Supplier News: Piramal Pharma, Wacker Biotech, Jubilant Hollister & More
The latest from CDMOs, CMOs, and suppliers featuring Piramal Pharma, Wacker Biotech, Jubilant Hollister, KBI Biopharma, Selexis, Cytiva, W.R. Grace, Croda, Microsize, Solvias, Cergentis, Sharp, and Intravacc. Highlights below.
Chemicals/Chemical API Manufacturing
* Piramal Pharma Opens Canadian API Plant
* W.R. Grace Expanding Small-Molecule API Production
* Wacker Biotech Investing $101-M for mRNA Mfg
* KBI Biopharma, Selexis Open Joint Biologics Facility
* Cytiva Acquires US Resin Mfg Facility
* Solvias Acquires Cergentis for Biologics Testing
* Intravacc Gets EU Funding for ALS Vaccine
Formulation Development/Drug Product Manufacturing
* Jubilant HollisterStier Investing $77 M to Expand Drug-Product Mfg Facility
* Croda, US Gov’t Partner for New Lipid Mfg Facility
* Lonza’s Former North American Micronization Biz Launches as Microsize
* Sharp Expands Secondary Clinical Packaging
Chemicals/Chemical API Manufacturing
Piramal Pharma Opens Canadian API Plant
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has opened a new API plant at the company’s site in Aurora, Ontario, Canada.
The new plant, part of a CAD$30 million (US$23 million) investment in the Aurora site, has 10,000 square feet of manufacturing space and includes two reactor suites with additional filtration and drying capabilities. It expands the company’s ability to produce clinical to commercial scale APIs, including highly potent APIs requiring an occupational exposure limit of 1 mcg/m3.
Source: Piramal Pharma Solutions
W.R. Grace Expanding Small-Molecule API Production
W. R. Grace, a specialty chemical company, is expanding its contract development and manufacturing facility in South Haven, Michigan, to support small-molecule active pharmaceutical ingredient production.
The expansion includes a new 4,000-gallon multi-use reactor train consisting of glass-lined and stainless-steel materials of construction and a Hastelloy centrifuge to facilitate product isolation. The expansion is slated for completion in January 2024.
Source: W.R. Grace
Wacker Biotech Investing $101-M for mRNA Mfg
Wacker Biotech, a biologics CDMO and part of the chemicals company, Wacker, is investing EUR 100 million ($101 million) to expand its site in Halle, Germany, to add a mRNA competence center.
Four new production lines are to be built, which, among other things, will produce mRNA vaccines. Part of the new capacity will be available to the German federal government as part of the company’s pandemic preparedness contracts.
The expansion, which would triple production capacity at the Halle site, includes a new building with four floors, which is to be connected to an existing building. Alongside the four mRNA production lines, the new building will contain storage areas, quality control laboratories, office space, and recreation rooms. Wacker says it intends to hire around 200 new employees as part of the expansion. Recruitments are being sought in all departments, particularly laboratory assistants and pharmaceutical technicians, as well as employees in production, supply-chain management, and quality control, who will be trained in the coming months (as reported on July 5, 2022) to be ready for the start of production in 2024.
Source: Wacker Biotech
KBI Biopharma, Selexis Open Joint Biologics Facility
KBI Biopharma, a Durham, North Carolina-based biologics CDMO, and Selexis, a Plan-les-Ouates, Switzerland-based provider of cell-line development services, have opened a joint 94,000-square-foot facility in Geneva, Switzerland, for cell-line development and biologics CDMO services. Both companies are part of JSR Life Sciences, a Sunnyvale, California-based provider of drug-discovery and development services and products for biopharmaceuticals.
The facility will house new laboratories to support cell line workflows, process development, cGMP manufacturing, and quality control with a suite of analytical testing laboratories and cGMP single-use manufacturing trains. The expansion will generate over 300 positions in development, operations, and quality assurance.
Source: KBI Biopharma
Cytiva Acquires US Resin Mfg Facility
As part of a previously announced $1.5-billion expansion plan of Cytiva and Pall, both part of Dahaner Corporation, Cytiva has acquired a chromatography resin manufacturing facility in Muskegon, Michigan. The facility is the first resin manufacturing facility for Cytiva outside of Sweden.
Cytiva plans to transform the site into a 168,000-square-foot biomanufacturing center consisting of multiple buildings, which will house approximately 200 employees when completed. Cytiva plans to start construction in the third quarter of 2022, with manufacturing expected to begin in 2026.
Solvias Acquires Cergentis for Biologics Testing
Solvias, a Kaiseraugst, Switzerland-based contract research, development and manufacturing company, has acquired Cergentis, an Utrecht, the Netherlands, genomics-focused biotechnology company to bolster its biologics and cell- and gene-therapy testing capabilities.
Intravacc Gets EU Funding for ALS Vaccine
The European Union has awarded EUR 2.5 million ($2.5 million) to Intravacc, a Bilthoven, the Netherlands-based CDMO of vaccines against infectious diseases, and the German Center for Neurogenerative Diseases (DZNE), a research institute funded by the German federal and state governments, to develop a prototype vaccine for amyotrophic lateral sclerosis (ALS), including process development, scale-up, and toxicology studies. The project aims to develop the vaccine candidate identified at DZNE to the point where it can be clinically tested in humans.
Formulation Development/Drug Product Manufacturing
Jubilant HollisterStier Investing $77 M to Expand Drug-Product Mfg Facility
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 government of Quebec is providing a loan of CAD$25 million (US$19 million), which includes a forgivable portion of CAD$6.3 million (US$4.8 million) to fund the capacity expansion. The loan disbursement is subject to final agreement to be signed by both parties.
Source: Jubilant HollisterStier
Croda, US Gov’t Partner for New Lipid Mfg Facility
Croda, an excipient manufacturer, has entered into a cooperative agreement with the US government under which the government will provide up to $75 million to support the expansion of the company’s US manufacturing capacity of ingredients for lipid systems, which are used in drugs and vaccines, including mRNA vaccines.
Croda will also invest up to $58 million to bring the total project investment to up to $133 million, which will be used to establish a new lipid facility as part of a new multi-purpose cGMP site in Lamar, Pennsylvania. Construction is expected to start later this year (2022) with the new capacity anticipated in 2025. The facility will be the company’s third lipid manufacturing facility; the company also has facilities in Alabaster, Alabama, and Leek, UK.
Lonza’s Former North American Micronization Biz Launches as Microsize
Microsize, the former North American micronization business of Lonza, has launched as an independent stand-alone company following the completion of the sale of the business to a group of investors consisting of former industry executives.
Microsize is based in Quakertown, Pennsylvania, and consists of three facilities with over 100,000 square feet of space, including a R&D center, analytical development, GMP manufacturing suites, and GMP warehousing. The business was originally Powdersize, which Capsugel acquired in 2016, and Lonza subsequently acquired Capsugel in 2017.
Microsize is headed by Derek Hennecke, Chairman, who most recently was CEO of Xcelience, a Tampa, Florida-based CDMO of drug products, which Capsugel also acquired in 2016, and Lonza subsequently acquired Capsugel in 2017. TJ Higley is leading Microsize as its CEO and was a previous owner of Powdersize.
Sharp Expands Secondary Clinical Packaging
Sharp, a provider of contract packaging and clinical supply services, has added labelling and secondary packaging for clinical trials to its existing clinical storage and distribution capabilities at its facility in Heerenveen, the Netherlands.
Sharp can now deliver a full suite of clinical services from the facility including, secondary packaging under 15-25°C, 2-8°C and on dry ice, storage and distribution up to and including 80°C as well as Qualified Person release for clinical trial materials.