Supplier News: Fujifilm, Catalent, CoreRx, Almac & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Fujifilm, Catalent, CoreRx, Almac, Stevanato, Yapan Bio, Exothera, Berkshire Sterile, and Purolite.
* Fujifilm Establishes Bio-CDMO site in Toyama, Japan
* Catalent Investing $12 M to Add Biologics Analytical Labs
* Yapan Bio Opens Biologics Process Development Facility
* Almac Adds Cryogenic Capabilities for Advanced Therapies
* Exothera Gets OK for Belgium Viral Vector Mfg Facility Expansion
* Purolite Completes Bioprocessing Resin Expansion
Formulation Development/Drug Product Manufacturing
* CoreRx Launching Dedicated Particle-Engineering Biz, Bend Bioscience
* Berkshire Sterile Launches Small-Volume Filling
* Stevanato, IL Group Partner To Integrate Visual Inspection & Labeling
Fujifilm Establishes Bio-CDMO site in Toyama, Japan
Fujifilm Corporation has announced that it will establish a Japanese bio-CDMO site in Toyama City, Toyama Prefecture, Japan. The new site will be able to provide end-to-end services from drug substance production through to fill–finish and final packing. It will be operated by Fujifilm’s subsidiary, Fujifilm Toyama Chemicals, and will be operational in 2026.
The new site is in response to the Japanese government’s goal of having dual-use facilities in Japan that can supply biopharmaceuticals in normal times but be available for domestic vaccine manufacturing for future pandemics. Fujfilm already has a biologics CDMO business, Fujifilm Diosynth Biotechnologies, which has facilities in the US and Europe, and the new facility will be its first CDMO site in Japan.
Source: Fujifilm Corporation
Catalent Investing $12 M to Add Biologics Analytical Labs
Catalent is investing $12 million to increase biologics cGMP analytical capabilities at its facility in Kansas City, Missouri. The project will see the addition of two new analytical development laboratories to support of assay development for both traditional biologic and advanced biologic modality programs.
The first of the two new laboratories will cover approximately 3,500 square feet and will be completed by the end of October 2022, with the second, measuring 3,000-square feet, due to be operational in the first quarter of 2023. The expansion will create approximately 50 new scientific positions.
Catalent’s Kansas City facility is a center of excellence for its standalone biologics analytical services business and provides cell-based assays and characterization studies for drug substance, drug products, and intermediates. It also provides a range of services for oral solid dosage forms as well as clinical packaging and supply services. In April 2022, Catalent announced the completion of an expansion project to increase capacity and capabilities for producing encapsulated oral solid dose forms at the site.
Yapan Bio Opens Biologics Process Development Facility
Yapan Bio, a Hyderabad, India-based biologics CDMO has opened a new biologics process development facility at its site in Genome Valley, Hyderabad, India.
With the expansion, Yapan has enhanced its ability to support end-to-end development and manufacturing of RNA, DNA, and gene-therapy products starting from plasmids. The expansion includes three upstream suites (with Bio-Safety Level-2 containment), a downstream process development lab, an analytical development lab, and supporting infrastructure. The new labs will support manufacturing of clinical trial materials.
Piramal Pharma Ltd., the parent company of Piramal Pharma Solutions, a CDMO of small-molecule active pharmaceutical ingredients and drug products, holds a minority equity stake in Yapan Bio.
Source: Piramal Pharma Ltd.
Almac Adds Cryogenic Suite for Advanced Therapies
Almac Clinical Services, part of the Almac Group, a Craigavon, UK-based CDMO of active pharmaceutical ingredients and drug products, has added a GMP cryogenic suite for cell and gene therapies at its site in Durham, North Carolina.
The suite features processing rooms to safely handle, package, and label therapies under cryogenic conditions with segregated processing rooms with cryogenic freezers, capable of storing 40,000+ vials in -150 °C to -196 °C temperature ranges. The suite is in addition to the company’s overall $4-million investment cold-chain technology at its site in North Carolina.
