Supplier News: Veranova, Hovione, PCI Pharma & More
The latest from CDMOs, CMOs, and suppliers featuring Veranova, Hovione, Wacker, CordenPharma, PCI Pharma, Evotec and ProBio
Chemicals/Chemical API Manufacturing
* Veranova Investing $30 M To Expand ADC & Highly Potent API Mfg
Biologics Manufacturing
* ProBio Opens New Plasmid DNA & Viral Vector Facility
* US Gov’t, Evotec in mAb Supply Pact
Formulation Development/Drug Product Manufacturing
* Hovione Opens Continuous Tableting Line
Packaging
* PCI Pharma To Build New Packaging Facility in Ireland
General
* Wacker, CordenPharma Partner for Pandemic Readiness in Supply Pact with German Gov’t
Chemicals/Chemical API Manufacturing
Veranova Investing $30 M To Expand ADC & Highly Potent API Mfg
Veranova (formerly known as Johnson Matthey Health, the fine chemicals business of Johnson Matthey) has initiated a $30-million expansion of its antibody-drug conjugate (ADC) and highly potent compound development and manufacturing capabilities at its Devens, Massachusetts, facility.
The expansion will include a new high potent process development laboratory and two new cGMP suites designed to handle potent compounds with occupational exposure limits of less than 0.01 µg/m³. These facilities, equipped to manage high-potency compounds, ADC linker-payloads, and other complex molecules, will feature dedicated air-handling systems, airlocks for clean-in-place operations, isolator technology, and a range of processing capabilities, including synthesis reactors, chromatography, thin-film evaporators, and lyophilization.
Source: Veranova
Biologics Manufacturing
ProBio Opens New Plasmid DNA & Viral Vector Facility
ProBio, a Hopewell, New Jersey-based CDMO, has announced the expansion of its plasmid DNA and viral vector manufacturing capabilities with the opening of a new facility in Hopewell, New Jersey.
The facility spans approximately 128,000 square feet and encompasses office, laboratory, and manufacturing spaces outfitted with equipment and technology for process development and cGMP production of plasmid DNA and viral vectors, including adeno-associated virus, lentivirus, and retrovirus. The site supports tech transfer, method and analytical development, process development, drug-substance, drug-product manufacturing for both clinical and commercial-grade plasmid DNA and viral vector-based therapies.
Source: ProBio
US Gov’t, Evotec in mAb Supply Pact
Evotec, a Hamburg, Germany-based contract provider of drug discovery, development, and manufacturing services, has announced that its Seattle-based subsidiary, Just–Evotec Biologics, was selected by the US Department of Defense (DOD) to develop monoclonal antibody (mAb) development and manufacturing for the DOD’s Manufacturing Optimization Program. The multi-year program award, valued up to $39 million, will support the US government’s efforts to enhance its rapid-response capabilities for biologics medical countermeasures (MCM).
Under the program, Just–Evotec Biologics will focus on project activities and technologies to decrease the time for development, manufacturing, and chemistry, manufacturing and controls (CMC)-focused regulatory efforts. Activities include developing and testing process development optimization, improving efficiencies in cGMP manufacturing and drug-product release, and enhancing operational and resource workflows. The program will culminate in testing the optimized system components through rapid-response exercises, starting with a DOD-identified MCM antibody sequence, and ending with the manufacturing of clinical doses.
Source: Evotec
Formulation Development/Drug Product Manufacturing
Hovione Opens Continuous Tableting Line
Hovione, a CDMO of drug substances and drug products, has opened a continuous tableting line at its R&D Center in Lisbon, Portugal. The new line is the result of the partnership with GEA Pharmaceutical Solutions, a bio/pharmaceutical equipment and process development technology provider, which was formed in 2022, to advance continuous tableting technology and use. The line also can handle highly potent active pharmaceutical ingredients.
Source: Hovione
Packaging
PCI Pharma To Build New Packaging Facility in Ireland
PCI Pharma Services, a Philadelphia, Pennsylvania-based CDMO of drug products and contract packager, has signed a 25-year lease agreement with the Irish government and will construct a new industrial facility in Stamullen, County Meath, Ireland. The facility will provide 82,000 square feet of additional production and services space alongside the company’s existing 45,000-square-foot facility. The building is slated to be completed in the first quarter of 2025, with PCI then undertaking an extensive fit-out for commercial pharmaceutical packaging operations.
Source: IDA Ireland
General
Wacker, CordenPharma Partner for Pandemic Readiness in Supply Pact with German Gov’t
Wacker Biotech, a CDMO of biologics and a subsidiary of Wacker Chemie AG, and CordenPharma, a CDMO of drug substances and drug products, have announced that their previously formed joint consortium has officially entered the pandemic readiness state as of June 2024. Following a successful expansion and qualification phase, the companies are now in stand-by phase for at least five years.
Given the initial vaccine shortage during the coronavirus pandemic, the German government made the decision to secure the production and supply of vaccines for the future, and as a result, companies were able to apply for pandemic-preparedness contracts with the German government. As joint bidders for the production readiness of mRNA-based vaccines, Wacker and CordenPharma were among those companies awarded a contract.
In the event of a new pandemic, Wacker and CordenPharma have taken the necessary steps to produce 80 million vaccine doses a year within a short time. The two companies will receive a fee to keep their production capacity and expertise available in a stand-by phase for at least five years. Should the need arise, the German government will contact the developer of the specific mRNA vaccine that is required. Wacker and CordenPharma will then jointly produce this mRNA vaccine, with most of the production steps taking place in Germany, and every production step occurring within the European Union.
In its site in Halle, Germany, Wacker will produce plasmid DNA (pDNA), which is a starting material for the manufacture of mRNA. The mRNA active based on pDNA will also be produced there, along with the formulation using lipid nanoprticles (LNPs) of the mRNA active. In preparation, Wacker expanded its site over the last two years, culminating in the recent announcement of its new mRNA Competence Center in Halle, Germany.
As part of the consortium, CordenPharma is ready to manufacture custom and standard lipids in its Frankfurt, Germany, and Chenôve, France, sites, as well as provide aseptic fill–finish and packaging of the chosen mRNA-based vaccine at its Caponago, Italy, facility. During the two-year qualification phase, CordenPharma successfully invested in multiple expansions, including new lipid purification capacity and capabilities utilizing supercritical fluid chromatography, and new compounding and freezing equipment. For pandemic readiness, Wacker and CordenPharma have further strengthened their production security and supplier network, as part of a complex pandemic-readiness strategy across the EU sites involved.
Source: CordenPharma and Wacker
