Enabling Decentralised Biopharmaceutical Manufacturing

A Regional Biopharmaceutical Supply Symposium

Efficient and agile production of high-quality biopharmaceuticals is a key priority for the pharmaceutical manufacturing industry. CPI and its industry partners will host this symposium to explore the challenges and opportunities of regional biopharmaceutical supply. Keynote speakers from industry will explain the demand for regional biopharmaceutical manufacturing and provide a case study of modular, integrated biomanufacturing technology in a regional context. 

From a technology perspective, there will be presentations on process automation, data acquisition from process lines, better real-time analytics, improved control strategies and vendor-agnostic platforms, which will all enable distributed manufacturing networks. 

Presentations

• The Demand for In-Country/​Regional Biopharmaceutical Manufacturing – PATH NGO - Simone Blayer (Global Head of CMC)
• Continuous Manufacturing Unit for Biosimilars in a Regional Setting — BiosanaPharma — Ard Tijsterman (CEO)
• Challenges and Opportunities of Regional Manufacturing — MSD — Marta Antunes (Dir CMC & Reg Aff)
• Process and automation strategies — CPI and Applied Materials
• Economic and production capacity analysis of vaccine application — Biopharm Services
• Biocomputer technology utilisation — BiologIC Technologies
• Critical quality attributes: technology review — SCIEX and CPI 
• Equipment and consumables supply options — Pall Corporation

After lunch, there will be: 

• A tour of CPI’s innovation centre with a focus on a demonstration of the technology created as part of an ongoing project, including a small-scale modular, integrated mAb production unit scaled for in-country manufacturing. 
• series of facilitated networking discussion groups covering small biomanufacturing demand and technology. 

The conference will conclude with a networking reception. 

Places are limited and offered on a first-come, first-served basis. Please register as soon as you are able. 

Post-event workshop

Please consider staying on in Co. Durham and contributing to an active discussion Gap Analysis Workshop: How to make clinical material with bench-scale continuous processes — March 29^th.

Pall Corporation will be leading a discussion-based workshop on the critical developments needed for small scale manufacturing systems to produce clinical and commercial therapeutics. Topics to include equipment & consumables design (bioburden, extractables, software), software/​control (data analytics validation, electronic batch records, QC sample/​data management), CQA QC (how best to automate, validation of inline tests), facility & supply chain (critical materials, SU issues, additive, reuse strategies, risk-based validation).

Please contact john_​welsh@​europe.​pall.​com to book your place.