Supplier News: CordenPharma, Lonza, Catalent & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring CordenPharma, Lonza, Catalent, MilliporeSigma, WuXi Biologics, Arranta Bio, and GenScript.
Chemicals/Chemical API Manufacturing
CordenPharma Invests in Flow Chemistry Center
CordenPharma has announced the completion of a Phase I investment to create a flow-chemistry center of excellence at its Chenôve facility near Dijon, France.
Phase I of the investment program was recently completed with the renovation of an R&D laboratory using flow-chemistry equipment and a newly hired team. Phase II of the investment has also been initiated, which includes the design and construction of a dedicated flow-chemistry pilot facility at CordenPharma Chenôve. The facility, which features a modular design concept, will have capacity to manufacture multiple 100-kg quantities and is expected to be completed by the end of 2021.
The company says future investments in this area are being considered to expand scale-up resources for increasing scales while designing custom-manufacturing skids and processes.
MilliporeSigma Expands ADC Capabilities
MilliporeSigma has launched new technology and expanded capacity for antibody-drug conjugates (ADC).
The company has launched its ChetoSensar technology to address the hydrophobicity of ADCs and its Dolcore platform for ADC payloads.
In addition, the company it adding to its ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri to provide a larger footprint to enable large-scale production, including chromatographic purification for early-phase clinical supply. This follows the company’s announcement last year (September 2020) of a $65-million expansion of its facility near Madison, Wisconsin, to double its high-potency active pharmaceutical ingredient (HPAPI) kilo lab capacity for the manufacture of HPAPIs, ADC linker/payloads, and complex APIs.
Lonza Expanding Mfg for Exosomes & Related Services
Lonza is expanding its exosomes manufacturing and service offering with the acquisition of a service unit from Exosomics, an extracellular vesicles biotech company, and the acquisition of an exosome manufacturing facility from Codiak BioSciences, a clinical-stage bio/pharmaceutical company developing exosome-based therapeutics.
The agreement with Exosomics includes its service team, service assets, and laboratories in Siena, Italy. The financial details of the deal were not disclosed. Lonza has been a minority shareholder of Exosomics since 2017 and will remain a shareholder after the acquisition of the service unit is complete.
Under the agreement, Lonza will gain access to expertise and capabilities in extracellular vesicle analytics and characterization. In addition to research and development, Lonza will expand the service offering from the site to a suite of development and analytical services for exosomes.
Separately, with the agreement with Codiak, Codiak will retain its pipeline of therapeutic candidates as well as its exosome-engineering and drug-loading technologies. Codiak will receive as part of the deal approximately $65 million of manufacturing services in kind. Lonza will gain global access and sub-licensable rights to Codiak’s perfusion-based process for exosome manufacturing.
Lonza and Codiak will establish a center of excellence for the development of exosome- manufacturing technologies. The center of excellence will advance developments in exosome production, purification, and analytics.
Arranta Bio To Sell Mfg Facility to Inceptor Bio
Arranta Bio, a CDMO focused on live biotherapeutic products and the human microbiome, has agreed to sell a process development and clinical manufacturing facility in Gainesville, Florida, to Inceptor Bio, a Raleigh, North Carolina-based bio/pharmaceutical company.
Inceptor will gain the 29,000-square-foot facility and a core operating team to establish cell-therapy processes and clinical supply for Inceptor Bio’s oncology therapy candidates.
Inceptor Bio currently has three cell-therapy technologies: a CAR-T platform with co-stimulatory technology, a CAR-M platform using macrophages with enhanced phagocytic capabilities, and a CAR-NK platform.
Source: Arranta Bio
GenScript Opens Mfg Facility
GenScript USA, a Piscataway, New Jersey-based research reagent provider, has opened a new facility for gene synthesis and plasmid preparation services. The new facility, located near the company’s US headquarters in Piscataway, is GenScript’s first automated manufacturing site in the US and represents a 10-fold increase in capacity.
Formulation Development/Drug-Product Manufacturing
WuXi Biologics Launches Drug-Product Mfg Facility
WuXi Biologics, a contract biologics manufacturer, has launched the GMP operation of its new drug-product facility in Wuxi, China, and a new drug-product packaging center.
The 12,000-m2 drug-product facility, called DP2, features an isolator filling line for continuous high-speed production with capacity of up to 60 million vials for commercial drug-production per year.
Additionally, WuXi Biologics has also launched the operation of a new drug-product packaging center, which includes the company’s first fully automated vial packaging line.
Source: WuXi Biologics
Catalent Opens New Clinical Supply Facility
Catalent has opened a new clinical supply facility in in San Diego, California. The 24,000-square-foot facility is located within a mile of the company’s early-phase oral drug-product center of excellence and has been established to support clinical studies in Phases I-III. The site offers end-to-end services, including supply management, primary and secondary packaging, and labeling, storage, distribution, returns, and destruction.