GE's VP of BioProcess, Nigel Darby talks exclusively to the BPI European Summit

With BioProcessing International Europe less than a month away, we sat down with Nigel Darby, VP of BioProcess GE Healthcare Life Sciences, to discuss the current challenges facing the bioprocessing industry and how the biomanufacturing has changed over the past few years.

More mature industry 

“I think if you look at the biomanufacturing industry today, you see a transition to a much more cost‐focused maturing manufacturing industry, with more focus on cost‐of‐goods, facility economics and maximising profitability, in particular facility design and infrastructure create much discussion,” said Dr Darby, speaking ahead of his plenary presentations at BPI Europe, taking place in Prague on 2‐3 April 2014 (www.bpi‐eu.com). “In my plenary talk I will detail the factors to consider when choosing manufacturing technology, how to reduce cost of entry into biomanufacturing, and preview new biomanufacturing challenges, such as process development for more complex molecules entering the
clinic.” 

Flexible manufacturing

As therapies become more personalised and drug potency improves, the need for large, multitonneproduction facilities reduces. “For future drug portfolios you may never need to go beyonddisposable manufacturing. In the past companies constructed bespoke manufacturing
facilities toserve one product line, but now the focus is to be more flexible, to reuse and remodel existingfacilities, or even implement new processes into old infrastructure,” said Dr Darby, whose
companywill be hosting a special cocktail hour at the end of Day One.Enabling technologies such as in‐line dilution also play a role, particularly to adapt existinginfrastructure. “Companies are starting to use in‐line dilution and in‐line conditioning rather thanholding tanks for intermediate dilutions of pHs and salts. By doing so you remove the need forexcessive tankage and benefit from capacity savings and improvements in facility flexibility.” 

Improving access to emerging markets 

GE is also working hard to improve biomanufacturing accessibility for new entrants, particularly China. “We see a lot of new players coming into biomanufacturing, particularly in the emerging markets. China, for example, is reporting growth of 20%‐30%. The challenge for them is entry costs and having to work with a limited knowledge base. This is where GE can help, by acting as a technology integrator. “If you work with smaller players you need to take a more holistic approach, explaining
how you apply the technologies and maximise effectiveness? How do you right‐size infrastructure? What are the appropriate technologies in terms of delivering quality and yield at the right cost? The large established biomanufacturing companies understand this but the smaller players less so.” 

So what next for GE Life Sciences?

“We are excited and driven by the potential improvements in process development. The more you can control expression in USP the more you can simplify DSP ‐ controlling cell death, for example, provides opportunities to improve initial product quality. There is still so much to do” 

So why is it important that delegates come to BPI Europe?

“There is something for everyone. It’s a chance to listen to things that you don’t know about as much
as what you do know about – upstream practitioners listening to downstream and vice versa.” 

Dr Darby is presenting one Day One of BPI Europe at 09.10. Be sure no to miss his plenary talk on the day.

About GE Healthcare

GE Healthcare Life Sciences provides a broad range of products and services for biomolecule separations at all scales. Chief products include: • ÄKTAdesign™ chromatography systems and BioProcess™ media • Filtration systems and devices • Wave Bioreactor™ and mixers • Cell separation for isolating and purifying cells, viruses, and sub-cellular particles • Fast Trak™ BioPharma Services. Our products are used in the manufacture of the majority of all FDA-approved biopharmaceuticals on the market. GE Healthcare Life Sciences is a part of GE Healthcare, a General Electric company with more than 42,000 employees, providing transformational medical technologies that are shaping a new age of patient care

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