AGC Biologics To Invest $194 M To Expand Biomanufacturing Capacity; Piramal, MilliporeSigma Announce ExpansionsBy
The latest from CDMOs, CMOs, and suppliers featuring AGC Biologics, Piramal Pharma Solutions, MilliporeSigma, Recipharm, Catalent, Thermo Fisher, Evonik, and others.
Chemical/Chemical API Manufacturing
Piramal To Invest $32 M for API Mfg Expansion
Piramal Pharma Solutions (PPS), a CDMO of active pharmaceutical ingredients (APIs) and drug products, is investing approximately $32 million to expand its facility in Riverview, Michigan with additional capacity and new services for the development and manufacturing of active pharmaceutical ingredients (APIs).
This expansion will consist of more than 25,000 square feet, which includes 8,500 square feet of production space. Capacity will increase in large-scale manufacturing with the addition of new reactors capable of handling up to 4,000 L. PPS is also adding two new kilo labs for process development and manufacture for clinical trials at scales up to 100 L as well as new equipment that designed to handle potent compounds. Facility-design procedures include controlled-room pressurizations with air locks, glovebox technology/contained systems for charging and discharging of potent compounds, and a scrubber to address any reaction off-gassing.
The expansion is planned to be ready beginning in the summer of 2022 and is expected to add approximately 20 new hires to the site, which would bring the total headcount at the site to more than 180 employees.
Source: Piramal Pharma Solutions
Recipharm To Invest $2.5 M To Expand Clinical-Scale API Mfg
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has announced it will invest $2.5 million to expand clinical GMP capacity for active pharmaceutical ingredients (APIs) at its facility in Israel.
The investment will see the implementation of a full chemical unit, including a number of new R&D laboratories and technologies. The expansion is expected to be fully operative by the end of 2021.
Recipharm’s facility in Israel is located south of Tel Aviv in the vicinity of the Weizmann Science Park and specializes in medicinal chemistry, which includes chemical synthesis and analytical services.
AGC Biologics To Invest $194 M To Expand Biomanufacturing Capacity
AGC Biologics, a contract biologics manufacturer, has announced it will invest approximately EUR 160 million ($194 million) to expand the production capacity of its Copenhagen, Denmark facility.
AGC Biologics will construct a new building on land adjacent to its current Copenhagen site and add production floors with 2, 000L single-use bioreactors, labs and office space. This expansion will more than double AGC Biologics’ single-use bioreactor mammalian cell-culture capacity in Copenhagen. The new building will have a total floor area of approximately 19,000 m2.
The expansion is slated to begin operations is 2023.
Source: AGC Biologics
MilliporeSigma Expands Mfg Capacity with $47-M Investment
MilliporeSigma has announced an expansion of its manufacturing capacity at its production facilities in Danvers, Massachusetts, and Jaffrey, New Hampshire with a combined $47-million investment.
The Danvers expansion will add 65,000 square feet of space to the site’s single-use assembly operations and add to the existing 120,000-square-foot facility. The expansion will add the capacity needed to support the manufacturing of products across several portfolios, including MilliporeSigma’s Mobius single-use consumables. The total investment in Danvers is about $25 million and will add approximately 400 jobs throughout 2021.
The Jaffrey expansion plans include adding 25,000 square feet to the existing 260,000-square-foot facility. The additional capacity includes new production lines and equipment to support the manufacturing of filtration devices and membrane products, specifically Durapore filters, Express filters, and the Viresolve product lines. The total investment in Jaffrey is about $22 million. This expansion is expected to bring nearly 275 roles by 2022 once the expansion is completed
These expansions join MilliporeSigma’s investments announced in 2020 to further enhance services and manufacturing capacity at its site in Buchs, Switzerland; Carlsbad, California; Madison, Wisconsin; and Darmstadt, Germany.
Samsung Biologics Names New President, CEO
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has appointed John Rim, the company’s former Executive Vice President, as the new President and Chief Executive Officer (CEO) of the company.
Rim joined Samsung Biologics in September 2018 and has led business operations at one of the company’s plants in Incheon, South Korea. He has more than 35 years of industry expertise and experience in biopharmaceuticals and has served in senior leadership roles in manufacturing, sales, and development with Genentech/Roche.
Source: Samsung Biologics
Formulation Development/Drug-Product Manufacturing
Thermo Fisher To Expand Sterile Drug Product Development, Mfg
Thermo Fisher Scientific has announced it will further expand its footprint in North America and Europe for sterile drug-product development and commercial manufacturing.
