Parenteral Drugs: CDMO/CMOs Expanding

Parenteral drugs have accounted for between 40% and 50% of new drug approvals over the past five years. CDMOs/CMOs continue to expand.

Parenteral drugs have accounted for between 40% and 50% of new drug approvals over the past five years. CDMOs/CMOs continue to expand.

Active area of investment

Key expansion activity in parenteral drug manufacturing announced by CDMOs/CMOs thus far in 2021 is outlined below.

Baxter BioPharma Solutions. Earlier this month (November 2021), 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 expected 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 last year (2020).

PCI Pharma Services. Last month (October 2021), PCI Pharma Services, a CDMO and contract provider of packaging services, agreed to acquire 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 over the coming months (as reported on October 12, 2021), and three additional facilities under development, to advance PCI’s global 30-site network.

Additionally, LSNE has expanded its sterile drug-product lyophilization capacity at its parenteral-drug manufacturing facility in Madison, Wisconsin, with the installation of a new lyophilizer. The Madison capacity increase is one step in a company-wide lyophilization expansion plan, adding capacity to all existing facilities. LSNE’s new 120-square-foot commercial lyophilizer is equipped with systems to protect active pharmaceutical ingredients and doubles the lyophilization capacity at the site.

Alcami. Alcami, a CDMO of drug products and provider of analytical testing services, announced last month (October 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 will be qualified and ready for contract cGMP manufacturing in 2022.

Alcami previously invested $17 million at its site in Charleston to expand development and manufacturing capacity 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.

Catalent. In 2021, Catalent invested $50 million to install an additional high-speed vial filling line at its facility in Bloomington, Indiana. By the end of 2021, the site will have high-speed filling capacity across three vial lines, two syringe lines, and a flexible line capable of filling vials, syringes, or cartridges. The facility has expertise in sterile formulation, drug-substance development and manufacturing, and drug-product fill-finish capacity, including primary and secondary packaging.

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, reported earlier this year (2021) that all systems and manufacturing processes at its clinical production site in Rankweil, Austria, have been integrated as it targets manufacturing licensure later in 2021. The facility expands the company’s European footprint and is a counterpart to its existing US clinical manufacturing site near Chicago. The site provides early clinical development to support Phase I and Phase II projects.

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 was already achieved in the past year.

Also in 2021, Vetter opened a new business entity in Shanghai, China. The new office, now 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 Vetter. Thus, the office will support customer relations and aid in the development of new business.

Thermo Fisher Scientific. Thermo Fisher Scientific 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.

Grand River Aseptic Manufacturing. Earlier this year (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 GRAM’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 making an investment to establish 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 in 2022.

Curia. Curia (formally AMRI) acquired Integrity Bio, a CDMO of biologics formulation development and fill–finish manufacturing services, which recently expanded its facilities to include a second fill-finish line that more than doubled its manufacturing capacity. Curia also provides formulation development through fill-finish commercial manufacturing across three center-of-excellence facilities in 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 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. In 2020, Fareva completed the acquisition of two sterile-manufacturing sites in Idron, and Saint Julien-en-Genevois, France, from Pierre-Fabre Group. The Idron, France site is dedicated to the manufacture of sterile injectable forms (pre-filled syringes and lyophilized and liquid-filled vials). The facility has 10 commercial lines and a pilot plant that is slated to be operational in 2022. The core business of the site is to handle highly potent and biologics entities. The site in Saint Julien-en-Genevois manufactures monoclonal antibodies and conjugated monoclonal antibodies with high potent actives. Last November (November 2020), Fareva announced negotiations with Merck & Co. and Novartis to acquire two sterile-manufacturing sites in Mirabel, France and Unterach, Austria, respectively.

BSP Pharmaceuticals. BSP Pharmaceuticals, a Latina, Italy-based CDMO, is proceeding 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 and will add sufficient 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 all the 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. Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has invested in a new facility in Uttarakhand, India, to increase its fill-finish capacity increase to one billion sterile units per year. The facility was constructed on a greenfield site near Dehradun in Uttarakhand and is a joint project between Recipharm and the Sobti family. The new site, which is designed for approval by US and European Union regulatory authorities, is ready to begin production following approval from local authorities. It will deliver ampoules, vials filled with liquid and powder, lyophilized vials, dental cartridges, and pre-filled syringes. The next step for the project will be to obtain authorization from European regulatory authorities.

In addition, Recipharm signed a memorandum of understanding with the Moroccan government and a consortium of the country’s banks to operate a new fill-finish factory in Morocco. The factory is planned to be operational by 2023 and will mirror Recipharm’s new fill-finish line at its facility in Monts, France, on a larger scale. Approximately $500 million will be invested by the Moroccan government and consortium over the next five years (as reported on July 6, 2021) to establish both capacity and capability for the manufacturing of vaccines and biotherapeutics in Morocco.

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 aso increased ampul capacities at its site in Gronau, Germany.

WuXi Biologics. 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.

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. 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 rated to move 22,000 syringes per hour with a batch capacity of over 200 thousand syringes. The line became fully operational in 2021.

Selkirk Pharma. Selkirk Pharma, a Spokane, Washington-based CDMO, has 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.

Recent Feature Articles

Supply Chains: Trends in Chemical Distribution

Distributors of chemicals, pharma ingredients, and other materials used in bio/pharma development and manufacturing play a crucial role.  With increased product and supply chain complexity, DCAT Value Chain Insights examines the key trends and issues impacting markets and supply chains.

Drugs Shortages Once Again in the Spotlight

Earlier this month, the FDA published its annual report to Congress detailing the level of drug shortages and efforts the agency is taking to mitigate them. In 2023, 55 new drug shortages were identified by the FDA. What products and areas were most prevalent and what is the impact on drug manufacturers? 

The CDMO/CMO & Suppliers’ Report: The Rising Strength of Tides

Double-digit growth is projected for the markets for peptide and oligonucleotide synthesis, creating opportunities for CDMOs/CMOs.

The Financial Squeeze on Emerging Pharma and Early-Stage Innovation

Access to public or private funding remains an existential challenge to fuel early-stage innovation as the biotech industry seeks to recover from a constrained financial & deal-making environment.