The CDMO/CMO Report: Parenteral DrugsBy
Increased demand in biologic-based drug development is a key factor driving demand for parenteral drug manufacturing. What are key trends and expansions by CDMO/CMOs in parenteral drug manufacturing? DCAT Value Chain Insights rounds up the latest developments among CDMO/CMOs.
Recent expansion projects
A roundup of recent expansion activity of CDMOs/CMOs for parenteral drugs, announced in 2021 and to 2022 to date (November 1, 2022) is outlined below.
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 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.
Curia. Last month (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.
Last year (August 2021), Curia completed its acquisition of Integrity Bio, a Camarillo, California-headquartered CDMO of biologics formulation development and fill–finish manufacturing services. The addition of Integrity Bio’s two California locations enhanced its drug-product formulation development capabilities and expanded its fill-finish network, which also includes three center-of-excellence facilities in the following: Albuquerque, New Mexico; Burlington, Massachusetts; and Glasgow, Scotland.
Vetter. Vetter, a Ravensburg, Germany-headquartered CDMO of aseptic filling and packaging, late last month (October 2022) commissioned a new EUR 20-million ($20-million) warehouse for packaging materials. The new storage facility includes 7,700 square meters of logistics space consisting of 1,200 square meters for incoming and outgoing goods and 6,500 square meters of room-temperature storage with the capacity for more than 16,000 pallets and a shelf height of 14 meters. The high-bay warehouse is equipped with automated forklifts and six positions for trucks on a receiving area ramp connected to the transfer area. Four driverless shuttles connect the transfer area with the building’s shelves while four driverless forklifts operate between them.
Also, in July (July 2022), Vetter reported that it had completed the first customer fills at its clinical manufacturing facility in Rankweil, Austria. It reported that further batches are already planned, and more customer projects are in the business pipeline. In addition, the site is being expanded to optimize processes and increase production capabilities. Vetter had purchased the approximately 10,000-square-meter manufacturing facility in the middle of 2020. The Rankweil site represents the company’s European counterpart to its existing clinical manufacturing site near Chicago, and increases the company’s capacity for process development as well as clinical manufacturing of Phase I and II injectables.
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 was slated to be operational for commercial production in the third quarter of 2022.
Earlier this year (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 five 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 by 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.
In addition, in 2021, Recipharm announced an investment in a new fill–finish facility in Uttarakhand, India, on a greenfield site near Dehradun in Uttarakhan. It is a joint project between Recipharm and the Sobti family, which include the co-founders of Nichepharm, a CDMO of sterile-manufacturing services.
WuXi STA. Earlier this year (January 2022), WuXi STA, a CDMO of drug substances and drug products and a subsidiary of WuXi AppTec, launched a parenteral formulation manufacturing line at its site in Wuxi, China. The automatic sterile manufacturing line operates in a full isolation system with an annual capacity of 2 million units and features multiple filling modules and a built-in lyophilizer to fill vials, syringes, and cartridges at a full range of sizes and to produce lyophilized powders. In addition to the launch of its parenteral formulation manufacturing line, a second sterile filing line with an annual capacity of 10 million units was scheduled to start operation in the third quarter of 2022 at the same site.
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.
PCI Pharma Services. In May (May 2022), PCI Pharma Services, a CDMO of drug products and contract provider of packaging services, announced it is investing $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 includes a 50,000-square-foot facility, which will allow PCI to expand its biologics packaging and specialty manufacturing within a multi-product facility. The building will include an aseptic fill–finish line with a fully isolated containment system and have 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.
The company currently has an 80,000 square-foot, large-scale filling facility and a 200,000 square-foot finishing center in Grand Rapids. The pact supports the build-out of a second floor in its aseptic filling facility, along with a 30,000-square-foot expansion of its finishing center, including a sterility laboratory and added warehouse space. The agreement will increase GRAM’s filling capacity to a total of four isolator fill lines and further expands finishing operations. This agreement stems from GRAM’s participation in Operation Warp Speed, the US government’s program for developing and manufacturing COVID-19 vaccines and therapeutics, where GRAM provided fill–finish services in the manufacturing of a COVID-19 vaccine.
Earlier, 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 (April 2022), will add more filling and finishing capacity and is scheduled to be completed in 2024.
Catalent. As part of a $350-million expansion of biologics drug substance and drug-product manufacturing capacity at its site in Bloomington, Indiana, Catalent announced earlier this year (2022) that it is adding to its drug product fill–finish capacity, with new syringe-filling lines under barrier isolator technology and additional lyophilized vial capacity. This expansion is expected to be completed in 2024.
