Supplier News: Lotte Biologics, Thermo Fisher, Vetter & More
The latest from CDMOs, CMOs, and suppliers featuring Lotte Biologics, Millipore Sigma, Thermo Fisher Scientific, Vetter, Kindeva Drug Delivery, Bionova, Eurofins CDMO Alphora, Formosa Labs, Cytiva, CordenPharma, Stevanato Group, SK pharmteco, Asahi Kasei Medical, ORI Biotech, Berkshire Sterile Manufacturing, Coriolis Pharma, and LabVantage Solutions.
Chemicals/Chemical API Manufacturing
* Formosa Labs Completes Acquisition of Synchem
Biologics Manufacturing
* Lotte Biologics, MilliporeSigma Sign Letter of Intent in Biomanufacturing & Process Development
* Thermo Fisher Opens New Ultra-Cold Facility for Advanced Therapies
* Bionova To Build Plasmid DNA Mfg Facility
* Cytiva Launches New CAR T Mfg Platorm
* SK pharmteco Launches Lentiviral Vector Analytical Services
* Asahi Kasei Medical Completes Assembly Plant for Virus Removal Filters
* ORI Biotech Launches Cell & Gene Therapy Mfg Platform
Formulation Development/Drug Product Manufacturing
* Vetter Announces Capacity Expansion in US and Germany
* Kindeva Expands Inhaler Mfg Facility for Green Propellant
* CordenPharma, Certest In Lipid Nanoparticle Pact
* Berkshire Sterile Manufacturing Appoints New President
* Eurofins CDMO Alphora Launches New Analytical Lab
* Coriolis Pharma Launches New US Unit & Preformulation mAb Platform
Packaging
* Stevanato Group Opens New Syringe and Cartridge Mfg Facility
General
* MilliporeSigma Opens Expanded Distribution Center in Germany
* LabVantage Acquires EHS Software Provider SEIN Infotech South Korea
Chemicals/Chemical API Manufacturing
Formosa Labs Completes Acquisition of Synchem
Formosa Laboratories, a Taiwan-based CDMO of active pharmaceutical ingredients (APIs), has successfully completed its acquisition of SynChem, a contract research laboratory located in suburban Chicago. SynChem will now operate under the new name SynChem-Formosa.
Source: Formosa Laboratories
Biologics Manufacturing
Lotte Biologics, MilliporeSigma Sign Letter of Intent in Biomanufacturing & Process Development
Lotte Biologics, a contract biologics manufacturer, and MilliporeSigma, the life sciences business of Merck KgaA, have signed a letter of intent (LOI) for a strategic partnership in biopharmaceutical manufacturing and process development.
Through this agreement, the two companies plan to cooperate on the following initiatives:
– Supply of essential raw materials for the development and production of biopharmaceuticals.
– Establishment of a reliable supply chain for raw materials.
– Supporting the development of the Lotte Biologics’ Bio Venture Initiative within its campus in Songdo, Incheon, South Korea.
Previously, Lotte Biologics had signed a memorandum of understanding with Millipore Sigma in 2022 for the expansion of Lotte Biologics; bio campus in Syracuse, New York, manufacturing services/products, and workforce training in the US. Following this, a business cooperation LOI was signed last year (2023).
Meanwhile, Lotte Biologics began construction of its Bio Plant 1 in Songdo, Incheon, South Korea last March, with the goal of obtaining GMP approval by the second half of 2026 and commencing operations in 2027.
Source: Lotte Biologics
Thermo Fisher Opens New Ultra-Cold Facility for Advanced Therapies
Thermo Fisher Scientific has opened a new clinical and commercial ultra-cold facility in Bleiswijk, the Netherlands. The new facility provides end-to-end support throughout the clinical supply chain for advanced therapies, including cell and gene therapies, biologics, antibodies and vaccines.
The facility builds on the company’s CDMO capabilities in bioservices and specialty logistics services, including biorepository solutions and critical material storage.
Source: Thermo Fisher Scientific
Bionova To Build Plasmid DNA Mfg Facility
Bionova Scientific, a CDMO of biologics, has announced plans to expand into plasmid DNA (pDNA) production with a new development and manufacturing facility in The Woodlands, Texas (near Houston).
