The CDMO/CMO Report: Injectable Drugs

Demand for fill–finish capacity and sterile manufacturing is high, led by bio/pharma companies’ product portfolios and development pipelines in biologics and other key products, such as GLP-1 drugs. A roundup of the latest expansions by CDMOs/CMOs.

Demand for fill–finish capacity and sterile manufacturing is high, led by bio/pharma companies’ product portfolios and development pipelines in biologics and other key products, such as GLP-1 drugs. A roundup of the latest expansions by CDMOs/CMOs.

Ramping up capacity
Below is a roundup of some of the latest expansions by CDMOs/CMOs in sterile manufacturing and fill–finish capacity.

Novo Holdings’ pending $16.3-billion acquisition of Catalent. The largest move in the CDMO/CMO market for parenteral drug manufacturing is not an outright expansion but a pending mega acquisition that will move manufacturing capacity out of the CDMO/CMO market:  the pending $16.5-billion acquisition of the CDMO, Catalent, by Novo Holdings, the parent company of Novo Nordisk, which upon closing of the acquisition will net Novo three fill–finish sites and related assets in Anagni, Italy; Bloomington, Indiana; and Brussels, Belgium. The merger is expected to close toward the end of 2024, subject to customary closing conditions, including approval by Catalent stockholders and receipt of required regulatory approvals. After closing, Novo Holdings plans to sell the three fill–finish sites to Novo Nordisk for $11 billion. The Catalent acquisition is expected to gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.

Simtra BioPharma Solutions. Simtra BioPharma Solutions is investing $250 million-plus to expand its sterile fill-finish manufacturing campus in Bloomington, Indiana. Simtra BioPharma Solutions is the former CDMO, Baxer BioPharma Solutions, spun off from Baxter Healthcare and acquired for $4.25 billion by the private equity firm, Advent International, and growth investment firm, Warburg Pincus, last October (October 2023).

Simtra BioPharma Solutions is investing $250-plus million to expand its sterile fill–finish manufacturing campus in Bloomington, Indiana. A new, 150,000-square-foot building will be constructed to house two high-speed automated isolator syringe fill lines and a new high-speed isolator vial line equipped with three 30-squar- meter lyophilizers. Each process suite in the new building will be fitted with dedicated formulation/compounding rooms. The expansion will also include the addition of a dedicated clinical line that will utilize existing facility infrastructure.

The clinical line is expected to be ready to onboard new projects by the summer of 2025. It will provide the Bloomington campus with the ability to better accommodate projects that are in early phases of development (Phase I or II) and keep these projects onsite as they scale up for commercialization. Construction of the new building is planned to begin in June 2024 and is anticipated to take two years to complete, allowing for GMP readiness in late 2026. In aggregate, the expansion is expected to create hundreds of new jobs in Bloomington.

This latest expansion follows a $100-plus million investment in Simtra’s Halle/Westfalen, Germany, site in 2021 for the construction of a new building housing a high-speed syringe line and a vial line equipped with four lyophilizers. GMP readiness is anticipated by the end of 2024.

Lonza. Lonza is investing CHF 500 million ($547 million) in a large-scale, commercial drug-product fill–finish facility in Stein, Switzerland. The new facility follows the company’s previous investment in formulation and clinical drug-product manufacturing and will be completed in 2026. The facility will be able to fill–finish a range of products, including antibodies, other proteins and polysaccharides, mRNA products, and viral vectors. In addition, Lonza announced last October (October 2023) that it will construct a dedicated commercial-scale aseptic cGMP filling line at its Stein site. The new dedicated filling line will enable the aseptic filling of highly-potent antibody drug conjugates and lyophilization under containment.

Vetter. Vetter, a Ravensburg, Germany-headquartered CDMO of aseptic filling and packaging, is investing EUR 230 million ($252 million) in a new production building, which is currently under construction at its global corporate headquarters site in Ravensburg, Germany. The company first announced the investment in October (October 2023). The shell of the building is complete, following the start of construction in November 2021. The building is 122 meters long, 44 meters wide, and 32 meters tall and will feature several new commercial filling lines to increase aseptic manufacturing capacity. Vetter is planning to install the first cleanrooms by the end of 2024.

Also, last November (November 2023), the company received the permanent manufacturer’s authorization for its clinical development site in Rankweil, Austria.  The company had purchased the facility in 2020 and made subsequent upgrades to the facility. Vetter Development Services Austria acts as a European counterpart to the company’s clinical development and manufacturing site in Skokie, Illinois.

Thermo Fisher Scientific. Thermo Fisher Scientific is embarking sterile-manufacturing capacity at multiple sites. Its Ferentino, Italy, facility is undergoing an expansion of prefilled syringe capacity, including the addition of a new, high-speed filling line and doubling the current production area to 30,000 square feet. In Greenville, North Carolina, the company is adding three new prefilled syringe filling lines, including one small-volume line to support the development of new therapies and two large-volume commercial lines. In 2023, the company opened a new sterile drug facility in Singapore, to provide vaccine fill-finish capabilities along with end-to-end pharmaceutical development and manufacturing services.