The company is currently expanding the following sites: Greenville, North Carolina; Swindon, UK; and Ferentino and Monza, Italy. These investments will add 15 development and commercial production lines as well as supporting a range of services, including live virus, aseptic liquid, and lyophilized vial filling. These projects are expected to be completed over the next two years (as reported on December 9, 2020) and will create approximately 1,000 jobs.
In addition to expansions in North America and Europe, the company recently announced 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.
Source: Thermo Fisher Scientific
Catalent Investing $10 M in High-Potency Containment Capabilities
Catalent is investing $10 million at its sites in Malvern, Pennsylvania and Dartford, UK, to expand its micronization capabilities to add isolator capabilities for highly potent drug compounds.
The investment will allow flexible jet milling operations to be carried out at both sites under containment to a working occupational exposure limit of 0.05 micrograms per cubic meter to enable micronization of potent and highly potent compounds.
Work is underway at both facilities, with installation and validation activities likely to be completed by mid-2021.
The Dartford and Malvern sites provide particle-size reduction services including micronization, jet milling, mechanical milling, cryogenic milling, and associated analytical services, and work alongside Catalent’s network of commercial-scale facilities.
Evonik To Acquire Absorbable Polymers Product Line for $15 M
Evonik, a specialty and fine chemicals producer, has agreed to acquire the Lactel biodegradable polymers business from Durect Corporation, a biopharmaceutical company with proprietary drug-delivery technology, for $15 million.
Under the agreement, Evonik will pay Durect $15 million in exchange for certain assets and liabilities associated with Lactel product line based in Birmingham, Alabama, plus an additional potential payment based on full year EBITDA (earnings before interest, taxes, depreciation, and amortization) results.
The transaction is expected to close by the first quarter of 2021, pending the satisfaction of certain customary closing conditions. An offer will be extended to each of the 15 employees of Durect located in Birmingham, Alabama, which are associated with the Lactel business to transition to Evonik.
Source: Evonik and Durect Corporation
Colorcon Invests in i2O Therapeutics
Colorcon Ventures, the corporate venture fund of Colorcon, a developer of film-coating systems and excipients, has made a strategic investment in i2O Therapeutics, a Boston-based company focused on developing oral formulations of injectable drugs.
i2O is a start-up company founded by researchers from Harvard. Its initial focus is on developing an oral formulation for GLP-1 analogs.
In addition to this investment, Colorcon will collaborate with i2O to accelerate i2O’s research and development efforts. i2O previously announced a seed round of financing led by Sanofi Ventures and JDRF, a diabetes research and advocacy organization.
Source: Colorcon and i2O Therapeutics
Tjoapack To Invest $12-M in Packaging, Supply Facility
Tjoapack, a North Brabant, Netherlands-based contract packaging organization, has announced a EUR 10 million ($12 million) two-year investment in its packaging and supply chain facility in Etten-Leur, The Netherlands.
The investment will fund an expansion of the facility from 8,400 square meters to 11,500 square meters and the addition of eight new production lines to double capacity for primary packaging for oral solids to over four billion tablets per year. In addition to the increase in its production capacity, Tjoapack says it will also be investing in its warehousing and cold-chain services. The company says the expansion will also see with the appointment of over 100 new employees.
This latest expansion follows Tjoapack’s recent investment announced in September (September 2020) into its automated packaging capabilities for pre-filled syringes and vials.
Vetter Continues Sustainability Strategy
Vetter, a CDMO of aseptic filling and packaging, has provided updates in its investments in climate protection.
Since the beginning of this year (2020), Vetter reports that all of its German company sites are carbon dioxide neutral, which continues the company’s use of and investment in green technologies The company’s recently completed headquarters in Ravensburg, Germany, known as Ravensburg Vetter Kammerbruehl, was built according to the latest environmental standards.
Additionally, at the company’s Center for Visual Inspection and Logistics called Ravensburg Vetter West, a sustainable energy concept specifically developed in-house was realized. This initiative includes the operation of an environmentally friendly block heating and power plant, the use of geothermal energy, the use of excess energy, and photovoltaic systems.
Most recently, Vetter opened corporate bicycle parking spaces at its production site, Ravensburg Vetter Sued. The new bicycle parking facilities are protected from the elements and contain more storage space than previously, as well as battery charging stations for e-bikes and tool sets for minor repair work. In the coming months (as reported on December 3, 2020), Vetter says additional company sites will be equipped with similar bicycle parking spaces.
Source: Vetter Pharma