When the new facility begins operation (planned for the first quarter of 2025), Bionova Scientific will offer pDNA development services and production of pDNA. GMP manufacturing is planned for later in 2025.
The expansion is part of a previously announced long-term strategic initiative by the company to broaden its services portfolio to cover a wider range of technical capabilities and therapeutic modalities.
Source: Bionova Scientific
Cytiva Launches New CAR T Mfg Platorm
Cytiva has announced a new Sefia cell-therapy manufacturing platform for the manufacture of CAR T therapies. The Sefia platform was developed as part of a collaboration with Kite, a Gilead company, in developing autologous CAR T cell therapies.
Source: Cytiva
SK pharmteco Launches Lentiviral Vector Analytical Services
SK pharmteco, a Rancho Cordova, California-based CDMO, has announced the upcoming launch of Lentiviral Vector (LVV) Analytical Services, a suite of analytical testing solutions specifically designed for LVV and cell-therapy programs.
Coinciding with the launch is the commissioning of a new, 20,000-square-foot cGMP testing facility, located on SK pharmteco’s King of Prussia, Pennsylvania, campus, with dedicated laboratory space specifically designed for replication-competent lentivirus testing and molecular-based analytics. The full platform is available for R&D testing now, with full cGMP testing capabilities slated for July 2024.
Source: SK pharmteco
Asahi Kasei Medical Completes Assembly Plant for Virus Removal Filters
Asahi Kasei Medical has completed the construction of its third assembly plant in Nobeoka, Miyazaki, Japan, for its Planova virus removal filters.
Planova cellulose hollow-fiber membrane filters, developed specifically for removing viruses from biotherapeutic products, were launched in 1989, followed by Planova BioEX hydrophilic PVDF hollow-fiber membrane filters in 2009. A line of cellulose hollow-fiber membrane filters, Planova S20N, was launched in 2022 featuring virus removal capability and simplified operation.
Source: Asahi Kasei
ORI Biotech Launches Cell & Gene Therapy Mfg Platform
Ori Biotech, a London-based manufacturing technology company, has announced the commercial launch of IRO, a platform supporting cell- and gene-therapy manufacturing
IRO supports early process development and the ability to scale into GMP manufacturing with the same instrument, consumables, and process.
Source: Ori Biotech
Formulation Development/Drug Product Manufacturing
Vetter Announces Capacity Expansion in US and Germany
Vetter, a Ravensburg, Germany-headquartered CDMO of aseptic filling and packaging, has announced plans to move and expand its development services site from Skokie, Illinois, to Des Plaines, Illinois, further investing in its US footprint.
The development plan involves a construction project at the Des Plaines site and the relocation and expansion of Vetter Development Services US from the Illinois Science and Technology Park over the next years. New buildings for clinical manufacturing and related services will be constructed. The move will effectively double the capacity of the company’s Development Services in the US and provide space for future expansion opportunities.
Simultaneously, the company plans additional major investments in its commercial business in the state of Saarland, Germany, to complement growth and capacity expansions in its sites in Ravensburg and Langenargen, Germany, which are currently underway.
The company has approved an additional commercial production site in Saarlouis, Saarland. The Saarland government plans to develop a technology park on the site in Saarlouis. The company has already started planning the phased development of a 125-acre site. The planned investment amounts to a value of several hundred million euros. Pharmaceutical production at the site is expected to start by 2030, and the company is planning to create up to 2,000 new local jobs in the years to come.
Source: Vetter
Kindeva Expands Inhaler Mfg Facility for Green Propellant
Kindeva Drug Delivery, a CDMO of drug-delivery services and autoinjectors, has announced the expansion of its Loughborough, UK, facilities for green propellant commercialization and a dedicated space for the company’s commercial analytical laboratory services team, who will be housed at this location after renovations are completed later this year (2024).
The expansion doubles Kindeva’s UK laboratory footprint, expands operations, and will relocate approximately 50 quality control employees from Kindeva’s Loughborough manufacturing site. The company recently announced an investment in a second manufacturing line for the production of pressurized metered-dose inhaler products containing low GWP (Global Warming Potential) propellants at this facility.
Source: Kindeva Drug Delivery
CordenPharma, Certest In Lipid Nanoparticle Pact
CordenPharma and Certest, a Zaragoza, Spain-based company focused on the development of new products with special emphasis in drug delivery with lipid nanoparticles (LNPs), and active pharmaceutical ingredient (API) synthesis, have signed a partnership agreement.