BSP Pharmaceuticals. As part of an overall investment of EUR 530 million ($576 million) BSP Pharmaceuticals is expanding its site in Latina, Italy, designed for the manufacturing of cytotoxic and non-cytotoxic innovative products. The investments begin in 2024 and will be completed by the end of 2028. The new cycle of investment includes two additional conjugation suites of 6,500 g/batch monoclonal antibody (mAb) scale and two new sterile suites in full containment for sterile liquid and lyo vials with related clean utilities for manufacturing of cytotoxic compounds. Three additional sterile suites in full containment are to be built for manufacturing sterile liquid and lyo vials in the non-cytotoxic site for biologics and small-molecule innovative molecules for immuno-oncology and immunotherapy.

Grand River Aseptic Manufacturing. Grand River Aseptic Manufacturing (GRAM) announced this month (May 2024) that it will build a new syringe and cartridge filling center at the company’s site in Grand Rapids, Michigan. The center is 150,000 square feet and is designed to hold up to four syringe/cartridge filling and inspection lines. The new center is adjacent to GRAM’s existing 200,000-square-foot finishing and warehouse center. It brings the CDMO to five manufacturing facilities and more than 450,000 square feet of production space. GRAM estimates building construction will be complete in 2025, with new filling and inspection equipment installed in 2026.

PCI Pharma Services. PCI Pharma Services announced earlier this year (2024) that it has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, New Hampshire, campus. Twin lyophilizers and a large-scale isolator filling line are being installed at the forthcoming 50,000-square-foot plant, as foundational components of a previously announced and multi-year $100 million capital investment project. The facility will provide increased capacity, including an aseptic fill-finish line within a fully isolated containment system, complete with twin 430-square-foot lyophilizers featuring automatic loading and unloading systems. The integrated filler will be capable of manufacturing batch sizes of up to 300,000 vials at a rate of up to 400 vials per minute, providing large-scale capacity for the filling of late-phase clinical and commercial small molecules and biologics, including drug products with monoclonal antibodies, oligonucleotides, fusion proteins, and peptides. Engineering and validation runs at the new facility are scheduled to occur in late fall 2024, with the line ready for GMP production in the first quarter of 2025.

Jubilant HollisterStier. Earlier this year (2024), Jubilant HollisterStier opened a third sterile fill–finish manufacturing line and broke ground on the next phase of its facility expansion at its site in Spokane, Washington. The expansion includes a new high-speed commercial fill–finish line, which is part of a 50,000-square-foot facility expansion, which increases the company’s production capacity by 55 million units per year. It also includes an additional three compounding suites with capacity for up to 2,000-L bulks and disposable, single-use compounding and filling technologies. The line is also outfitted with two new 300-square-foot lyophilizers.

Alcami. In February (February 2024), Alcami announced the expansion of its sterile fill–finish manufacturing capacity with the addition of a new sterile fill–finish line with isolator and two lyophilizers at its existing site in Charleston, South Carolina. The new sterile filling line provides the flexibility to fill liquid and freeze-dried vials under isolator technology at clinical and commercial scale.Curia. Curia is expanding prefilled syringe (PFS) manufacturing capacity at its site in Albuquerque, New Mexico. In addition, the company invested in a Bausch & Ströbel Variosys flexline with a SKAN isolator bringing on additional capacity for both vial and/or PFS/cartridge manufacturing. The new manufacturing line will be qualified in the fourth quarter 2024. 

Curia. Curia is expanding prefilled syringe (PFS) manufacturing capacity at its site in Albuquerque, New Mexico. In addition, the company invested in a Bausch & Ströbel Variosys flexline with a SKAN isolator bringing on additional capacity for both vial and/or PFS/cartridge manufacturing. The new manufacturing line will be qualified in the fourth quarter 2024. 

WuXi STA. WuXi STA announced last year (2023) that it had launched a high-potency (HP) sterile injectable manufacturing line at the company’s drug-product site in Wuxi City, China. The Wuxi City drug product site currently has sterile injectable manufacturing lines that support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges. In its 2023 announcement, the company said by 2024, it plans to add two more injectable manufacturing lines at the same site, with additional lines also set to be added to its site in Couvet, Neuchâtel, Switzerland, and upcoming site in Middletown, Delaware. 

Carbogen Amcis. In 2023, Carbogen Amcis opened a new 9,500-square meter sterile injectable drug-product manufacturing facility in Saint-Beauzire, France. The new facility increased the company’s product development and manufacturing capacity for liquid and freeze-dried products for preclinical and clinical trials as well as small-scale commercial use.

Resilience. National Resilience, a CDMO of biologics and advanced therapies, announced in February (February 2024), the expansion of the company’s clinical and commercial drug-product manufacturing capabilities across its network. In Cincinnati, Ohio, at least $225 million is planned to be invested to increase the site’s drug-product capacity. The site has three high-speed fill lines for vials, cartridges, and pre-filled syringes (PFS), with a fourth PFS fill line slated to be ready by 2025. The facility is also expanding to six device assembly and packaging suites by 2025. Additionally, the company is expanding its drug-product capabilities at the company’s  facility in Research Triangle Park, North Carolina, by using a modular design within its segregated expansion space to offer drug-product manufacturing for multiple modalities. The site has drug-substance and drug-product capabilities in support of gene-therapy medicines. It also has 45,000 square feet of grey space available for additional expansion for drug-product operations. 

