The CDMO/CMO Report: Parenteral Drugs
Increased demand in biologic-based drug development is a key factor driving demand for parenteral drug manufacturing, and CDMOs/CMOs are responding with recent investment to expand capacity. DCAT Value Chain Insights rounds up the latest developments among CDMO/CMOs.
A roundup of recent expansion activity of CDMOs/CMOs for parenteral drugs, announced in 2022 and 2023 to date (April 7, 2023) is outlined below.
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.
Catalent. Catalent is expanding packaging and pre-filled syringe capabilities at its facility in Anagni, Italy, to support late-phase clinical and commercial sterile injectable programs. The latest expansion includes the addition of a new high-speed syringe-filling line under isolator at its site in Anagni, Italy, which is scheduled to be GMP-ready in mid-2023. The company is also adding two new high-speed syringe-filling lines under isolators at its site in Bloomington, Indiana, which is expected to be GMP-ready in 2024.
Thermo Fisher Scientific. Thermo Fisher Scientific recently opened an 86,000-square-foot cGMP facility in Hangzhou, China, its first integrated biologics drug-substance and sterile drug-product manufacturing site. From there, the company can support pharmaceutical and biotechnology companies in China, enhance access to China for companies outside that country, and make those capabilities available for global needs. Furthermore, Thermo Fisher will open its first site in Singapore later this year (2023) for large-scale commercial capacity and high-speed filling of vials, which will expand its global investment in vaccine capabilities.
WuXi STA. In 2023, WuXi STA, a CDMO of drug substances and drug products and part of WuXi Apptec, launched two parenteral commercial production lines at its site in Wuxi City, China, with capacity of 12 million units for a variety of dosage forms and filling formats. The site also launched a lipid nanoparticle (LNP) platform to provide integrated lipid discovery, formulation & process development, and GMP manufacturing services. Next year (2024), the site will launch a high-potency parenteral line with an occupational exposure limit of 10 ng/m3 and annual capacity of 10 million units. At the company’s site in Couvet, Switzerland, over the next two years, the company plans to add a parenteral line following recent and planned expansions in solid-dosage forms.
Baxter BioPharma Solutions. Baxter BioPharma Solutions, a business unit and CDMO business of Baxter International, is investing approximately $100 million to expand its sterile fill–finish manufacturing facility in Halle/Westfalen, Germany. Construction on the new manufacturing building is slated to be completed in 2024. The expansion is in addition to a $50-million expansion to its sterile fill–finish manufacturing facilities in Bloomington, Indiana, which the company announced in 2020.
CordenPharma. At its site in Italy, CordenPharma Caponago (Italy), CordenPharma, is investing EUR 30 million ($33 million) into a new commercial aseptic filling line with isolator technology. The expansions started in the first quarter of 2023, with completion slated for the second half of 2024.
Curia. In October 2022, Curia broke ground to expand its site in Albuquerque, New Mexico, to add additional space for a high-speed fill–finish vial line that will provide Biosafety Level 2 containment. The expansion also includes two lyophilizers and a flexible filling line for vials, syringes, and cartridges to support smaller-batch advanced therapies. The flexible filling line and high-speed fill-finish vial line are planned to be operational in 2025. The expansion is part of an agreement with the US government to support the domestic production of injectable medicines.
Vetter. Vetter, a CDMO of aseptic filling and secondary packaging, provided an update of its clinical-scale development and manufacturing facilities in the US and Europe. Its facility in Skokie, Illinois, which has contributed to bringing five new customer products to market since it began full operations, has another four products expected to launch in the next months.
Since the opening of the site, more than 240 customer audits have been successfully completed, and the facility has performed over 45 media fills without failure. Currently, Vetter Development Service runs more than 80 projects in Phase I and II clinical development. In the past years, the facility executed over 30 transfers from its early clinical projects to the company’s site in Germany for further late-stage development.
In addition, the company’s newest clinical manufacturing site in Rankweil, Austria, has increased the company’s capacity in process development as well as clinical manufacturing of Phase I and II injectables. Purchased by Vetter in 2020, the facility received its manufacturing authorization at the end of 2021 and successfully completed its first customer fills beginning last year (2022). Vetter Development Services Austria acts as a European counterpart to its site in Skokie. Since its opening, the site has won 14 projects and more are in the pipeline.