The partnership aims to add ionizable lipids to CordenPharma’s complex LNP formulation services and support bio/pharma companies’ development, discovery, and manufacturing of xRNA / xDNA from early clinical phase to commercial. The partnership complements CordenPharma’s recently announced strategy to address targeting with peptide-decorated LNPs and opportunities to enhance mRNA transfection with β-sitosterol.
Under the agreement, Certest will provide access to its ionizable lipids platform, supported by in vitro / in vivo and toxicology data. In the alliance, CordenPharma will provide its expertise in lipids development and manufacturing.
Source: CordenPharma
Berkshire Sterile Manufacturing Appoints New President
Berkshire Sterile Manufacturing, a CDMO of sterile manufacturing, has named James Hamilton, formerly Vice President of US Technical Operations at Ferring Pharmaceuticals, as the company’s new President. Current President Shawn Kinney is stepping down to retire, but he will remain on staff to provide support and guidance to the company.
Hamilton brings over 25 years of leadership experience in pharmaceutical manufacturing, quality, supply chain, engineering, and strategy. In addition to his leadership role at Ferring Pharmaceuticals, his background includes various roles of increasing responsibility at Forest Laboratories (later acquired by Allergan) and Renaissance Lakewood, a CDMO specializing in nasal sprays and sterile injectables.
Source: Berkshire Sterile Manufacturing
Eurofins CDMO Alphora Launches New Analytical Lab
Eurofins CDMO Alphora, a Mississauga, Canada-based CDMO of active pharmaceutical ingredients and drug products, has expanded its drug-product analytical services laboratory, increasing its footprint three-fold.
Located in Mississauga, Canada, the expanded facility marks the addition of specialized equipment and analytical techniques, tailored to offer analytical support for drug-product programs. The laboratory has expanded to encompass water activity measurements, intrinsic dissolution studies, additional glove box systems, an added suite of HPLCs, new stability chambers, and gas chromatography.
Source: Eurofins CDMO Alphora
Coriolis Pharma Launches New US Unit & Preformulation mAb Platform
Coriolis Pharma, a Munich, Germany-based CDMO of drug products, has announced the launch of a US-based commercial organization, which consists of business development and client project management professionals, and the launch of two platform services for developability assessment and pre-formulation screening of antibody drug candidates.
Source: Coriolis Pharma
Packaging
Stevanato Group Opens New Syringe and Cartridge Mfg Facility
Stevanato Group, a provider of drug-containment, drug-delivery and diagnostic products and services, has announced the inauguration of its Cisterna di Latina, Italy, plant for syringe and cartridge manufacturing.
The new site covers an area of 65,000 square meters and employs around 200 people. The facility started commercial production in the third quarter of 2023 and houses production lines developed by Stevanato Group for the production of its EZ-fill pre-sterilized syringes. Furthermore, the company is planning to implement production with EZ-fill pre-sterilized cartridges between 2025 and 2026 as the site becomes fully operational.
Source: Stevanato Group
General
MilliporeSigma Opens Expanded Distribution Center in Germany
MilliporeSigma, the life-sciences business of Merck KGaA, has opened a newly expanded distribution center in Schnelldorf, Germany. The investment of EUR 180 million ($196 million) added 25,000 square meters to the site, almost doubling its size. It now includes a new manual down-filling operation and additional space for the distribution of a wide range of products to laboratories and research facilities globally. The site employs 470 engineers, manufacturing, and distribution personnel.
The expansion of the Schnelldorf facility is part of a multi-year investment program. Since 2020, the company has announced industrial capacity and capabilities expansion projects in life sciences throughout Europe, China, and the US, of more than EUR 2 billion ($2.2 billion).
Source: MilliporeSigma
LabVantage Acquires EHS Software Provider SEIN Infotech South Korea
LabVantage Solutions, a provider of of laboratory informatics products and services, has acquired SEIN Infotech South Korea, a software provider of environmental, health, and safety (EHS) management applications.
This acquisition expands LabVantage’s capabilities in the Asia-Pacific region and enhances its environmental compliance offerings and enables the company to provide an integrated informatics platform with EHS management solutions for the global energy and chemical industries.
Source: LabVantage Solutions