INCOG BioPharma Services. INCOG BioPharma Services is adding a high-speed filling line that will provide an additional 100 million units of syringe- and cartridge-filling capacity at its site in Fisher, Indiana. This second filling line will be delivered on site this summer (summer 2024) and qualified for GMP production in the second quarter of 2025. It will complement the company’s existing multi-use filling line, bringing the company’s total filling capacity to 140 million units per year. In addition to the new filling line, INCOG recently added automated visual-inspection capabilities and will soon complete qualification of equipment to support auto-injector device assembly services.  In March of 2023, INCOG secured an additional $75 million of funding to initiate these expansion efforts. 

Selkirk Pharma. In February (February 2024), Selkirk Pharma announced the aseptic process simulation qualification of its sterile manufacturing facility and newly available fill–finish capacity in Spokane, Washington. The facility operates with technology, including unidirectional material and personnel flow, single-use systems, SKAN isolator technology, and VarioSys advanced dose-filling systems.

Berkshire Sterile Manufacturing. Berkshire Sterile Manufacturing announced plans last year (2023) to double its lyophilization capacity for its automated, isolator-based filling line. A second lyophilizer will be added to the line to increase capacity to 70,000 10R vials per run. The company expects to lyophilize GMP lots on the new lyophilizer by the fourth quarter of 2025.

Oncomed Manufacturing. Oncomed Manufacturing, a member of CDMO Medac Group based in Brno, Czech Republic, is commissioning a new line for the production of syringes. The line will complement two vial lines that are already well established. The new line will boost production capacity, enabling the manufacture of over 100 million of 1-mL long syringes per year.

The production line possesses the capability to accommodate small molecules, both high- and low-potent as well as large molecules. Besides small-volume production, which utilizes formats ranging from 0.5 to 3 mL, its capabilities extend to the manufacturing of large-volume syringes, specifically up to 20 mL and 50 mL.The investment into the new production line and automatic optical inspection line provides the company the ability to meet the growing demand for syringes and to expand Oncomed´s product portfolio. The line will be operational in 2024 with the first product and will offer free capacity from 2025.

Ten23 health. Ten23 health is adding an aseptic large-scale pre-filled syringe vial and cartridge filling line at its site in Visp, Switzerland, which is slated to be GMP operational by the end of 2024, for the aseptic manufacturing of commercial and clinical pharmaceutical sterile products.

NovaCina. In April 2023, Bridgewest Group, an investment firm, completed the acquisition of a sterile injectables manufacturing facility in Bentley, a suburb of Perth, Australia, from Pfizer and launched a new CDMO of sterile injectable drug products, NovaCina.  The 34,000-square-meter cGMP facility has nine production lines across oncology/high-potency, blow–fill–seal and multi-format vial streams at clinical and commercial scales.

Upperton Pharma Solutions. Upperton Pharma Solutions announced earlier this year (2024) a £5-million ($6.3-million) investment to expand operations into small-scale sterile fill–finish at its site in Nottingham, UK. After completing the build and qualification of a new 50,000-square-foot GMP facility during 2023, this new investment adds an additional 7,000-square-foot sterile manufacturing facility at the company’s Trent Gateway site in Nottingham, the UK. The facility will support the manufacturing of aseptic and terminally sterilized small-volume liquids for parenteral, ocular, and pulmonary delivery. The facility build was scheduled to begin in February 2024, with the facility commissioning and validation to be completed early in the fourth quarter of 2024.

Dalton Pharma Services. In 2023, Dalton Pharma Services announced a strategic expansion of its sterile filling and pharmaceutical manufacturing capacity. The capital expansion plan includes a new cGMP sterile filling line with the flexibility to fill vials, syringes, and cartridges under isolator technology. The sterile fill line, designed to support small-scale commercial manufacturing, is integrated with a cGMP lyophilizer. 

Argonaut Manufacturing Services. Argonaut Manufacturing Services is adding a manufacturing line at its facility in Carlsbad, California, for filling of vials, syringes, and cartridges for clinical and commercial drug products. Argonaut’s added capacity for vials and new capabilities to support syringe and cartridge filling will more than double the capacity of the existing filling line. The new filling line is expected to be GMP-ready for clinical and commercial business in the first half of 2025.

Delpharm. Delpharm, a Boulogne-Billancourt, France-based CDMO of drug products, acquired in late 2023 an injectable drug-development facility in Leiden, the Netherlands from Dr Reddy’s Laboratories. This facility employs 40 personnel and is in a 3,500-square-meter unit, equipped with technologies to develop injectable formulations for small and large molecules and to manufacture small batches for clinical trials.

Ardena. Late last year (2023), Ardena, a CDMO of drug substances and drug products, was granted a GMP license by the Belgian Federal Agency for Medicines and Health Products for its new aseptic fill–finish facility in Ghent, Belgium.

Note: currency conversions are as of the time of the news announcement.

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