Supplier News: Resilience, CordenPharma, Curia & More
The latest from CDMOs, CMOs, and suppliers featuring National Resilience, Inc., CordenPharma, WuXi Biologics, Curia, LabVantage Solutions, and Yourway. Highlights below.
Biologics Manufacturing
* Resilience Raises $625 M To Expand Biomfg Network
* Curia, Replicate Bioscience in Pact for Self-Replicating RNA Platform
Formulation Development/Drug-Product Manufacturing
* CordenPharma Investing in Lipid Nanoparticle Development, Mfg
* WuXi Biologics Opens New Drug-Product Mfg Facility for Prefilled Syringes
Packaging
* Yourway To Build New European Depot in Ireland
General
* Curia Acquires Platform to Expand Antibody-Based Drug Discovery
* LabVantage Adds Mixed Reality Technology to LIMS Platform
Biologics Manufacturing
Resilience Raises $625 M To Expand BioMfg
National Resilience Inc., a CDMO of biologics and advanced therapies, has raised $625 million to expand its biomanufacturing network. The funding is in addition to a previously $600 million raised in August 2021. The company has raised $2 billion since its founding in 2020.
The company will use the funding to continue building its infrastructure network through collaborations, acquisitions, organic growth, and international expansion and by developing biomanufacturing technologies. Resilience is also investing in advanced R&D, including stable cell lines for viral vector production, distributed manufacturing for autologous cell therapy, and cell-free and continuous manufacturing for biologics.
Resilience, which focuses on five therapeutic modalities—biologics, vaccines, nucleic acids, and cell and gene therapies—currently has 10 facilities across North America, with more than one million square feet of manufacturing space and more than 1,600 employees. The company expects to add capacity and capabilities this year (2022) with projects underway at several existing sites.
Key recently completed projects or projects underway include: (1) the acquisition of bluebird bio’s manufacturing facility in Research Triangle, North Carolina; (2) the addition of capacity and capabilities, including drug-substance and drug-product manufacturing expansions coming on line in 2022 across sites in Alachua, Florida,, Boston, and Toronto, to support biologics and vaccines; (3) construction of a new facility in Marlborough, Massachusetts, to support vaccines and gene therapies, coming on line in 2023; and (4) the addition of a new cell- and gene- therapy process and analytical development and drug-substance manufacturing site in the Philadelphia region.
Separately, Resilience and The University of Texas MD Anderson Cancer Center have launched of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of cell therapies for patients with cancer. The Cell Therapy Manufacturing Center will be based in a 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage GMP manufacturing
Source: National Resilience (expansion), National Resilience (joint venture), and The University of Texas MD Anderson Cancer Center
Curia, Replicate Bioscience in Pact for Self-Replicating RNA Platform
Curia (formerly AMRI) and Replicate Bioscience, a San Diego, California-based company designing and delivering self-replicating RNA (srRNA) immunotherapies, have formed a collaboration for a development platform for Replicate’s srRNA therapeutics.
Curia’s process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale, which can be used in Phase I through clinical trials. Curia’s global mRNA development and manufacturing facility, located near Boston, Massachusetts, supports vaccine and other mRNA therapy development and manufacture through Phase II and III, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales.
Source: Curia
Formulation Development/Drug-Product Manufacturing
CordenPharma Investing in Lipid Nanoparticle Development, Mfg
CordenPharma is investing more than EUR 10 million ($10.7 million) in new lipid nanoparticle (LNP) formulation, development, and production areas and has increased its xRNA capabilities at its sterile injectable facility in Caponago, Italy. The expansion will support preclinical and clinical development of xRNA-based therapeutics (mRNA, siRNA, saRNA, microRNA, & similar).
The initial phase has started with CordenPharma expanding its R&D laboratory with LNP formulation development and analytical characterization capabilities at its CordenPharma Caponago sterile injectable facility.
CordenPharma’s Caponago operations are set for expansion from late 2022 into early 2023 with the construction of a new hub for LNP formulation with cGMP manufacturing, where clinical batches at any stage, including small commercial drug products that adopt LNP technology, will be made. The build-out will create up to 15 jobs, which CordenPharma plans to recruit and fill over the coming months (as reported on June 1, 2022).
Source: CordenPharma
WuXi Biologics Opens New Drug-Product Mfg Facility
WuXi Biologics, a contract biologics manufacturer, has launched a new drug product-manufacturing facility for pre-filled syringes in Wuxi, China.
The facility is the company’s ninth drug-product manufacturing facility for vials and prefilled syringes. The facility features an isolator filling line for continuous and steady filling services, which offers multiple volume delivery options for pre-filled syringes, including 1 mL long, 1 mL, 2.25 mL and 3 mL. The maximum filling speed can reach 400 PFS/min to support 17 million syringes of drug products manufacturing annually.
Source: WuXi Biologics
Packaging
Yourway To Build New European Depot in Ireland
Yourway, an Allentown, Pennsylvania-based courier and clinical packager, has announced construction of a new European depot in Dublin, Ireland.
The new facility is being built to support Yourway’s clinical trials offering, including courier services, primary and secondary packaging, and temperature-controlled storage from ambient room temperature (20°C) to liquid nitrogen (-180°C).
As the new flagship depot for the European continent, the Dublin site will be a global hub, supported by the company’s other European depots in London, UK; Kyiv, Ukraine; Minsk, Belarus; and Moscow, Russia.
The site is scheduled to be audit-ready by the fourth quarter of 2022 and will provide clinical, primary and secondary packaging, and courier services.
Source: Yourway
General
Curia Acquires Platform to Expand Antibody-Based Drug Discovery
Curia (formerly AMRI) has adopted the Beacon Optofluidic system and workflows from Berkeley Lights, an Emeryville, California-headquartered company developing platforms for biopharmaceutical processes, to accelerate and expand its antibody-based drug-discovery capabilities.
With the addition of the Beacon system, Curia is able to provide a portfolio of technologies and experience for progression of client antibody programs from the earliest stage of discovery, through maturation and development, to manufacture of drug substances and final drug products under GMP.
The Beacon system workflow at Curia uses its Pentamice platform, CHO-GSN and TunaCHO platforms, as well as the company’s antibody and cell-line engineering systems. The Pentamice platform, CHO-GSN and TunaCHO platforms, were developed at LakePharma, a San Carlos, California-based biologics contract research, development and manufacturing organization (CRDMO), which Curia acquired in 2021.
Source: Curia
LabVantage Adds Mixed Reality Technology to LIMS Platform
LabVantage Solutions, a provider of laboratory informatics products and services, including laboratory information management systems (LIMS), has signed an agreement with Holo4Labs (H4L), a Białystok, Poland-based IT company, to integrate H4L’s mixed reality software with the LabVantage’s LIMS platform to allow laboratories to digitize their lab processes via mixed reality. The agreement also includes ongoing development and integration of the two companies’ offerings and marks LabVantage’s commitment to commercial applications of the metaverse.
Source: LabVantage Solutions
