CordenPharma, MilliporeSigma Expand; Vetter Moves Into New HQBy
The latest from CDMOs, CMOs, and suppliers featuring CordenPharma, MilliporeSigma, Vetter, Catalent, JSR Life Sciences, Incog BioPharma, Brand-Nu Laboratories and Cadlic.
Chemicals/Chemical API Manufacturing
CordenPharma Completes Highly Potent API Lab
CordenPharma has completed the addition of new highly potent active pharmaceutical ingredient (API) laboratory at its facility in Boulder, Colorado.
The new laboratory is capable of handling highly potent compounds with an occupational exposure limit as low as 1 ng/m3 and is available to customers. CordenPharma provides development and manufacturing services of highly potent APIs from clinical to commercial scale.
MilliporeSigma Launches New Viral Vector Mfg Platform
MilliporeSigma has expanded its viral vector manufacturing services with the launch of a new lentiviral production platform.
The VirusExpress Lentiviral Production Platform uses a suspension cell line rather than adherent-based production. In addition to accelerating process development, the company says the suspension culture format allows each batch of virus to be larger yielding, and the use of chemically defined medium eliminates concerns related to animal- and human-derived materials. The platform is available either through MilliporeSigma’s CDMO services for viral and gene-therapy products or by licensing for in-house production.
The new offering adds to MilliporeSigma’s investment in cell and gene therapies. In April 2020, the company announced a new $110-million, 140,000-square-foot commercial manufacturing center for viral and gene-therapy manufacturing at its facilities in Carlsbad, California. The facility, which is scheduled to open in 2021, doubles existing production capacity.
JSR Life Sciences Expands European Mfg Footprint
JSR Life Sciences, a Sunnyvale, California-based drug-development and manufacturing company, has invested in a newly expanded facility in Geneva, Switzerland that will co-locate primary European operations for its affiliate companies, KBI Biopharma, a Durham, North Carolina-headquartered biopharmaceutical CDMO, and Selexis, a Geneva-based provider of mammalian cell-line generation technology.
The two companies will occupy 8,700 square meters within Geneva’s ZIPLO (Industrial Zone Plan-les-Ouates). KBI Biopharma’s new 5,600-square-meter biologic bulk drug-substance manufacturing facility is scheduled to be operational by mid-2022 and will create more than 200 technical positions in development, operations, and quality assurance. The expansion includes two 2,000-L single-use manufacturing trains with process development and analytical testing labs on-site. Quality control testing for release and in-process testing will be performed on-site in the new Geneva facility while testing of drug-substance and drug-product stability will remain at KBI Biopharma’s laboratories in Leuven, Belgium.
Selexis’ Geneva footprint will increase by 200% and is scheduled to be operational by mid-2021. The new space will include laboratory, office, health/wellness, and employee common areas. In addition to new standard cell-line development suites, the new facility will also include two separate cell-culture suites to accommodate quarantined client-specific cell lines or client-dedicated cell-line spaces.
Source: JSR Life Sciences
Formulation Development/Drug-Product Manufacturing
New CDMO Incog BioPharma Investing $60 M for Injectables Mfg Facility
Incog BioPharma Services, a new CDMO of injectable drug products, is investing approximately $60 million to construct and equip its first manufacturing facility and global headquarters in Fishers, Indiana.
The company plans to break ground for the 60,000-square-foot facility as early as December 2020 with the target of being fully operational in the first half of 2022.
It plans to add more than 65 team members over the next two years and continue ramping up hiring as customer demand increases. Hiring will begin in early 2021 for positions in engineering, manufacturing sciences, quality assurance, human resources, project management, and business development. In all, the company plans to create up to 150 new jobs by the end of 2024.
The Indiana Economic Development Corporation (IEDC) offered Incog BioPharma Services up to $2.5 million in conditional tax credits based on its plans.
Source: Indiana Economic Development Corporation
Vetter Moves into New HQ in Germany; Updates Expansions
Vetter, a CDMO of aseptic filling and packaging, has moved into its new headquarters in Ravensburg, Germany, with the opening of a new building, known as Ravensburg Vetter Kammerbruehl.
Vetter invested roughly EUR 50 million ($59 million) in the new building, which is designed for around 1,000 employees. Its former headquarters, Ravensburg Vetter Verwaltung, was modified to be used as a training center to house the Vetter Academy, an education center for employees. In addition, a separate floor in the building is now used as an audit and conference location.
The company has made other recent investments. A new combination building for manual visual inspection and secondary packaging started operations at the Ravensburg Vetter Sued / Vetter Secondary Packaging site. A new cleanroom for the manufacturing of prefilled syringes is planned to be operational at its Schuetzenstrasse site in Ravensburg in 2021. At this location, Vetter also secured an adjoining plot of land for a further production building. The company also recently purchased a clinical manufacturing site in Rankweil, Austria, which is scheduled to be operational in the second half of 2021. In the coming years, Vetter says it also intends to further expand its quality control resources. Following the recent implementation of another machine for automated visual inspection, the company is planning to purchase three additional units for its Center for Visual Inspection and Logistics.
Catalent Launches Technology for Delayed-Release Softgels
Catalent has launched technology for the formulation and manufacture of delayed/enteric release softgel capsules.
The OptiGel DR technology allows softgel capsules to be formed by combining pectin, a naturally derived polysaccharide, with gelatin, to eliminate the need for a separate capsule- coating step.
Catalent’s site in St. Petersburg, Florida, is the first to offer the new OptiGel DR technology, with the service to be expanded in the future to its other softgel manufacturing facilities in Brazil, Canada, Germany, Italy, and Japan.
Caldic To Acquire Distributors Brand-Nu Laboratories and BNL Sciences
Caldic, a chemical distributor headquartered in Rotterdam, The Netherlands, has agreed to acquire two distributors of specialty chemicals for the biopharmaceutical/pharmaceutical industries: Brand-Nu Laboratories, headquartered in Meriden, Connecticut, and BNL Sciences, headquartered in Naas, Ireland.
Brand-Nu is a distributor of high-purity specialty chemicals, excipients, and biological raw materials. BNL Sciences is a distributor of raw materials to the pharmaceutical and medical device industries.
The transaction is expected to close prior to year-end and is subject to the satisfaction of customary closing conditions, including regulatory approvals.