CordenPharma, Seqens, Novasep, Samsung Biologics, Catalent ExpandBy
The latest from CDMOs, CMOs, and suppliers featuring CordenPharma, Seqens, Novasep, Catalent, Abzena, Samsung Biologics, MilliporeSigma, Lonza, Schott, Cytovance, and others.
Chemicals/Chemical API Manufacturing
CordenPharma To Expand Peptide Mfg Capacity
CordenPharma has announced plans to expand its solid-phase peptide synthesis manufacturing capacity at its Center of Excellence for Peptide Process Development and non-GMP manufacturing site in Frankfurt, Germany.
The company says along with increasing available lab space by 25%, a dedicated explosion-proof area will be added, which is supported by a tailored tank farm to allow for the introduction of regular solvents, as well as compatibility with the company’s green peptide manufacturing.
The expanded peptide manufacturing, explosion-proof area and tank farm will be available starting in the third quarter of 2021.
Seqens To Increase Production of Isopropanol with New Unit
Seqens is increasing production of isopropanol, a solvent used in the production of intermediates and active pharmaceutical ingredients, with a new unit in Isere, France. The new isopropanol unit will have a capacity of 45,000 tons for domestic production and is scheduled to come on stream early in 2022.
Novasep To Invest $7.7 M To Expand API Mfg
Novasep is investing EUR 6.5 million ($7.7 million) to expand capacity and increase flexibility in an active pharmaceutical ingredient (API) manufacturing workshop at its site in Chasse-sur-Rhône, France.
The revamping of this workshop and installation of two new synthesis reactors (4,000-L Hastelloy & 1,600-L glass-lined) is intended to increase plant flexibility and capacity for low- to medium-volume APIs. The project also involves repositioning a high-pressure hydrogenation reactor, currently located in the workshop, in a new dedicated area.
The company says construction of the utilities building is nearing completion, and the investment will be fully operational by the end of 2021.
Abzena Upgrades Facility for Phase III, Commercial Mfg
Abzena, a contract manufacturer of biologics and antibody drug conjugates, has upgraded its GMP chemistry suites in Bristol, Pennsylvania to allow Phase III and commercial manufacturing.
The facility upgrades includes two new GMP suites, one for small molecules, including high potency up to the 100-L scale, and one for conjugation, as well as other GMP facility upgrades.
Onyx Scientific Invests To Expand API Facility
Onyx Scientific, a CDMO of active pharmaceutical ingredients (APIs), has made an investment to expand its UK facility for a commercial API license.
As part of the initiative, Onyx will invest to implement quality-by-design and design-of-experiments principles into its API development and manufacturing practices. The company will also expand its team of scientists as well as its analytical and quality assurance teams.
Onyx has engaged with the Medicines and Healthcare products Regulatory Agency, the UK pharmaceutical regulatory agency, from the initial stages of its move to commercial manufacture. Following license approval, which is expected later this year (2020), its UK facility will have the capacity to manufacture low volumes of drug substance, particularly for orphan drugs. This new service will complement Onyx’s facilities in North Carolina and India, which offer larger-scale manufacturing.
Source: Onyx Scientific
Catalent Completes $14-M Acquisition of Cell-Therapy Mfg Company
Catalent has completed its acquisition of Skeletal Cell Therapy Support (SCTS), a cell-therapy manufacturing subsidiary of Bone Therapeutics, a Gosselies, Belgium-based cell-therapy company, for EUR 12 million ($14 million).
The acquisition includes the shares of SCTS, previously held by Bone Therapeutics, and SCTS’ cGxP facility of approximately 41,000 square-feet, which includes related quality control and product development laboratories, a warehouse, cleanrooms, and equipment as well as land for further development. As part of the acquisition, all of the manufacturing employees located in Gosselies and employed by SCTS will remain with SCTS and become part of Catalent.
With the acquisition, Catalent will undertake the manufacturing of clinical material for Bone Therapeutics’ Allob, an allogeneic osteoblastic cell-therapy product, derived from ex vivo cultured bone-marrow cells.
The facility is next to Catalent’s existing cell-therapy site and will allow Catalent to develop a European center of excellence in cell therapies. Catalent is continuing work on a dedicated 60,000-square-foot commercial-scale production and fill–finish facility in Gosselies, which is scheduled to be completed by the end of 2021. Catalent acquired the facility as part of its $315-million acquisition of MaSTherCell, a CDMO specializing in development and manufacturing services for cell therapies, in a deal completed earlier this year (February 2020). As part of the MaSTherCell acquisition, Catalent also gained a new 32,000-square-foot cell-therapy development facility in Houston, Texas, where validation is underway at the facility and is scheduled to be completed by the end of 2020.
