GE Healthcare’s European manufacturing and distribution site for cell culture products in Pasching, Austria, plays an important role in enabling GE to “accelerate development and manufacturing projects of biomanufacturing customers across the globe”. Mirroring the functionality at their US Center of Excellence for Manufacturing of cell culture products in Logan, Utah, GE is giving you the chance to get a behind-the-scenes look at the facility at the BioProcess International European Summit in April.
We spoke to David Radspinner, PhD, General Manager of GE Cell Culture, about the facility and the key factors in quality, reliable cell culture production.
Q: Why was Austria chosen for this facility?
DR: “The Austrian location of the site gives us a central EU location that further strengthens our supply chain for global biopharma companies, as well as serving as a logistics hub for distribution throughout Europe.”
Q: What are the best practices for securing long-term supply of cell culture media and process liquids?
DR: “Factors to consider are ensuring consistent quality standards, mitigating risks to the supply chain, and expanding capacity ahead of need. Underpinning all of these is effective quality control systems, which can help prevent issues from arising and detect them if they do.
A good practice to ensure security of supply is to have multiple manufacturing sites globally that are qualified and validated to the same quality standards. This ensures redundancy of capacity in case of an incident that stops manufacturing at one site.
In addition, a consistent global raw material sourcing program that includes the use of quality suppliers who are regularly audited, along with a multi-sourcing strategy for these raw materials, is vital for robust and resilient supply.”
Q: How are you trying to improve the quality of cell culture production?
DR: “All components used in the manufacture of biotherapeutics have to undergo stringent qualification and validation to ensure they can be incorporated into a manufacturer’s bioprocesses. To support that, as a media and process liquid supplier, GE has implemented global quality management systems to ensure supply consistency of high-quality material. This includes in-coming controls to detect and prevent raw material deviation in addition to monitoring for consistent quality of products prior to shipment.”
Q: What will the site visit at BPI Europe involve?
DR: “Visitors to the site will have the opportunity to see how a modern media and process liquids facility is designed, including:
- A small-volume production suite, equipped with tanks, filling lines, and a fully automatic packaging line.
- A large-volume production suite with filling lines, tanks and a system for process quality waters.
- Temperature and humidity controlled media suites, designed for continuous operation delivering product consistency
Visitors will also get the opportunity to listen to a talk from Andrew Falconbridge, Head of Downstream Processing at Alvotech, Iceland, who will discuss his insights on “Efficient downstream buffer management in a single-use bioprocess facility”, as well as get the chance to interact with senior GE Cell Culture leaders.”
The Pasching site visit is on Monday, 11th April 2016 as part of the BioProcess International European Summit. Find out more and register here.