Tech Review

More flexibility in upstream processing

16.11.2009

Only a year after bioprocessing world market leader Millipore Corp. entered into a partnership with Dutch stainless steel bioreactor specialist Applikon Biotechnology BV, the companies have rolled out a major project – the world’s first disposable stirred-tank bioreactor for process developers. Follow-on versions are slated to be launched next year, according to Dr. Andrew Bulpin, Vice President Up­stream Processing at Millipore. EuroBiotechNews spoke with Bulpin about the first-in-class system, the growing need for flexible production facilities and Millipore’s future strategy.

Dr. Andrew Bulpin is Vice President Upstream Processing at Millipore Corp., Billerica (US). After completing undergraduate studies, he undertook his PhD in Chemistry from the University of Caen (France). Bulpin then moved to the Australian National University at Canberra to pursue research on stereoselective synthesis. Later achieving his MBA from the University of Strathclyde (Glasgow, UK), he began his business career at a blood transfusion diagnostics company (Institut Jacques Boy, Reims, France) before joining Serologicals (Livingston, UK). Bulpin ultimately moved into a marketing position at the company’s US headquarters at Atlanta before Serologicals was acquired by Millipore in July of 2006. He then moved into his current business unit and position.


Euro|BioTech|News
Dr Bulpin, last year Millipore entered into a development and commercial alliance with Applikon Biotechnology B.V., a specialist for stainless steel bioreactors. Could you please describe the plan behind this partnership, and outline the market for­ces that drive it?

Bulpin:
Millipore has long been engaged in single-use disposable manufacturing products. One of the product ranges obviously missing was bioreactors in the upstream area. It was a strategic gap, and we were looking to close it. Millipore has expertise in plastics engineering, we were therefore looking for a partner company for bioreactors that could deal with the controllers and the software – and that was Applikon. The alliance was split into two halves. First off, it was a co-development arrangement; the second portion was a commercial arrangement. With the co-development, we worked together to develop a bioreactor aimed specifically at process development. The arrangement is limited to bioreactors scaled from 500 millilitres to 40 litres. We have effectively reached the end of that co-development arrangement now with the launch of the Mobius® CellReady 3L bio­reactor. The commercial agreement is very straightforward. Both parties can sell complete systems – by that I mean the controller, sensors, software, and the disposable bio­reactor as a start-up kit. The kit will include six of the disposable bioreactors. Thereafter, all repeat orders for the consumables will go exclusively to Millipore.

Euro|BioTech|News
The current product is a 3-litre bioreactor. When will Millipore expand the scale?

Bulpin:
We expect to launch two different sizes as part of a scaleable range in 2010. Furthermore, we have certainly been looking at a programme for developing a scalable bioreactor for use in pilot plants and small production scales.

Euro|BioTech|News
What are the differences in Millipore’s strategy and product development compared to its competitors’ portfolios?

Bulpin:
You have to look at the product we have brought to launch; the Mobius CellReady 3L bioreactor is a very simple form for a plastic single-use version of the glass and stainless steel bioreactor in use today in process development labs. Format, use and application are all very familiar. When you compare it with the competition, I think people are very familiar with the single-use bioreactor in the pillow-shaped format. While functional, the major challenge to this design is that the working volume for the system is only 50 percent of the total bag size, limiting its scalability. Alternative, scalable products are not currently available for process-development applications.

Euro|BioTech|News
Could you please outline the fields of application for the Mobius CellReady, and explain what distinguishes it from first-generation disposable reactors?

Bulpin:
This bioreactor is designed for the process development laboratory. It’s a bench-scale bioreactor, and as such it is the first-in-class. When you look at the other players out there who are developing single-use bioreactors, significant focus has been at pilot or at production scale. The Mobius CellReady bioreactor has a classical shape; it’s a rigid injection mould, and the material is a polycarbonate that is compatible with cell-culture processes. It is designed to perform exactly like the Applikon 3-litre glass fermenter with stirred-tank design. We designed it to fit to any controller out on the market. Basically, all you need is an adaptor for the motor. The Mobius CellReady comes pre-assembled and gamma-irradiated. In other words, you take it straight out the box, put it on the bench and inoculate it.

