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Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.
Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.
In the second half of the 2000s, Fujifilm was extending its business interests outside its traditional camera and digital products. The company already had a strong presence in medical diagnostics, and felt that many of the proprietary technologies cultivated in these businesses could be used in pharmaceuticals, according to Steve Bagshaw, managing director of Fujifilm Diosynth Biotechnologies, UK. Thus, in 2008, the company created a Pharmaceutical Products Division that includes a growing portfolio of companies, such as Toyama Chemical Company and Fujifilm Kyowa Kirin.
Fujifilm Diosynth Biotechnologies is another part of the Pharmaceutical Products Division. It was formed following the acquisition by Fujifilm of the Merck Biomanufacturing Network. Merck had created the Biomanufacturing Network following its acquisition of the former Avecia Biologics in February 2010, which it partnered with the former Diosynth Biotechnologies (previously owned by Schering Plough).
The company consists of sites in both the UK and the US, which according to Bagshaw, have complementary technologies and facilities and work closely together to share ideas, services, and expertise in order to benefit their customers. “While separate business units with individual leaders, the business is marketed as a single entity with a shared sales team, and the key R&D and quality functions are also unified under single leaders,” he notes. The decision on where a customer’s product is developed and manufactured depends on a number of variables, including geography, technical fit, and capacity.
Building a strong position
When Fujifilm acquired Fujifilm Diosynth Biotechnologies, the stated intent of the company was to become a leading global biologics CMO. “Our two former companies were recognized as world leaders in the development and manufacture of microbial-based biopharmaceuticals, but had somewhat limited capabilities and capacity in mammalian-derived products. To meet growing market demand, over the last two years we therefore upgraded our sites in both the US and UK,” Bagshaw explains.
Specifically, cGMP mammalian facilities at its Research Triangle Park, North Carolina site were expanded with the addition of a 1000-L single-use bioreactor (see Figure 1) that complemented the firm’s existing 2000-L stainless steel bioreactor and process-development capabilities at that site. At its Billingham, UK site, Fujifilm Diosynth expanded its mammalian capabilities with a new cell line and process/analytical development services and established a dedicated team of 30 people in this area. The latest high-throughput technologies are used to enable the rapid transition of biologics from discovery to clinic, according to Bagshaw.
In addition, a dedicated mammalian cell-culture manufacturing facility at the company’s Billingham site is currently under construction and due for completion in the fourth quarter of this year. This facility will primarily use single-use technologies, including a 1000-L single-use bioreactor; a second 2000-L bioreactor is also already planned for 2014. Furthermore, Fujifilm Diosynth’s Cell Banking Facility opened in May 2013 and is working on its first customer programs.
The company has not neglected its long-established microbial-based business either. Over the last two years, it has upgraded a number of development and pilot-scale laboratories at its Billingham site, with the installation of new equipment, including eight in-situ sterilizable 20 L Sartorius Stedim Biotech fermenters and a number of fully instrumentable DASGIP parallel bench-top high throughput units. The R&D teams at both the UK and US sites have also been significantly increased over the last 12 months.
Finally, both sites have seen upgrades in their analytical development laboratories, with the installation of new equipment (see Figure 2), including ultra performance liquid chromatography (UPLC), capillary electrophoresis-sodium dodecyl sulfate (CESDS), and imaged isoelectric focusing (IEF) instruments that deliver rapid results in support of the cGMP manufacture of customer drug products or as a stand-alone service, according to Bagshaw.
Taking advantage of single-use technologies
Much of the new capabilities that Fujifilm Diosynth Biotechnologies has installed incorporate single-use technologies. “Our decision to invest in single-use technologies and equipment at the two facilities was based on three factors: compliance, flexibility and speed,” Bagshaw observes. He points to the fact that single-use technologies are much more compatible in a multi-product facility because the risk of cross-contamination is much reduced, no matter how potent the product. Much reduced cleaning times also allow the company to offer a much faster turnaround between customer campaigns, and simplified materials and waste management are further benefits.
“In addition, a new facility using single-use technologies can be on the ground in a much shorter timeframe than a traditional stainless steel facility. The new facility at the Billingham site is taking less than 18 months from ground-breaking to validation, which can be compared to the 2-5 years that is required for a stainless steel facility,” says Bagshaw. The same is true for capacity expansion to meet customer demands.
Establishing key alliances
To reach its goal of becoming a leader in the biologics CMO industry, Fujifilm Diosynth Biotechnologies has extended its enhancement activities beyond its own facilities. Most notably, it recently formed a key alliance with Piramal Healthcare UK Ltd. “This partnership focuses specifically on the contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in biopharmaceuticals. It brings together the expertise of Fujifilm Diosynth’s biologics development and manufacturing with Piramal’s world-leading experience in ADC, offering customers a ‘one-stop-shop’ approach, thereby reducing complexities in the supply chain and vendor management relationships and leading to shorter time to clinic,” Bagshaw says.
Fujifilm Diosynth has already received substantial interest in this alliance and is in discussions with a number of customers for the development and manufacture of ADCs. The company is also exploring other opportunities. “We are always looking for ways to enhance our offering to meet customer needs, either by adding facilities ourselves, or working with third parties,” Bagshaw comments. In fact, the firm is currently in discussion with two companies regarding potential alliances, but he is not in a position to provide details at this time.