Expansions in Cell Culture Facility Offerings

Mirasol,Feliza;

Expansions in Cell Culture Facility Offerings

January 1, 2018

By Feliza Mirasol

Publication

Article

BioPharm InternationalBioPharm International-01-01-2018

Volume 31

Issue 1

Pages: 20–22

Recent investments show expansion activity in cell culture facilities.

Sergei Drozd/Shutterstock.com

The upstream cell culture sector has seen expansion activity recently as some contract biomanufacturers invest in their cell culture facilities. Major projects announced in the past year include Lonza’s new Ibex solutions that the company is building in Visp, Switzerland, to support multiple technologies, including monoclonal antibody (mAb) cell culture, and FUJIFILM Diosynth Biotechnologies’ new cell culture laboratories in Teesside, UK, among others.

Lonza investment in modular facility

Lonza is building Ibex, a complex of five modular buildings providing 100,000 m² of surface area. Construction began in June 2017. The first two buildings are due to be finished and ready for outfitting by mid-2018 and expected to be fully operational by 2020. In addition to Ibex, Lonza has previously built and licensed mammalian facilities in the United States, United Kingdeom, Spain, and Singapore (1).

Ibex solutions is a new biological development and manufacturing concept that couples flexibility in facility build-out with tailored business models leveraging the company’s expertise and service network in Visp, according to Marc Funk, COO, Lonza Pharma & Biotech.

“Ibex biomanufacturing comprises a modular, technology-independent development and manufacturing complex that is capable of supporting activities across multiple technologies, including mammalian, microbial, cellular, and bio-conjugate, from late drug discovery to manufacture,” Funk says.

The complex will be able to operate at capacities varying from single-use to large scale, depending on customer requirements, according to Funk.

In addition to infrastructure and know-how, Ibex offers flexible models to match and adapt to individual customers’ expectations and forecasts, according to Funk. The availability of a modular complex with pre-built shells means time-to-market can be reduced by 12 months or more, he asserts.

One of the two initially finished buildings at the new complex will be occupied by Sanofi, Funk says. This move is in line with a joint venture that Sanofi and Lonza entered into in February 2017. The two companies are jointly investing approximately CHF290 million (US$298 million), split equally between them, for the joint venture (2). The second of the two buildings will house a mix of customer-dedicated suites and have capacity for polysuites.

FUJIFILM cell culture laboratory expansion

In the third quarter of 2017, FUJIFILM Diosynth Biotechnologies, a biologics contract development and manufacturing organization (BioCDMO), opened 10,000 ft² of newly built cell-culture process development laboratories in Wilton Centre, Teesside, UK. The laboratories were built through a JPY 1-billion (US$8.9-million) investment, part of a greater JPY 14-billion (US$125-million) expansion announced by the BioCDMO’s parent company, FUJIFILM Corporation, in April 2017 (3).

The Wilton facility is located close to the company’s site in Billingham, UK, which allows for easy access to both facilities.

“There is great scientific talent in the Northeast of England which is a perfect synergy with the Process Development expertise that we have been developing over the past 25 years,” says a FUJIFILM official. “We are excited to be part of a growing industry and the part we play in growing our industry.”

Although the BioCDMO says it has intention to invest further in growing its process development capabilities, it has no concrete new investment plans at present.

The new laboratories are dedicated to supporting activities in the company’s Saturn mAb Platform, which is designed to enable rapid access to process development and manufacturing capacity.

“The foundation of FUJIFILM Diosynth’s Saturn mAb Platform was built on its 25+ years of analytical and process development and manufacturing experience. The platform has built-in best practices, from our Apollo expression system to the latest high throughput process development technologies for process development,” the official says.

“The platform is adaptable to customer’s existing cell lines as well. Once the platform has been proven to work for a customer’s monoclonal antibody, FDB [FUJIFILM Diosynth Biotechnologies] de-risks the production as we will guarantee performance,” the official adds.

