Wednesday, April 8, 2015

BDP Week 2015: Conventional vs Single-Use Facilities Panel Discussion

By: Maribel Rios, Managing Editor of BioProcess International

On Wednesday, 1 April 2015, the Biopharmaceutical Development and Production Week meeting held a Q&A session between attendees and a selected panel, moderated by Adam Goldstein (Genentech, a member of the Roche group). Panelists included Nuno Fontes (Boehringer Ingelheim), David Fritsch (Fritsh Consulting), Francis Kobina Insaidoo, PhD (Merck Research Laboratories), Chris Antoniou (Biogen Idec), and James D. Vogel (The BioProcess Institute). The panel first discussed the merits of moving to an all-single-use facility, such as Amgen’s facility in Singapore as opposed to continuing to use a stainless-steel-based facility and making modifications with single-use systems. Questions and discussion focused on the following:

·         Does building a complete single-use facility make sense? The panel agreed that there are some processes (e.g., early stage, smaller volume, pilot studies) in which the complete or near-complete use of single-use systems make sense. Larger-volumen(>2,000 L), commercial-scale, and dedicated processes would be more susceptible for stainless-steel systems.
·         How does cost of goods and other economic factors play a role? The panel agreed that manufacturers must examine all factors carefully, including timelines for building a facility. Other concepts, such as ballroom-style or modular facilities also can reduce timelines.
·         Are there single-use solutions for high cell density and high-titer processes? And are there ideas for addressing the limitations of single-use mixing of such processes? The panel responded that work on “loop” systems is ongoing through companies such as HyClone/Thermo/GE.

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