real time monitoring of cell culture are not area which are well developed and there are opportunities there to be seized upon,” he said.
Considerations and Strategies in Creation of GMP Master and Working Cell Banks to Meet FDA, EMA and NMPA Expectations
Liming Shi, Senior Director of QC, CMAB Biopharma Inc., China
Full Presentation: Thursday, 28 February 2019 14:00–14:30
As one of several experts talking about the challenges and key considerations of quality control methods for biopharmaceuticals, Shi spoke to us ahead of the conference about his talk.
The differing regulatory demands are creating a problem for the burgeoning Chinese biomanufacturing market, and domestic firms are attempting to balance guidelines from the EMA, US FDA and China’s own National Medical Products Administration (NMPA). And in light of recent scandals and mismanagement that have rocked the Chinese regulators, Shi suggests the NMPA is taking a conservative approach to bioproduction… for now.
Enabling Commercial Scale-Out of T-cell Manufacturing
Dr. Ohad Karnieli CEO & Co-founder, Atvio Biotech
Full Presentation: Wednesday, 27 February 2019 14:30–15:00
His talk forms part of the session entitled ‘Reducing the Cost of Manufacturing – Costs of Goods Calculations, Automation and Robotics.’ And in this podcast Karnieli gives a brief overview as to some of the issues in enabling commercial scale-out of T-cell manufacturing.
Interest in the sector is at an all-time high as industry, investors and services firm have been buoyed by the approvals of Kymriah and Yescarta. However, problems persist in bringing these ‘miracle’ therapies through to commercialization.
Karnieli talks about the role of closed systems in addressing the scalability issues, as well as the importance of understanding and controlling Key Quality Attributes.
Economic Analysis and Drivers for Continuous Processing Facilities
Yuki Abe Senior Consultant Engineer, Biopharm Services Ltd.
Full Presentation: Thursday, 28 February 2019 14:00 - 14:30
In this podcast, Abe gives an overview and insight into the economic analysis, drivers and strategies behind the implementation of continuous processing when planning and renovating biomanufacturing facilities.
While many firms and end-users have focused on the gap between the up and downstream, when it comes to implementing continuous biomanufacturing process, companies are struggling to balance the increased buffer and media necessitated by the perfusion method. This, therefore, undermines the concept that continuous bioprocessing is an effective way of reducing costs and facility space, something Abe says is driving companies to reassess how they source and use consumables.