“From a GMP [good manufacturing practice] perspective, the Saturn mAb Platform offers a dedicated high-capacity mAb-only manufacturing facility with a simplified off-the-shelf supply chain and batch documentation,” the official explains.

In addition to the Wilton facility, FUJIFILM Corporation’s overall JPY 14-billion (US$125-million) investment includes an expansion in the US at its site in Texas. The company completed a JPY 10-billion (US$89-million) cGMP production facility in April 2017 for its FUJIFILM Diosynth Biotechnologies Texas (FDBT) unit.

This facility was built in part with funding from the Biomedical Advanced Research and Development Authority, an office of the US Department of Health and Human Services. FUJIFILM plans to invest an additional JPY 3 billion (US$27 million) to outfit the Texas facility with mammalian cell-culture bioreactors (4).

The FDBT facility is scheduled to start operation in 2018 and will be the manufacturing center of excellence for the Saturn mAb Platform. It will have an initial cell-culture capacity of 6000 L via three 2000-L bioreactors. The facility is designed to allow for future expansion that can accommodate up to 24,000 L of upstream capacity to meet clinical and commercial demands.

FDBT was acquired by FUJIFILM in 2014 through its FUJIFILM Diosynth Biotechnologies USA subsidiary and became a wholly owned subsidiary in March 2017.

Other cell culture investments

In addition to Lonza and FUJIFILM, Sartorius Stedim Cellca, a part of Sartorius Stedim Biotech, also recently announced an investment in a new cell culture facility.

In September 2017, the company started construction on a new EUR 30-million (US$36-million) Cell Culture Technology Center in Eselberg, Germany, which is scheduled to be completed by the end of 2019. The location of the new facility places it in the northwestern scientific hub headquartered in Ulm, Germany (5).

The company has thus far been operating in a rented building in Laupheim, Germany. The new facility will approximately double the company’s space, and the new location will provide closer proximity to universities and research institutes in Ulm’s Science Park, according to the company.

The company purchased the property, which spans more than 6000 m², at Science Park III in Eselberg in November 2016. The Cell Culture Technology Center can be expanded by a further 5000 m² as needed, according to the company.

Sartorius Stedim Cellca, which develops cell lines and protein production processes, licenses technologies for the production of proteins, and offers cell culture media, currently employs around 90 people. The company intends to expand its workforce to more than 120 people over the medium term (5).

Further investment in cell culture capabilities includes pharma major Novartis. In August 2016, Jacobs Engineering Group, a provider of technical, professional, and construction services, was awarded a $100-million contract to expand Novartis’ biotechnology center in Huningue, France. The expansion project is scheduled to be completed by 2020 and adds cell-culture bioreactors to the site (6).

Jacobs is providing engineering, procurement, and construction management services and will increase the site’s production capacity by 70%.

In addition, it will create a second line of purification that allows for multiple drugs to be manufactured simultaneously. At 35,000 m², Novartis’ Huningue site houses one of the largest production facilities for mAbs produced from mammalian cells (6).

Another expansion move involves Sumitomo Dainippon Pharma, an Osaka, Japan-based pharmaceutical company, which boosted its cell-culture production capabilities.

In April 2017, the company formed a deal with Hitachi, a Japanese business solutions provider, to supply automated cell mass-culture equipment for regenerative medicine using human induced pluripotent stem (iPS) cells (7).

The equipment supplied supports Sumitomo’s research into making practical use of dopaminergic neural progenitor cells. The equipment consists of single-use consumables, such as bottles, tubes, and cell culture dishes.

The iPS cells can be cultured and differentiated efficiently because they can be manufactured in large amounts automatically and be observed under closed sterile environment, according to Hitachi (7).

In addition to supplying the equipment, Hitachi has formed a joint research deal with Sumitomo to evaluate the validity of processing methods that will be adjusted for practical use of the automated cell culture equipment.

The companies aim to use the equipment for the clinical treatment of patients with Parkinson’s disease with human iPS cells. iPS cells have the ability to be developed into different types of tissues and organs and can be potentially used as regenerative medicine to repair wounded cells.