Integrating the Pharmaceutical Manufacturing Process and Quality Organizations to Drive Right First Time Performance
The growth and complexity of modern manufacturing networks, together with the increasing focus by regulatory agencies on data integrity and product quality, are driving the need for data-driven collaboration across manufacturing process and quality organizations, including outsourced operations (CMO’s). A high level of data integrity is required so the business can trust its own operational metrics, and so that regulators and customers can trust the quality of the manufacturer’s products. Right first time performance requires easy access and automated contextualization of process and quality data from multiple disparate data sources, to understand process performance, minimize variability, and identify science-based process improvements. This presentation will describe how leading companies are achieving these objectives with a validated, high-integrity data-centric collaboration system that span organizations to identify, implement, document, and monitor process performance that minimizes risks and boosts the bottom line.
Justin O. Neway
Vice President, Process Production Operations
BIOVIA (Dassault Systèmes)
From Pilot to cGMP Commercial Production in 3 years – Incorporating the Latest Downstream Technology to Reduce Costs Whilst Increasing Yields Using Fluidized Bed Columns with Real-time PAT Control
Presented is the last 3 years’ scale-up work from laboratory and pilot scale chromatography to full commercial production of a MAb using a unique, successful, excellent downstream production scale technology with live PAT control that uses fluidised medium. This new slant is shown to increase yields, meet regulations and reduce costs at commercial scale.
- Two 250-litre, 600 mm ID, 800 mm height columns for full cGMP commercial production were commissioned and validated for injectables in July this year, 2016.
- MAb from 1,000’s litres of unclarified, un-homogenized, live biomass is fed directly into the column.
- This technology has been scaled-up from laboratory to two variable bed height 1.5 metre tubed, 56 litre columns.
- Eight ultrasound transceivers monitor and by feedback, maintain the fluidised bed to a fixed height, automatically, in real time.