In 2021, Catalent invested $50 million to install an additional high-speed vial filling line at its facility in Bloomington, Indiana. It also recently invested $30 million at its facility in Limoges, France, to create a European center of excellence for clinical biologics, formulation development, and drug-product fill–finish services. The expansion began in September 2020 and was completed earlier this year (2022).
Thermo Fisher Scientific. Over the last two years, Thermo Fisher has added 13 sterile drug-product lines for liquid and lyo filling across its global sites and expanded product development services at its sites in Ferentino, Italy, and Greenville, North Carolina. In 2022, the company expanded into Asia-Pacific with an integrated biologics drug-substance and sterile drug- product manufacturing facility in Hangzhou, China, and with a sterile manufacturing facility for large-scale commercial capacity and high-speed filling in Singapore.
Lonza. Lonza is adding an additional aseptic flexible filling line for clinical supply of drug products at its facilities in Stein, Switzerland. The new line will support liquid and lyophilized vial filling and processing, cartridges and pre-filled syringes. The installation is expected to be completed in 2023. This expansion is accompanied by a footprint extension of its Drug Product Services facilities for parenteral dosage forms in Basel, Switzerland. The expansion will support development of early- and late-stage products and increase process development and characterization capabilities offered from the site. Th new Drug Product Services facilities in Basel are expected to be operational in 2024.
In addition, in 2021, Lonza announced it was establishing drug-product manufacturing services at its site in Guangzhou, China. The investment will fund the installation of an aseptic drug-product fill–finish production line at the company’s 17,000–m2 mammalian-cell biomanufacturing facility to provide a combined drug-substance and drug-product manufacturing service offering at the site. The sterile, multi-product fill–finish production line will support the filling of liquid and lyophilized products for clinical trials and commercial batches. The installation was slated to be completed this year (2022).
Carbogen Amcis. Carbogen Amcis, a Bubendorf, Switzerland-based CDMO of active pharmaceutical ingredients (APIs) and drug products, is building a new facility in Riom, France, for the development and manufacture of parenteral drug products. The facility will allow for the handling of complex formulations, including a range of different types of APIs, including highly potent compounds, and supply clinical batches up to Phase III and small-scale commercial projects. There will be two automated lines: the first one for both liquid filling plus lyophilization and the second one dedicated to liquid forms. In addition, development and analytical laboratories will be incorporated to support customer projects. Construction of the facility began in January 2021, and operations are scheduled to begin during the first quarter of 2023.
Alcami. In March (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.
In addition, in January (January 2022), Alcami announced a $10-million investment to expand its laboratory operation in Durham, North Carolina. The investment adds over 6700 ft² to the existing laboratory footprint, new equipment, and capabilities to enhance drug-substance and drug-product characterization capabilities for biologics in all phases of development and the capacity to support parenteral manufacturing projects and stand-alone analytical clients.
Alcami also announced last year (2021) a $31-million investment to expand its sterile development and manufacturing operations at its site in Charleston, South Carolina. The investment will add 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. The new equipment was slated to be qualified and ready for contract cGMP manufacturing this year (2022).
Alcami had earlier completed a $17-million expansion at its site in Charleston with a new 1,000-L cGMP compounding suite. In addition to the new equipment and increased capacity, Alcami also opened a 12,000-square-foot administration complex and a 16,000-square-foot warehouse that was slated to be commissioned in 2022.
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 will start manufacturing from the first quarter of 2023. The Tours facility will be able to produce between 25 million and 30 of millions 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. The investment will enable Delpharm to recruit an additional 20 to 40 people at its Tours site. In addition, in early March (March 2022), the company completed the acquisition of a sterile injectable manufacturing site owned by Sandoz Canada, in Boucherville, Québec.
Fareva. In December 2020, Fareva, a CDMO, and ApiJect Systems, a medical technology company, announced a 10-year licensing agreement to install three blow–fill–seal production lines that when operational, will be able to fill–finish more than 500 million doses per year of vaccines and other large-molecule injectable drugs using ApiJect’s prefilled injector technology. Fareva is investing more than EUR 50M ($56.5 million) for these three manufacturing lines, with support of business development initiatives from the government of France. The new lines will be situated in Fareva Excelvision, located in Annonay, France. The target was to start the first validation batches in June 2022.
Also in 2021, Fareva completed the acquisition of a Novartis’ site in Unterach, Austria. The site specializes in injectable, high-potent drug products, with packaging available in vials and pre-filled syringes. It also acquired a sterile-manufacturing facility in Mirabel, France, from Merck & Co.