Source: Catalent and Bone Therapeutics
Samsung Biologics Breaks Ground on New Bio-Mfg Facility
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has started construction of a new biopharmaceutical manufacturing facility in Incheon.
The new facility, Samsung Biologics’ fourth plant in Incheon, is expected to begin manufacturing activities by the end of 2022 with the goal to commence full operations in 2023.The new plant will have biomanufacturing capacity of 256,000 liters.
The new facility will have a line-up of bioreactors ranging from 2,000 liters, 10,000 liters, and 15,000 liters. The plant will provide early-stage development services and large-scale commercial manufacturing with a full quality control lab.
Source: Samsung Biologics
MilliporeSigma Expands Bioprocessing Software Suite
Millipore Sigma has launched the next component of its Bio4C Software Suite, the Bio4C Orchestrator Software.
The Bio4C Orchestrator Software connects individual unit operations to a centralized platform for monitoring of regulatory compliant biomanufacturing systems and processes. This browser-based software service provides remote access to systems, recipes, reports, user accounts, and alarms from a holistic process dashboard.
Cytovance Biologics Appoints New CEO
Cytovance Biologics, an Oklahoma City, Oklahoma-based biologics contract manufacturer, has named Bin Zhang as Chief Executive Officer (CEO).
Mr. Zhang served two months as Interim CEO before this formal appointment by the board to CEO. Mr. Zhang has been with Cytovance as a member of the Board of Directors since 2018. He will report to Mr. Li Li, founder and Chairman of the Board for Shenzhen Hepalink Pharmaceutical Group, a Shenzhen, Guangdong, China-based company that manufactures and distributes pharmaceutical products, and member of the Board of Cytovance.
Source: Cytovance Biologics
Formulation Development/Drug-Product Manufacturing
Lonza Expands Highly Potent Drug Product Development, Mfg Services
Lonza has announced additional investments in its oral drug-product development and manufacturing capabilities at its site in Tampa, Florida.
With these investments, services for formulation development have been expanded with the upgrade of drug-product development laboratories for highly potent material handling. Dry- granulation processing has been expanded and standardized with the addition of Gerteis roller compaction equipment. The new roller compactor will be equipped with high-containment features.
Lonza has invested more than $15 million to expand and upgrade the Tampa site over the last two years. The new roller-compaction equipment complements previously made for high-potency manufacturing, including a new sampling and dispensing suite, a dedicated suite for product development, and two new product-manufacturing suites.
Comar Breaks Ground at NJ Site
Comar, a specialty packaging, device and component supplier, has started construction on a new manufacturing facility in Vineland, New Jersey.
The new 159,000-square-foot Vineland location will house injection-molding machines, proprietary automation, and packaging equipment for medical, pharmaceutical, and consumer markets. Comar says it is actively recruiting to fill immediate openings for skilled technicians and shift operators for the plant.
The Vineland project is on track for substantial completion by March 2021 with production machinery installed shortly thereafter.
Ypsomed Forms Drug-Delivery Pacts with Lilly, Lonza, Schott
Ypsomed, a Burgdorf, Switzerland-based developer and manufacturer of injection and infusion systems, has entered into collaborations with Eli Lilly and Company for insulin-delivery systems and with Schott and Lonza for injectable drug-delivery systems.
Ypsomed entered a non-exclusive, global agreement to advance an automated insulin-delivery system as part of Lilly’s connected diabetes services. Under the agreement, Lilly will commercialize the system, which is currently in development, and which will include an insulin pump developed and manufactured by Ypsomed.
Lilly will commercialize a version of Ypsomed’s insulin pump, along with continuous glucose monitoring and automated insulin delivery technology, in the US and Europe. This pump will use pre-filled insulin cartridges for Lilly’s rapid-acting insulins.
Ypsomed says it plans to submit a version of its insulin pump for clearance to the US Food and Drug Administration for use in automated insulin delivery in 2022. If cleared, Lilly will have exclusive rights to commercialize the pump in the US,
Under a separate collaboration with Schott and Lonza, Ypsomed plans to integrate its patch injector as a single service. The YpsoDose patch injector platform is used for the subcutaneous self-administration of high volumes of liquid formulations.
The service will include a cartriQ glass cartridge from Schott as the primary packaging for the drug, the YpsoDose patch injector platform from Ypsomed, and the processes for filling, assembly, and testing of the final product by Lonza Drug Product Services.
Schott develops and supplies 10-mL cartriQ cartridges for the YpsoDose. These cartridges require fewer process steps during filling than conventional cartridges. Lonza Drug Product Services applies its knowledge in process development, testing and characterization and implements a filling and assembly process for YpsoDose at Lonza’s facilities in Stein, Switzerland.
Source: Eli Lilly and Company, Ypsomed (Lilly), Ypsomed (Lonza, Schott), Lonza, and Schott