Supplier News: MilliporeSigma, Abzena, Rovi, BSI & More
The latest from CDMOs, CMOs, and suppliers featuring MilliporeSigma, Abzena, Rovi, Ardena, PharmaLogic, Sterling Pharma Solutions, and BSI.
Chemicals/Chemical API Manufacturing
* MilliporeSigma Investing $76 M in ADC Mfg Facility Expansion
* Sterling Pharma Solutions Expanding ADC Mfg Facility
* PharmaLogic Opens New Radiopharmaceutical Mfg Facility
Biologics Manufacturing
* Abzena Expands Microbiology QC Lab
* BSI Expanding Production of Plant-Based Vaccine Adjuvant
Formulation Development/Drug Product Manufacturing
* Rovi Decides To Retain CDMO Business Following Strategic Review
General
* Ardena Adding New Bioanalytical Testing Lab
Chemicals/Chemical API Manufacturing
MilliporeSigma Investing $76 M in ADC Mfg Facility Expansion
MilliporeSigma, the life science business of Merck KGaA, has announced a $76-million expansion of its antibody drug conjugate (ADC) manufacturing capabilities and capacity at its Bioconjugation Center of Excellence in St. Louis, Missouri.
The investment will triple existing capacity and upgrade 34,000 square feet to support process and analytical development, quality control, research and development, manufacturing, and logistics. The expansion will add new labs, a dedicated manufacturing buffer preparation facility, and a cold-storage and a GMP-controlled room temperature warehouse that will be located close to the existing facility. The expansion will support early-stage and commercial bioconjugates.
The expansion is the latest by the company in ADC-based services. In 2022, the company opened a $65-million, 70,000-square foot facility in Verona, Wisconsin, to double the production of highly potent active pharmaceutical ingredients (HPAPIs) used in cancer therapies, including ADCs. In September 2024, the company launched the Mobius ADC Reactor, a scalable single-use mixer specifically designed for ADC manufacturing. The company also launched ChetoSensar, a technology that alleviates ADC solubility challenges as well as the ADCore portfolio of advanced payload intermediates.
Source: MilliporeSigma
Sterling Pharma Solutions Expanding ADC Mfg Facility
Sterling Pharma Solutions, a UK-based CDMO of small-molecule active pharmaceutical ingredients and chemistry services, has announced the second phase of an expansion plan at its Deeside, UK, site to support antibody-drug conjugate (ADC) development, with a more than £10 million ($13 million) investment to increase GMP bioconjugation capacity.
A new 2,300-square foot suite is being commissioned for clinical-scale manufacturing using reactors up to 500 liters in volume, which will more than double the site’s existing capacity.
The new suite will include a 1,400-square-foot Grade C cleanroom for ADC manufacturing, and will use both flexible and hard-containment technologies to handle highly potent molecules with exposure limits down to 0.01 micrograms per cubic meter (occupational exposure Band 5.) Existing ancillary GMP facilities at the site for buffer and reagent preparation, waste disposal, water-for-injection generation as well as analysis and quality control laboratories will support the new manufacturing suite. The site will also upgrade its stability chamber capacity for the storage and monitoring of final products. Completion of the project is expected in early 2026.
Source: Sterling Pharma Solutions
PharmaLogic Opens New Radiopharmaceutical Mfg Facility
PharmaLogic Holdings, a Boca Raton, Florida-based CDMO focused on radiopharmaceuticals, has opened a radiopharmaceutical production and research facility in Los Angeles, California. Acquired in 2022, the facility has undergone renovations and now holds new equipment for radiopharmaceutical manufacture.
Source: PharmaLogic
Biologics Manufacturing
Abzena Expands Microbiology QC Lab
Abzena, a San Diego, California-based CDMO of biologics and antibody drug conjugates, has announced an expansion of its quality control (QC) testing capabilities at its San Diego, California, biologics development and cGMP manufacturing site.
The new laboratory space adds to Abzena’s capabilities for antibodies with rapid microbiology release testing and offers improved scalability through advanced materials separation. The new lab was designed as a stand-alone space to separate product testing from all other testing being conducted in the microbiological space.
Source: Abzena
BSI Expanding Production of Plant-Based Vaccine Adjuvant
Botanical Solution Inc. (BSI), a producer of advanced botanical materials, is expanding GMP production of QS-21, a plant-derived adjuvant, used to stimulate the immune system in vaccines for shingles, respiratory syncytial virus (RSV), COVID-19, and malaria.
The company has added two dedicated laboratories in Davis, California, to conduct R&D activities focused on the optimization of a sustainable QS-21 production system. The traditional method of producing QS-21 is through harvesting mature Quillaja saponaria trees, native to Chile, and extracting the material from the bark. This method poses supply challenges due to its cost and the tree’s limited habitat in Chile and restrictions on deforestation. BSI has developed a proprietary in-lab cultivation, extraction, and purification process that allows for the growth of Quillaja saponaria trees within its own facilities and the use of plant tissue culture to produce QS-21.
BSI recently (August 2024) raised an additional $7 million to fund its expansion, bringing the total amount raised in Series A financing to date to $23 million.
Last year (2023), BSI partnered with Croda to supply the market with billions of QS-21 doses and enable the use of the adjuvant in vaccines for low-income countries.
Source: BSI
Formulation Development/Drug Product Manufacturing
Rovi Decides To Retain CDMO Business Following Strategic Review
Laboratorios Farmacéuticos Rovi, a Madrid-based pharmaceutical company and CDMO of drug products, reports that it will retain its CDMO business following a strategic review of its assets, including a potential sale of a stake in its CDMO business. The company reported that the process attracted offers from both investment funds and industrial companies who presented several proposals for its CDMO business, but following a evaluation of its assets, the company’s Board of Directors has decided to retain the CDMO business under the current group structure.
Source: Rovi
General
Ardena Adding New Bioanalytical Testing Lab
Ardena, a Ghent, Belgium-based CDMO of drug substances and drug products, has announced an expansion of its bioanalytical services in the Netherlands. The investment includes establishing a new bioanalytical lab at Ardena’s Pivot Park facility in Oss, the Netherlands, along with additional capacity and new GLP capabilities to its Bioanalytical Center of Excellence in Assen, the Netherlands.
The 3,000 square foot lab in Oss, expected to be operational by the first quarter of 2025, will provide advanced analytical testing services for both small and large molecules, employing LC-MS/MS and fluorometric detection assays, along with ELISA-based Gyrolab automated technology platform. In Assen, the focus is on expanding its capabilities in immunochemistry, flow cytometry, and qPCR platforms, increasing its LC-MS/MS capacity, and adding new Hamilton automated systems.
Source: Ardena
