CMOs Expand Manufacturing Capacities

Biopharmaceutical manufacturing continues to see growth as contract manufacturing organizations (CMOs) expand their services. The following is the latest news about new CMO facilities, partnerships, and services.

New and expanded facilities

On May 15, 2018, Cambrex reported that it had completed a pilot plant expansion at its High Point, NC facility with the installation and commissioning of a fourth reactor suite. The new 400-sq.-ft. suite includes two 2000 L glass-lined reactors and a Hastelloy C22 filter dryer, allowing the manufacture of batch sizes ranging from 10–100kg under cGMP conditions for clinical-phase projects. The installation increased the site’s reactor capacity by approximately 30%, according to a company press release. The company noted that it also upgraded its analytical chromatography data systems for quality control and analytical R&D to Empower 3 software (Waters).

The company also reported on May 15 progress in construction for a $24-million facility at the company’s Charles City, IA plant, for the manufacture of highly potent APIs. A 4500-sq.-ft. production area, which will have a reactor capacity of 2200 gallons and will manufacture batches from 50–300kg, will operate to an occupational exposure limit down to 0.1µg/m (1).

On April 30, 2018, WuXi Biologics, part of WuXi AppTech, announced plans to invest $389 million (€325 million) in a new biomanufacturing facility in Mullagharlin, Dundalk, Ireland. According to the company, the new facility will use multiple single-use bioreactors for commercial biomanufacturing and is designed to be able to run continuous bioprocessing (2). A total of 48,000-L fed-batch and 6000-L perfusion bioreactor capacity will be installed. The site, on a 26-hectare (64-acre) campus, is the company’s first site outside of China. The investment is expected to create more than 400 jobs over a five-year span. The project is supported by the Irish Government through IDA Ireland, an economic development body for Ireland.

Lonza announced on April 10, 2018 that it has opened its dedicated cell- and gene-therapy manufacturing facility in Pearland, TX (3), a 300,000-sq.-ft. facility built in anticipation of rising demand from developers of cell and gene therapies. The facility offers integrated, “everything-under-one-roof” access to cell- and gene-therapy manufacturing technologies, the company reports. The Lonza Houston Center of Excellence is operational and is recruiting more than 200 full-time staff, including scientists, engineers, business personnel, and biotechnology professionals.

AGC Biologics, a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial manufacture of therapeutic proteins, announced in March 2018 plans for a new building complex that will house the company’s headquarters in Bothell, WA. The new 150,000-sq.-ft. complex will hold the company’s process development labs and corporate administrative offices and will provide expansion space for additional manufacturing capacity (4).

According to the company, the new facilities allow it to continue its expansion in the United States and will include a new R&D center dedicated to novel manufacturing technologies for faster development of therapeutic proteins.

The company also announced the addition of a 2000-L single-use bioreactor to its Berkeley, CA, facility to support its biologics capacity (5). AGC Biologics was formed recently with the integration of Asahi Glass Company (AGC) Bioscience, a glass and chemical producer under AGC; Biomeva, a CMO; and CMC Biologics, a contract biologics manufacturer (6).

Partnerships

Catalent Pharma Solutions and Valerius Biopharma, a Swiss biopharmaceutical company, announced on May 14, 2018 that Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase I through to commercial stages at its biologics manufacturing facility in Madison, WI for Valerius’ biosimilar products.

The project will use Catalent’s GPEx technology, which creates production cell lines in a variety of mammalian host cells. The company reported in a press release that, to date, more than 460 different monoclonal antibodies and monoclonal antibody fusions, and more than 50 different recombinant proteins, have been produced using the GPEx system, achieving fed-batch production titers of over 7 g/L.

Valerius Biopharma was founded to develop biosimilar products as alternatives to high-priced biologics, for indications where there is a substantial medical need. The company’s current product pipeline includes four biosimilar products in different development stages (7).

Cesca Therapeutics, a company specializing in automated cell processing and autologous cell-based therapies, has signed a license agreement through its subsidiary, ThermoGenesis, with IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, for chimeric antigen receptor (CAR)-T-related and other cellular processing contract development and manufacturing services (8).

Under the agreement, ThermoGenesis has granted IncoCell an exclusive license to purchase and use its X-Series cellular processing research devices, consumables, and kits for CDMO operations in certain Asia-Pacific countries. In exchange, ThermoGenesis is entitled to a percentage of IncoCell’s gross contract development revenues, including any potential upfront payments, future milestones, or royalty payments.

References

1.  Cambrex, “Cambrex Completes Pilot Plant Expansion at its High Point, NC Facility,” Press Release, May 15, 2018.
2.  WuXi Biologics, “WuXi Biologics to Invest Eur 325 Million to Build Largest Biomanufacturing Facility Using Single-Use Bioreactors in Ireland,” Press Release, April 30, 2018.
3. Lonza, “Lonza Opens World’s Largest Dedicated Cell- and Gene-Therapy Manufacturing Facility in Pearland, TX (USA),” Press Release.
4. AGC Biologics, “ACG Biologics Increases Footprint in Bothell, WA,” Press Release, March 29, 2018.
5. AGC Biologics, “AGC Biologics Expands Capacity at Berkely, California Facility,” Press Release, March 6, 2018.
6. AGC Biologics, “AGC Bioscience, Biomeva, and CMC Biologics to provide services under the brand AGC Biologics,” Press Release, Jan. 8, 2018.
7. Catalent, “Catalent Biologics and Valerius Biopharma to Collaborate on Manufacture of Specialty Biosimilars,” Press Release, May 14, 2018.
8. Cesca, “Cesca’s Device Subsidiary, ThermoGenesis, Expands into CAR-T Related Contract Development and Manufacturing (CDMO) Services,” Press Release, March 14, 2018.

Article Details

Pharmaceutical Technology
Vol. 42, No. 6
June 2018
Pages: 50–52

Citation

When referring to this article, please cite it as Editors of Pharmaceutical Technology, "CMOs Expand Manufacturing Capacities," Pharmaceutical Technology 42 (6) 2018.