CMC Biologics discusses single-use

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Three CMC Biologics executives share their perspective of single-use technology and the significance of working with a reliable partner such as Thermo Fisher Scientific.

CMC Biologics is a contract development and manufacturing organization. We have facilities in the U.S. in Seattle and in Berkeley, California, and facilities in Denmark, in Copenhagen. We are the largest independent biological CMO so that means manufacturing of therapeutic proteins and we do that from cell line development all the way to commercial manufacturing. Our services span from cell line development with our proprietary system and other systems, process development, analytical development, formulation development, clinical manufacturing, obviously commercial manufacturing and we have facilities approved by FDA and EMA for service to our customers.

We have decided to invest in single-use technology very early on in 2009 and we see this technology as a significant advantage for us as a supplier but also for our customers. Single use technology enables us to minimize the capital investment required to update facilities. We also need to invest less time in operations that comprise the turnaround time for facilities, the evaluation time for the equipment, the cleaning time and cleaning modification time of the facilities and also enable us to operate as we are a multi-purpose facility, it enable us to operate multiple products and avoid cross-contamination.

Bob Munday, General Manager, Seattle Facility, CMC Biologics:
We're in the – we call it Line C Bioreactor Suite. It's where we have our Bioreactor 6Pack™ set up. We actually have a 500-liter N minus two bioreactor, a 2,000 liter N minus one bioreactor, and six N stage bioreactors, all 2,000-liter single-use bioreactors by Thermo Fisher.

The concept actually started on a napkin believe it or not. We were approached by a customer, and they needed to rapidly increase our capacity to meet their potential commercial needs. Last year we sat down with this customer and we came up with a plan, and it was all around single use bioreactors, and the use of multiple single use bioreactors for one bioreactor train. Then we went to Thermo Fisher, who has been a partner for quite awhile with us, and we sat down with that team and we mapped out using their single use technology in our facility to get 12,000 liters of capacity.

For us, the way we approach customers with the 6Pack™ bioreactor is actually a modular post. We can ramp up anywhere from 2,000 liters to 12,000 liters for a customer all based in this one room. If we have a customer who only needs a couple 2,000-liter batches, say two, we can process through and give them 4,000 liters. If we have a customer with greater needs, we can go all the way up to 12,000 liters of single use bioreactor capacity for that customer.

We work with the Thermo Fisher team to layout what we're going to need for production capabilities for the next year, two years, three years, whatever it is for a particular customer in this bioreactor facility, and they line up and make sure that the supplies for these bioreactors are here when they're needed at the time they're needed and the quality that they need it at because you don’t want to have leaks in your bioreactor bags, that’s a bad thing. And they’ve done a lot of work over the years to make sure that their single use bioreactor bags perform very well for us.

Peter Vilby, Cofounder and Senior Vice President, Supply Chain Management and Project Management, CMC Biologics:
Assurance of supply for CMC Biologics is absolutely essential. We have tight timelines for many of our customers and our position in the marketplace is depending on that we can deliver quality products on time. There’s so much at stake for us, and even more at stake for our customers. So reliability with regards to timing and quality is everything. It’s our reputation in the market and it’s the timelines for the customers.