WuXi Biologics. Earlier this year (2022), WuXi Biologics, a contract biologics manufacturer, launched a new drug product-manufacturing facility for pre-filled syringes in Wuxi, China. The facility is the company’s ninth drug-product manufacturing facility for vials and prefilled syringes. The facility features an isolator filling line for continuous and steady filling services, which offers multiple volume delivery options for pre-filled syringes. The maximum filling speed can reach 400 PFS/min to support 17 million syringes of drug products manufacturing annually.
In 2021, the comapny launched the GMP operation of its new drug-product facility in Wuxi, China, and a new drug-product packaging center. The 12,000-m2 drug-product facility, called DP2, features an isolator filling line for continuous high-speed production with capacity of up to 60 million vials for commercial drug-production per year.
IDT Biologika. As part of an overall $100-million investment in biologic drug-substance and drug-product manufacturing, IDT Biologika is expanding its fill–finish capacities for 2R, 6R and 10R vials with a further dedicated plant for aseptic liquid filling of late-stage and commercial products up to BSL-2. The line has the capability to fill up to 80 to 100 million 2R vials per year with batch sizes of up to 500,000 2R vials (depending on the bulk volume).
Emergent CDMO. Emergent CDMO has enhanced its drug-product aseptic fill–finish capacity and capabilities at several sites. In 2021, its Camden drug-product manufacturing site in Baltimore, Maryland, began manufacturing operations with new equipment, the Groninger FlexPro 50, which uses isolator-based technology for aseptic processing of pre-sterilized syringes, cartridges, and vials and can support liquid or lyophilized products.
The company’s viral drug-product facility in Rockville, Maryland, is undergoing 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 are slated to begin in the first quarter 2023.
BSP Pharmaceuticals. In 2021, BSP Pharmaceuticals, a Latina, Italy-based CDMO, moved forward with an expansion for an additional filling line for liquid/lyo vials for high-potency and cytotoxic compounds. The new filling ling was planned to be in operational by the second half of 2021 with capacity to produce up to 6.5 million vials. In addition, for non-cytotoxic compounds, the company is expanding with the addition of six filling lines for liquid and lyophilized injectable products plus the implementation of ancillary services, including dedicated utilities, additional warehouse and new development laboratories. The first two lines were slated to be operational in 2021, and the other four will be released within the following two years.
Aenova. Aenova, a Starnberg, Bavaria-based CDMO of sterling manufacturing, expanded its sterile fill–finish capacity at its site in Latina, Italy. The new aseptic production area features a high-speed flexible line for vials and prefilled syringes as well as a compounding area. This area provides capacity for more than 80 million vials and over 180 million prefilled syringes, targeting vaccines and biologics. Further capacity expansions to a total of up to four high-speed filling lines are also being planned. The company also increased ampul capacities at its site in Gronau, Germany.
Samsung Biologics. Samsung Biologics announced plans in 2020 to expand its drug-product capability for aseptic filling by building a flexible filling line and adding two additional lyophilizer units. The filling line was slated to begin operations in the second half of 2021, and the expanded lyophilization line was slated to become operational in the first half of 2022. Through this expansion, Samsung Biologics will add small-scale cartridge- and syringe-filling to its drug-product offerings and increase its total lyophilization capacity.
Ajinomoto Bio-Pharma Services. In 2021, Ajinomoto Bio-Pharma Services opened a new multi-purpose fill–finish line at its commercial manufacturing facility in San Diego, California. The line can accommodate a high-speed process rate to move 22,000 syringes per hour with a batch capacity of over 200 thousand syringes.
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 is scheduled 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.
INCOG BioPharma Services. INCOG BioPharma Services, a CDMO of sterile injectables, opened a new manufacturing facility in Fishers, Indiana, in May (May 2022). The 90,000-square-foot fill–finish manufacturing facility formulates and fills injectable drugs into vials, syringes and cartridges.
ten23 health. ten23 health, a Basel, Switzerland-based CDMO of injectable drugs, reported in September (September 2022) that it had completed the initial phase of construction for a new large-scale sterile manufacturing facility in Visp, Switzerland. The company has completed the construction of the building, and next phase of construction will be for interior setup. 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.
Berkshire Sterile Manufacturing. Berkshire Sterile Manufacturing, a Lee, Massachusetts-based CDMO of injectable drugs, has launched a small-volume sterile filling process. Batches up to 1.1 L of drug product can be processed during fill studies, individual fill volumes remained within 1% of the set dispense volume down to fill volumes of 75 micrograms.
Note: currency conversions are at the time of the expansion announcement.