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Volume 31, Issue 6
New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
Biopharmaceutical manufacturing continues to see growth as contract manufacturing organizations (CMOs) expand their services. The following is the latest news about CMO facilities, partnerships, and services.
Grand River Aseptic Manufacturing, Inc. (GRAM), a parenteral contract development and manufacturing organization (CDMO), announced on April 24, 2018 the purchase of a Bausch+Ströbel high-speed filling line with SKAN isolator, marking the second major equipment purchase of the year. In March 2018, the company announced the purchase of a new syringe filler and a land purchase agreement to acquire a 1.5-acre lot in Grand Rapids, MI.
The filling line can fill 200 vials per minute, which will more than triple the company’s manufacturing capacity, according to a press statement. The integrated fill line includes a vial washer, depyrogenation tunnel, and filling machine and the capacity to fill vials ranging from 2 mL–50 mL with 100% weight checks (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, as well as approximately 700 construction jobs. 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.
“Lonza Houston will serve as a center of excellence for cell-and-gene-therapy process development from concept through pre-clinical, clinical, and commercialization, all the way to the patient,” said Andreas Weiler, business unit head for emerging technologies at Lonza Pharma & Biotech, in a company press release. “This facility has the potential to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases under one roof.”
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 by the end of 2018.
“Lonza is committed to the evolution and cultivation of a diverse medical and life-science community in the Greater Houston area for many years to come,” said Marc Funk, Lonza Pharma & Biotech COO, in the press release. “The site is well positioned to meet the demands of the growing cell-and-gene-therapy field. Combining this leading-edge facility with our unmatched experience and expertise in cell and gene therapy will allow us to provide a key advantage to biopharmaceutical companies and academic researchers and ultimately to the patients they serve.”
AGC Biologics, a 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.
“These new state-of-the-art facilities will enable us to meaningfully advance and further integrate the development, manufacturing, and commercial functions within our dynamic global headquarters, as well as provide additional footprint for further manufacturing expansion,” said Gustavo Mahler, president and CEO of AGC Biologics, in a company press release.
The company also announced the addition of a 2000-L single-use bioreactor to its Berkeley, CA, facility to support its biologics capacity (5).
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 (6).
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 (7).
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.
“China is among the leading markets for CAR-T developers, and, together with the [US], represents the two countries with the highest number of ongoing CAR-T clinical trials,” said Dr. Chris Xu, CEO of Cesca, in a company press release. “This agreement with IncoCell signifies our first CDMO collaboration and is consistent with our goal of expanding beyond off-the-shelf cellular processing solutions into higher-value contract manufacturing and development services. Moving forward, we plan to pursue additional CDMO collaborations in selected markets while executing global distribution and other strategic partnering agreements for our highly differentiated X-Series line of products.”
1. GRAM, “Grand River Aseptic Manufacturing, Inc. Expands Pharmaceutical Manufacturing Capacity with Major Equipment Purchase,” Press Release, April 24, 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. Catalent, “Catalent Biologics and Valerius Biopharma to Collaborate on Manufacture of Specialty Biosimilars,” Press Release, May 14, 2018.
7. Cesca, “Cesca’s Device Subsidiary, ThermoGenesis, Expands into CAR-T Related Contract Development and Manufacturing (CDMO) Services,” Press Release, March 14, 2018.
Vol. 31, No. 6
When referring to this article, please cite it as the Editors of BioPharm International, "CMOs Expand Manufacturing Capacities," BioPharm International 31 (6) 2018.