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Booming Biologics Industry Calls for Additional Production Capacity

Fujifilm Diosynth Biotechnologies responds to the increasing demand by building UK’s first fully single-use biomanufacturing facility in only 14 months

VIDEO6_R11 11 Biopharmaceuticals are the world’s fastest-growing class of medicines; of the top ten therapeutics on the market today by revenue, seven are biopharmaceuticals and these therapies are about to make an even bigger impact in healthcare with more than 8,000 biologic drug candidates in research and development.

The challenge, however, is that biologics are protein-based drugs manufactured and isolated from natural sources – mostly from microorganisms like bacteria and mammalian cells, and need to be cultivated and purified in strict and highly controlled environments. This means that the development and manufacturing processes for these therapies are demanding and complicated. Many biopharmaceutical companies choose to outsource their biologics development and manufacturing to contract development and manufacturing organizations (CDMOs), which take the burden of manufacturing for biopharma companies.

This means as populations age, patient demand for global access to treatments for some of the toughest diseases –from diabetes to cancer to autoimmune diseases — are expected to accelerate.

It’s why , one of the world’s largest CDMOs, Fujifilm Diosynth Biotechnologies, decided to use its role in the booming biologics industry to address this challenge, by opening and building the UK’s first single-use facility in record time to increase their production capacita of biopharmaceuticals. The company decided to do this replicating their existing factory in the US.

“We decided to replicate our single-use facility in North Carolina, USA to Billingham, UK and it paid off. We were able to build the UK’s first single-use facility in only 14 months,” said Nick Martin, Head of Operations, Billingham, Fujifilm Diosynth Biotechnologies.

Nick Martin, Head of Operations, Billingham, FujiFilm Diosynth Biotechnologies

Nick Martin, Head of Operations, Billingham, Fujifilm Diosynth Biotechnologies

With hundreds of drugs in the last stages of clinical trials, Fujifilm Diosynth had experienced increasing demand from their global customers for additional production capacity in multiple markets and in meeting international regulatory requirements.

The company realized it would need additional manufacturing capacity that would allow them to quickly turnaround larger numbers of smaller batches. They felt the key was to create the right capacity for their customers –  and single-use technologies would allow them to flex and future-proof their production for batches of different biologics, and do so efficiently.

Bioprocess single-use technologies and the key to establishing biomanufacturing capacity

Even though CDMOs provide biopharma companies access to specialized, manufacturing services, expertise and cost control, they are faced with a common industry challenge of expanding manufacturing capacity in a world of a rapidly growing variety of biologics just waiting to be produced. And oftentimes, they choose single-use solutions to deliver that new capacity.

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Single-use solutions are disposable biomanufacturing consumables, which have become very popular in the bioprocess industry. With single-use, cleaning and steaming is minimized and sometimes eliminated, leading to reduced energy and water consumption, but most importantly, biopharmaceuticals are increasingly being developed and then produced for smaller patient populations locally or regionally, targeting the unmet medical needs. This has changed the manufacturing requirements.

Parrish Galliher, Chief Technology Officer, Upstream from GE Healthcare Life Sciences explains that many manufacturers are choosing single-use technologies over stainless steel technologies because “new drugs that are coming to the market are going to need additional capacity. The question is whether the capacity that we have is suitable for these drugs coming to the market. Single-use technologies are more suitable for smaller-scale and multi-product facilities.” In other words, single-use technologies can often be an excellent option for high-volume, diverse batch manufacturers like CDMOs.

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Not just the technology: The right supplier partner matters, too

As a key partner for Fujifilm Diosynth, GE Healthcare  was  able to help build the right capacity, and bring its expertise and understanding of the local regulatory environment to accelerate the development process in the UK.

The strong collaboration and strategic thinking around Fujifilm Diosynth’s new manufacturing capacity helped to deliver production capabilities for the CDMO in record time, allowing Fujifilm Diosynth to bring access to therapies to patients around the world.