Source: Almac Group
Exothera Gets GMP Certificate for Belgium Viral Vector Mfg Facility
Exothera, a Brussels, Belgium-based CDMO of viral vectors for vaccines, cell therapies, and gene therapies, reports that Belgium’s Federal Agency for Medicines and Health Products has granted a GMP certification for its facilities in Jumet, Belgium. The facilities are on the campus of Univercells, a provider of biomanufacturing technologies, and parent company of Exothera.
Exothera was founded in 2020. Initial operations began at two sites in Nivelles and Gosselies, Belgium, while renovation and construction of new offices and large process development and production areas took place in two buildings on the Univercells campus in Jumet. These facilities now provide a combined area of 8,600 square meters, with a recent expansion adding a GMP manufacturing area totaling 2,100 square meters. The facility includes five upstream Grade C cleanrooms with several bioreactor technologies for adherent and suspension cell culture. The bioreactors can go up to 2 x 2,000 L for the suspension platform and 2 x 600 square meters for the adherence platform.
Purolite Completes Bioprocessing Resin Expansion
Purolite, a King of Prussia, Pennsylvania-based supplier of life-science products has completed an expansion of its facility in Wales, UK to bioprocessing resin production. The expansion triples the company’s production capacity. The company also opened a new Customer Experience Center, which features hands-on interactive and educational displays to showcase Purolite’s expanded bioprocessing capabilities.
The new center is running in parallel to expansions at Purolite’s US facility in King of Prussia, Pennsylvania, as well as advancements to the company’s manufacturing plants in China and Romania. Purolite’s King of Prussia facility is currently gearing up for agarose resin production.
Formulation Development/Drug Product Manufacturing
CoreRx Launching Dedicated Particle-Engineering Biz, Bend Bioscience
CoreRx a Clearwater, Florida-based CDMO of drug products, is launching a new dedicated business for particle-engineering technologies, Bend Bioscience. The new company, based in Bend, Oregon, will focus on drug- delivery R&D partnerships, product development, and early-phase manufacturing for formulations using particle-engineering-based drug-delivery technologies. The business is being established by funding from QHP Capital, the management company for NovaQuest Private Equity, a healthcare and life-sciences focused private-equity firm.
Areas of focus for Bend Bioscience will include bioavailability enhancement, solid dosage form development, stabilization of biologics and vaccines, and particle engineering for pulmonary delivery. Its operations will include approximately 20,000 square feet of laboratory, processing suites, and office space for 50 employees. Bend Bioscience is expected to begin operations in its R&D and innovation lab in December (December 2022), with additional manufacturing and analytical capabilities slated to be operational in mid-2023.
Berkshire Sterile Launches Small Volume Filling
Berkshire Sterile Manufacturing, a Lee, Massachusetts-based CDMO of injectable drugs, has launched a small-volume sterile filling process. Batches up to 1.1 L of drug product can be processed During fill studies, individual fill volumes remained within 1% of the set dispense volume down to fill volumes of 75 micrograms.
Source: Berkshire Sterile
Stevanato, IL Group Partner To Integrate Visual Inspection & Labeling
Stevanato Group, a Padua, Italy-based provider of drug-containment, drug-delivery and diagnostic products and services, has formed a collaboration with IL Group, a Ichinomiya-shi, Japan-based producer of pharmaceutical labels and labeling machines, to provide an integrated and automated system for visual inspection and labeling to improve and facilitate the handling and storage of sensitive drugs.
Stevanato’s s vision robot unit (VRU) coupled with the IL Group’s model labeling technology will allow automatic inspection of cosmetic and particle defects in hazardous and sensitive drugs and their glass containers without human intervention.
In addition to the integration of visual inspection and labeling machines, the companies will provide drug containment and vial protection that includes Stevanato’s SG EZ-fill vial platform, and the Vial Protect Pack by IL Group, a shrink tack label to the vials, which minimizes the risk of breaking and shattering and prevents the content from spilling.
Source: Stevanato Group