Euro|BioTech|News
Does it also feature disposable sensors?

Bulpin:
No. The current version does not have disposable sensing. We are relying on people to use their existing electrochemical sensors, which means that they have to be inserted under laminar flow. We talked to our customers about this extensively, and the indication we got back was that people prefer the reliability of the electrochemical sensors, and they didn’t see this as a major challenge.

Euro|BioTech|News
What are the specific advantages of a disposable system over stainless steel reactors for process development?

Bulpin:
The major advantage is that it is ready to use. When you look at how most process development labs run today, after having finished a cell-culture run, you have to autoclave the used bioreactor with the content to inactivate anything inside, then wash it, clean it, and reassemble it. Then you have to autoclave it again before you can inoculate. Depending on the way the laboratory is structured, this can take from one to four days. Once a run is finished with a disposable reactor, you can take the next one off the shelf and inoculate. That is much more efficient when you’re looking at operation and turnaround time in a laboratory. Often, the highly trained PhD scientists are the ones doing the cleaning of the bioreactors, because they want to make sure that if there’s a failure, it’s not due to dirty equipment. It’s very expensive, however, to have PhD bottlewashers. If you look at the savings you can make concerning turnaround time – we’re talking about 1-3 days with an average cell-culture run time of 12 days – you can save up to 25% of your time for extra science.

Euro|BioTech|News
Is there anything like this system under development at your competitors‘?

Bulpin:
I’m sure that people will copy the system.
Euro|BioTech|News
What are your market expectations for the new system?

Bulpin:
We’ve had very positive feedback from alpha and extensive beta testing. So we are very optimistic that the system, which is now out on the market, will do very well commercially. When we initially framed our marketing plans, we expected the uptake to be moderately slow, because we expected the Mobius CellReady to be introduced either with the purchases of completely new systems and/or to replace glass and stainless steel as some of the older glass bioreactors broke. But if what we have found through our own internal use at Millipore gives us an indication of what’s going to happen out on the market, we underestimated. We discovered that people would much rather take a Mobius CellReady straight out of the box and use it rather than be forced to do their own washing-up. Although we have a lot of glass and stainless steel bioreactors in our own laboratories, they aren’t being used. There’s already 100% use of the Mobius CellReady bioreactor.

Euro|BioTech|News
What can you say about the overall cost when you compare reuseable and single-use systems?

Bulpin:
You have to consider different factors when carrying out such a comparison. One is the total cost of acquisition. Another is turnaround time, which affects the amount of time available for extra research and so on. We do have a costing-model. The value proposition for a single-use bioreactor is very compelling.

Euro|BioTech|News
Into what fields of disposable technology is Millipore planning to expand in the future?

Bulpin:
We would expect to be a player in virtually all the fields for which we have individual devices. When you look more generally at the reduction in capital investments coupled with increased manufacturing flexibility, disposable technologies make huge sense. While the first biopharmaceutical processes yielded 0.5-1.0g product per litre, we are now in the 5g range. This ten-fold increase in yield means that what you historically needed a 15,000-litre bioreactor to produce, you can today produce in 1500 litres. This means that disposable bioreactors are a viable option right up to production scale. Moreover, if you consider the advances being made in molecular biology – breaking larger historical patient populations into smaller subpatient populations based on phenotype – then the absolute kilogramme requirement for any given antibody will progressively get smaller. The ultimate endstate of this scenario is personalised medicine, which translates into more and more drug diversity and a need for greater flexibility around manufacturing. We are going to produce multiple drugs in a single-production facility, which is ideally suited for flexible single-use production.

Euro|BioTech|News
In which areas does Millipore feel comfortable, and in which fields do you think you need to grow?

Bulpin:
We feel comfortable in all the areas we are active in today, both upstream and downstream. And we will continue to expand our capabilities while innovating to compress the production template.

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