Separately, last month (March 2023), Vetter reported that it became a member of the UN Global Compact, an United Nations-based corporate sustainability initiative by which companies commit to aligning and documenting their corporate actions to 10 defined principles relating to the enforcement and implementation of human and employee rights, environmental protection, and the prevention of corruption.
Recipharm. Recipharm, a Stockholm, Sweden-based CDMO of drug substances, drug products and drug-delivery devices, is investing in a new high-speed filling line for pre-filled syringes and cartridges at its facility in Wasserburg, Germany. It is also invested in low-volume blow–fill–seal (BFS) filling capabilities at its facility in Kaysersberg, France. The new high-speed filling line for pre-filled syringes and cartridges at its facility in Wasserburg is expected to be ready for technical trials by April 2023 with the first GMP batch run in May 2023.
Separately, the company is applying its Lab+ technology to enable a throughput speed of 2,000 doses per hour for BFS projects with smaller volumes at its facility in Kaysersberg, France. The new Lab+ technology supports proof-of-concept, feasibility batches (cGMP & non-cGMP) and clinical Phase I and Phase II batches and can be adapted for a range of different product types and dosage designs. The system can also be charged with formulation using both conventional stainless-steel vessels or single-use charge bags from 200 mL up to 20 L.
Recipharm is also investing to expand its sterile fill–finish production capabilities at its site in Monts, France. The manufacturing facility, which specializes in the aseptic filling into vials and cartridges, currently has three lines for vials. The investment will expand the company’s manufacturing footprint by adding a high-speed filling line that is able to fill 400 vials a minute, with the capacity for more than 100 million vials per year. The new line became operational for commercial production in the third quarter of 2022.
Earlier in 2022 (January 2022), Recipharm launched construction of a new fill–finish factory in Morocco. The facility is being funded by the Moroccan Government, a consortium of banks, and Recipharm over the next several years to establish both capacity and capability for Recipharm to manufacture vaccines and therapeutics in Morocco and the rest of Africa. The facility, called SENSYO Pharmatech, will focus on the manufacture and syringing of vaccines and will feature three industrial lines that will be capable to produce more than 100 million units in 2024. It is being constructed on a 60-hectare greenfield site and is expected to be operational in 2023. Between 2022-2025, the aim is to transfer the aseptic filling and active substance manufacturing of more than 20 vaccines and biotherapeutic products, including three COVID-19 vaccines, to meet demand in Morocco and Africa.
Siegfried. During the last two years, Siegfried has invested in its biologics fill–finish capacities at its site in Hameln, Germany, and now has six different vial lines (ready-to-use [RTU] and vials), online visual inspection, and a packaging line as well as a fully equipped new formulation and analytical department. The company’s expertise spans higher-volume vaccines for COVID-19 and low-volume high-value biologics in Phase I and Phase II development.
Also, the company has completed the integration of two Novartis sites, near Barcelona, acquired in 2021, to achieve critical mass in drug products with five sites worldwide offering a broad range of development and manufacturing services for oral, inhalative, and aseptic formulations for both small and large scales. Within two years, the company successfully integrated the two new sites in Barcelona and transformed them from captive use to a multiclient-facing CDMO. As a concluding part of the integration, the company recently inaugurated a new Development Center for Drug Products at the two Barcelona sites.
Carbogen Amcis. Carbogen Amcis, a CDMO of drug substances and drug products, opened a new 9,500-square-meter facility in Saint-Beauzire, France, for sterile liquid and freeze-dried drug-product manufacturing earlier this year (February 2023). The new facility has two automated production lines designed to handle liquid and lyophilized forms, including potent compounds and antibody drug conjugates.
Jubilant HollisterStier. Jubilant HollisterStier, a CDMO of injectable drugs, is investing CAD$100 million (US$77 million) to modernize and augment production capacity by over 100% at its drug-product manufacturing facility in Montreal, Canada. The company will also acquire new equipment, including for a single-use sterile preparation room to maximize the filling process linked to the production of liquid sterile products. The company is also investing $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, Washington. The investment is being made to set up an injectable fill line with isolator technology and will also include two 300-square-foot lyophilizers. This expansion will be spread over 50,000 square feet and will be commercially operational by the end of 2024.
