The CDMO/CMO Report: Expansions in Parenteral Drug MfgBy
Increased demand in biologic-based drug development and for COVID-19 vaccines/drugs is driving demand for parenteral drug manufacturing. Which CDMOs/CMOs are expanding?
Recent expansion projects
A roundup of recent expansion activity of CDMOs/CMOs for parenteral drugs, announced in 2021 and to 2022 to date outlined below.
Baxter BioPharma Solutions. Baxter BioPharma Solutions (BPS), a business unit and CDMO business of Baxter International, announced it 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 begin in 2022 and be completed in 2024. The expansion is in addition to a $50-million expansion to its sterile fill–finish manufacturing facilities in Bloomington, Indiana announced in 2020.
PCI Pharma Services. Last December (December 2021), PCI Pharma Services, a CDMO and contract provider of packaging services, completed its acquisition of LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services. The acquisition adds five facilities in the US (New Hampshire and Wisconsin) and Europe (Spain), with a sixth expecting approval early this year (2022). Prior to the acquisition, LSNE recently expanded its sterile drug-product lyophilization capacity at its parenteral-drug manufacturing facility in Madison, Wisconsin, with the installation of a new lyophilizer.
Alcami. Alcami, a CDMO of drug products and provider of analytical testing services, is investing $31-million 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 will 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 will be commissioned in 2022.
In addition, last month (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.
Catalent. In 2021, Catalent invested $50 million to install an additional high-speed vial filling line at its facility in Bloomington, Indiana. Catalent is also investing $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 with completion anticipated in 2022.
Vetter. Vetter, a CDMO of aseptic filling and packaging, announced last month (January 2022) that it had received manufacturing authorization from the Austrian Agency for Health and Food Safety for its new clinical production site in Rankweil, Austria. 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. Since acquiring the Rankweil site, Vetter has modified and equipped all laboratory, technical, and production areas to quality standards and optimized numerous systems and processes.
In addition, since 2021, all Vetter sites are climate-neutral and no longer have a CO2 footprint. The company’s production sites and sales offices in Austria, the US, and Asia have followed the example of its sites in Germany, where climate neutrality had already been achieved. In 2021, Vetter opened a new business entity in Shanghai, China. The new office, its fourth in the Asia Pacific region, will help increase the visibility of Vetter’s presence in China and underlines its importance as a strategic market to the company.
Thermo Fisher Scientific. Thermo Fisher is investing $154 million to expand its pharmaceutical drug-product manufacturing operations in Greenville, North Carolina. The Greenville facility is a multi-purpose pharmaceutical manufacturing and packaging campus spanning more than one million square feet. This expansion will increase the manufacturing capacity for sterile liquid and lyophilized filling, pre-filled syringes, and solid dose continuous manufacturing. The company is also expanding production capacity at its sites in Swindon, UK, and Ferentino and Monza, Italy. In addition to expansions in North America and Europe, the company has expansion projects in Asia-Pacific, including a new sterile manufacturing facility in Singapore and a new integrated biologics and sterile drug-development and manufacturing site in Hangzhou, China.
To support demand global sterile manufacturing for mRNA vaccines and other advanced therapies, the company expanded its global sterile manufacturing commercial footprint with 12 new sterile commercial and three development lines across four sites in the US and Europe, which became/will be operational in 2021 and 2022.
Grand River Aseptic Manufacturing. In 2021, Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, opened a new finishing manufacturing facility and warehouse center. The building is the company’s fourth manufacturing facility and adds an additional 110,000 square feet to the company’s footprint. In addition, GRAM has invested in advanced finishing equipment, including a new MG America labeling machine with a Dividella packaging line, and two Stevanato automated inspection systems. In 2020, the company completed a $60-million expansion project with the opening of a large-scale fill–finish facility in Grand Rapids, Michigan.
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 DPS 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 is expected to be completed this year (2022).
Curia. Last year (August 2021), Curia (formally AMRI) 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.
Jubilant HollisterStier. Jubilant HollisterStier, a CDMO of sterile manufacturing, is 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.
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.
Fareva. Last December (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 intends to invest 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 is to Annona 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. and Unterach, Austria, respectively.
WuXi STA. Last month (January 2022), WuXi STA, a CDMO and 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 of a full range of sizes, as well as to produce lyophilized powders.
In addition to the launch of its parenteral formulation manufacturing line, the company says a second sterile filing line with an annual capacity of 10 million units is scheduled to start operation in the third quarter of 2022 at the same site.
WuXi Biologics. Separately, in 2021, WuXi Biologics, a contract biologics manufacturer, 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.
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 currently undergoing a 58,000-square foot expansion that will 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. Qualification activities have started with anticipated completion and operations beginning 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.
Recipharm. Last month (January 2022), Recipharm launched construction of its 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 which are forecast to produce more than 100 million units in 2024. These lines will be dedicated to producing vials and vaccines in syringes. 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 investment in a new fill–finish facility in Uttarakhand, India, The facility was constructed on a greenfield site near Dehradun in Uttarakhand and is a joint project between Recipharm and the Sobti family, which include the co-founders of Nichepharm, a CDMO of sterile-manufacturing services.
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 capity 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 will 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. In 2021 (November 2021), Selkirk Pharma, a Spokane, Washington-based CDMO, executed a purchase-and-sale agreement to acquire 10.7 acres of land adjacent to its facility in Spokane to expand its fill–finish campus. The company, which launched operations in 2019, specializes in the fill–finish of injectable drugs. The land acquisition expands the Selkirk campus to more than 27 acres, which provides space for three standalone factories. Selkirk’s first plant (Plant 1), a 145,000-square-foot facility, is under construction and is slated to be completed in March of 2022. The newly acquired 10.7-acre site will serve as the location for Selkirk’s third plant.
INCOG BioPharma Services. INCOG BioPharma Services, a recently formed CDMO of sterile injectables, reported last month (January 2022) is nearing completion on the construction of new 90,000-square-foot manufacturing facility and global headquarters in Fishers, Indiana. The facility will support early-phase clinical projects to commercial-scale manufacturing. INCOG BioPharma Services was founded in 2020 and purchased the land for new facility in December 2020.
In addition, the company will be offering development, analytical testing, stability studies, and storage (including cold-chain storage) starting in the first half of 2022 and will be fully operational and will begin offering cGMP manufacturing in the third quarter of 2022.
Note: This article was updated with further information from WuXi STA, Emergent CDMO, and INCOG BioPharma Services.