Supplier News: CordenPharma, Catalent, Resilience & More
The latest from CDMOs, CMOs, and suppliers featuring CordenPharma, Wacker Chemie, National Resilience, Catalent, Pharmaron, Applied Pharmaceutical Innovation, and Berkshire Sterile.
Chemicals/Chemical API Manufacturing
* Canadian Gov’t Funding $59 M for Small-Molecule API Initiative
Biologics Manufacturing
* Resilience Approved for $410 M in US Gov’t Financing for Biomanufacturing
* Pharmaron Gets UK Gov’t Grant of $186 M for Cell- and Gene-Therapy Expansion
Formulation Development/Drug Product Manufacturing
* CordenPharma, Wacker Partner for AI-Based RNA Drug Development
* Catalent Launches Oral Developability Assessment & Mfg Solution
* Berkshire Sterile To Install 1,500 Solar Panels at Massachusetts Site
Chemicals/Chemical API Manufacturing
Canadian Gov’t Funding $59 M for Small-Molecule API Initiative
The government of Canada has provided CAD$80.5 million ($59 million) in funding to the Canadian Critical Drug Initiative (CCDI), a project designed to boost research, commercialization, and manufacturing in Alberta, Canada.
Led by Applied Pharmaceutical Innovation (API), an Alberta, Canada-based not-for-profit pharmaceuticals organization, in partnership with the Li Ka Shing Applied Virology Institute (LKSAVI) at the University of Alberta, the funding for the CCDI project will address two goals in drug development. First, it will produce drugs that are in short supply, and second, it will develop promising new drugs, particularly those being created at the LKSAVI. The funding will be used to build a new 40,000-plus square-foot manufacturing facility and upgrade a 72,000-square-foot Biotechnology Business Development Center. These facilities will produce small-molecule drugs and have a fill-finish line that will package and label the drugs for distribution.
Source: Applied Pharmaceutical Innovation
Biologics Manufacturing
Resilience Approved for $410 M in US Gov’t Financing for Biomanufacturing
National Resilience, a CDMO of biologics and advanced therapies, has signed a finance agreement for $410 million in long-term loan financing from the US Department of Defense, working with the US International Development Finance Corporation.
The loan financing will help Resilience establish domestic, end-to-end biomanufacturing capacity and capabilities for biologics (antibodies, proteins, multi-specifics), vaccines, and nucleic acids (including mRNA). Part of the financing will support the implementation of innovative manufacturing platforms and technologies that aim to reduce cost, strengthen the domestic supply chain, and increase the speed of vaccine supply.
Source: National Resilience
Pharmaron Gets UK Gov’t Grant of $186 M for Cell- and Gene-Therapy Expansion
Pharmaron Beijing, a Beijing-based provider of R&D services, has announced its Liverpool, UK- based gene therapy CDMO has received a £151-million ($186-million) grant from the UK government’s Life Sciences Innovation Manufacturing Fund to expand viral vector and DNA manufacturing facilities.
The expansion project, which involves more than 8,000 square meters, will provide a four-fold increase in gene-therapy process development and analytical capacity accommodating viral vectors, DNA, and RNA drug substances, and drug-product formulation. The expansion includes 3,500 square meters for future commercial-scale GMP capacity. Pharmaron acquired the facility from AbbVie in 2021.
Construction activities began in January 2023, and facility handover is expected in 2024.
Source: Pharmaron
Formulation Development/Drug Product Manufacturing
CordenPharma, Wacker Partner for AI-Based RNA Drug Development
CordenPharma and Wacker Chemie, a Munich, Germany-headquartered chemical company, together with Munich’s Ludwig Maximilian University (LMU) and the Humboldt University of Berlin (HU Berlin), have launched a project to accelerate the development of RNA-based drugs using artificial intelligence (AI)/machine learning.
The aim is to develop a new generation of lipid nanoparticles (LNPs), which are a component of RNA-based pharmaceuticals. Based on these formulations, a machine-learning algorithm is to be trained that automatically identifies the best constituents for new RNA formulations. The three-year project will start on April 1, 2023, and is receiving funding of approximately EUR 1.4 million ($1.5 million) from the German Federal Ministry for Economic Affairs and Energy.
The partners have different roles in the project. Wacker manufactures the RNA molecules and supplies the core component of RNA-based pharmaceuticals. Alongside messenger ribonucleic acid (mRNA), which is prioritized in clinical applications, Wacker is also producing other RNA molecules for the project, such as self-amplifying RNAs (saRNAs) and circular RNAs (circRNAs). The company is testing new manufacturing processes specifically for these.
Together with HU Berlin, CordenPharma will be developing building blocks for nanoparticles, so-called modified lipids. These ensure that actives safely enter the body and are released at their destination.
The data obtained from the physical, chemical, and biological analysis of the LNPs and the various RNA molecules will be used to train a machine-learning algorithm for RNA formulations.
Source: CordenPharma
Catalent Launches Oral Developability Assessment & Mfg Platform
Catalent has launched the ProteoSuite Oral suite, which allows the rational selection of orally developable targeted protein degrader (TPD) candidates and their advancement into clinical trials.
The platform uses custom TPD-specific assays and physiologically based pharmacokinetic and developability models. The service will identify orally developable drug candidates with the greatest chance of success. It will also give a development path to the clinic with consideration of the necessary advanced formulation technologies, such as lipid-based delivery and amorphous solid dispersions, as well as manufacturing, specialty handling, and integrated clinical supply capabilities to accommodate these highly potent molecules.
Source: Catalent
Berkshire Sterile To Install 1,500 Solar Panels at Massachusetts Site
Berkshire Sterile Manufacturing (BSM), a Massachusetts-based CDMO of sterile filling services, announced it plans to install solar panels by end of the second quarter in 2023 to offset 20% of the company’s energy consumption.
BSM’s 120,000-square-foot fill–finish and development site in Lee, Massachusetts, houses several cleanrooms, laboratories, office spaces, an onsite daycare center, and a warehouse. In the first quarte of 2023, the company installed a new roof with a new thermoplastic polyolefin membrane and improved insulation to reduce energy waste and prepare for the installation of nearly 1,500 solar panels, which are expected to produce around 500,000 kWh of electricity per year.
BSM expects the panels to be installed in June or July of 2023, largely on the facility’s south facing roof, where they will receive the most sunlight.
Source: Berkshire Sterile Manufacturing