In addition to the $92-million investment in its Spokane facility, the company has partnered with the US government in a $193-million project to double the company’s injectable filling production capacity at its facility in Spokane. This expansion is slated to be completed by 2025. The total cost of the expansion is $193 million with the US government contributing $149.6-million.
WuXi Biologics. n November 2022, WuXi Biologics, a CDMO of biologics drug substances and drug products, launched an integrated contract research, development, and manufacturing center in Fengxian, Shanghai, China. The 1.6-million-square-foot Integrated Biologics CRDMO Center is built with global cGMP standards and can accommodate more than 3,000 employees. The grand opening included research, development, one drug-substance manufacturing facility, and two drug-product facilities for clinical manufacturing at various scales and volumes. Once fully operational, it will be able to provide services from early discovery to commercial manufacturing, all within the center.
BSP Pharmaceuticals. BSP Pharmaceuticals, a Latina, Italy-based CDMO of cytotoxic and non-cytotoxic products, is proceeding with a new cycle of investment that will include a new sterile suite in full containment for sterile liquid and lyo vials. Three additional sterile suites in full containment are planned to be built for the manufacturing of sterile liquid vials (non-cytotoxic projects) for biologicals and small molecules for immuno-oncology and immunotherapy projects.
PCI Pharma Services. In May (May 2022), PCI Pharma Services, a CDMO of drug products and a contract provider of packaging services, invested $100 million to expand its capabilities and capacity in aseptic liquid fill–finish and sterile lyophilization technology at its campus in Bedford, New Hampshire.
Following its acquisition of LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services in December 2021, this expansion plan included a 50,000-square-foot facility, to expand its biologics packaging and specialty manufacturing within a multi-product facility. The building includes an aseptic fill–finish line with a fully isolated containment system and twin lyophilizers with auto-loading and unloading systems, with the capacity to complete 400 vials per minute on a sterile fill–finish line.
Grand River Aseptic Manufacturing. Grand River Aseptic Manufacturing (GRAM), a CDMO of parenteral drug products, announced in April (April 2022) a $160-million investment to fund the expansions of its fill–finish facilities in Grand Rivers, Michigan, which includes a $120-million multi-year contract with the US Department of Health and Human Services and the US Department of Defense.
In 2022, GRAM completed Phase II of an expansion of its Grand Rivers facility to include the installation of two new sterile filling lines. Phase III of its facility expansion, which the company announced in April 2022, will add more filling and finishing capacity and is scheduled to be completed in 2024.
INCOG BioPharma Services. INCOG BioPharma Services a Fisher, Indiana-based CDMO specializing in sterile injectables, is increasing injectable drug-product filling capacity at is site in Indiana. Having invested $100 million to date and having launched cGMP filling operations on a multi-use line in early 2023, INCOG BioPharma’s next expansion plan includes adding a second cleanroom formulation suite and filling suite, equipped with a high-speed syringe/cartridge filling line. In addition, the company plans to procure an automated inspection machine and device-assembly equipment to support a growing pipeline of syringe projects. This next expansion phase results in total investment nearing $200 million. The company’s next capital improvement project increases its parenteral drug-product filling capacity by 2.5x to 125 million units (currently, now 40 million units/year with the already installed Optima Multiuse line) with the addition of a new high-speed syringe/cartridge filling line.
Alcami. In March 2022, Alcami, a CDMO of drug products and provider of analytical testing services, added a formulation-development laboratory to support small- and large-molecule programs. The dedicated 3,800-ft² formulation development space is co-located within the same facility as Alcami’s parenteral manufacturing operations, which has isolator filling lines for liquid and lyophilized products. Alcami also completed in 2022 a $31-million investment to expand its sterile development and manufacturing operations at its site in Charleston, South Carolina. The investment added a second production line consisting of a vial washer and depyrogenation tunnel with an isolator filling line containing two lyophilizers. Also, the company invested in enhanced semi-automated visual inspection equipment to support the additional manufacturing capacity.
Delpharm. Delpharm, a CDMO of drug products, is investing EUR 28 million ($30 million) in a sterile manufacturing line for prefilled syringes at its plant in Tours, France. Delpharm started the project in April 2021 to add a new building and was slated to begin manufacturing from the first quarter of 2023. The Tours facility will be able to produce between 25 million and 30 million syringes per year. The plant will provide glass, plastic, subcutaneous, intra-nasal and oro-mucosal prefilled syringes with formats from 1 mL to 50 mL.
In addition, earlier this year (2023), Delpharm acquired 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. In addition, in March 2022, the company completed the acquisition of a sterile injectable manufacturing site owned by Sandoz Canada, in Boucherville, Québec.
Bushu Pharma. Bushu Pharma,a Kawagoe, Japan-headquartered CMO of drug products and a provider of packaging and supply-chain services, has reinforced its “Gateway to Asia” strategy for manufacturing and distribution of bio products for the Asian market by expanding in both filling and packaging. A new filling line applicable for both syringes and vials with single-use concept will be operational in 2025, to provide flexibility for vial / lyo-vial / syringe products. A new packaging center with 1,560 pallets of 2-8 degrees Celsius storage will be launched in late 2023 to extend the company’s capacity for secondary packaging of syringes and auto injectors.
Ascendia Pharmaceuticals. Ascendia Pharmaceuticals is more than doubling its footprint at its corporate headquarters in North Brunswick, New Jersey. The expanded 60,000-square-foot facility will include sterile manufacturing with ISO-5 process and filling room space. With the facility expansion, in addition to early-phase clinical trial supply, Ascendia will offer Phase III and commercial supply for production of prefilled syringes, vials, cartridges, and other deliverables at a large scale.
Lifecore Biomedical. Lifecore Biomedical, a CDMO of sterile injectables, is adding one new 10-headed and one new 5-headed filler to expand its aseptic fill–finish capabilities for injectable drugs and medical-device products, to increase the company’s throughput by 50–100 million units. Equipment installation at its suburban campus in Minneapolis, Minnesota, will occur in the July 2023 timeframe and will be cGMP-ready in 2024. This additional capacity expands the company’s in-house capabilities to provide isolator technology as well as clinical/commercial-scale peristaltic pump filling. The machines are flexible and can run various sizes of vials, cartridges, and syringes to increase the company’s capacity for three container/closure types.
NovaCina. Earlier this month (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. The plant will operate as a CDMO under the NovaCina name moving forward and will continue to produce drug products for Pfizer under a master services agreement. The facility has over 400 employees.
Argonaut Manufacturing Services. Argonaut Manufacturing Services, a Carlsbad, California-based CDMO of fill-finish and lyophilization services, is adding a manufacturing line at its Carlsbad facility capable of filling 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.
Emergent CDMO. Emergent CDMO’s viral drug-product facility in Rockville, Maryland, underwent a 58,000-square=foot expansion to include a high-speed fill–finish line with fully integrated isolator technology and an automated inspection, labeling, and packaging line to enable large-scale fill–finish manufacturing of viral biotherapeutics and vaccines. Operations were slated to begin in the first quarter 2023.
Selkirk Pharma. Selkirk Pharma, a CDMO of injectable drugs, is progressing an expansion of its facility in Spokane, Washington. It previously constructed a greenfield facility in Spokane. Two new additional filling lines will be constructed within the previously built gray shell space inside the company’s existing facility. GMP production on Line 1 was slated to begin in the first quarter of 2023. Start of GMP production on Lines 2 and 3 is scheduled for 2025. The two new production lines are functional replicas of Selkirk’s Line 1, each with flexible filling systems capable of filling both vials and syringes. All three production lines will have lyophilization capabilities as well. Each line is capable of producing 15 million units annually, for a plant capacity of 45 million units.
ten23 health. ten23 health, a Basel, Switzerland-based CDMO of injectable drugs, reported in September 2022 that it had completed the initial phase of construction for a new large-scale sterile manufacturing facility in Visp, Switzerland. When complete, the facility will have two sterile production lines and 5,000 square meters of space, with 30 million units/year of fill–finish commercial and clinical capacity.The facility is expected to be operational in 2024.
Note: currency conversions are at the time of the expansion announcement.