The latest from CDMOs, CMOs, and suppliers featuring National Resilience, Jubilant HollisterStier, Colorcon and Emergent BioSolutions.  

Biologics Manufacturing 
* Colorcon Ventures Invests in Vedanta Biosciences 
Formulation Development/Drug Product Manufacturing 
* Resilience Investing $225 M In Drug-Product Capacity Expansion
* Jubilant HollisterStier Opens Third Sterile Fill-Finish Mfg Line  
* Incog Biopharma Adds New Filling Line 
* Evonik, University of Mainz In Lipid Pact 
General 
* Emergent Bio Appoints New CEO 

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Biologics Manufacturing 

Colorcon Ventures Invests in Vedanta Biosciences 
Colorcon Ventures, the corporate venture fund of Colorcon, a manufacturer of excipients, has invested in Vedanta Biosciences, a clinical-stage bio/pharmaceutical company that designs and manufactures orally delivered bacterial therapies. 

Vedanta’s pipeline includes product candidates, VE303, currently being advanced into a Phase III registrational trial for treating recurrent C. difficile infection, and VE202, currently enrolling patients in a Phase II trial for treating inflammatory bowel disease.   

Source: Colorcon Ventures 

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Formulation Development/Drug Product Manufacturing 

Resilience Investing $225 M In Drug-Product Capacity Expansion 
National Resilience, a CDMO of biologics and advanced therapies, has announced the expansion of the company’s clinical and commercial drug-product manufacturing capabilities across its network.  

In Cincinnati, at least $225 million is planned to be invested to increase the site’s drug-product capacity. The site has three high-speed fill lines for vials, cartridges, and pre-filled syringes (PFS), with a fourth PFS fill line slated to be ready by 2025. The facility is also expanding to six device assembly and packaging suites by 2025. 

Additionally, Resilience is expanding its drug-product capabilities at the company’s  facility in Research Triangle Park, North Carolina, by using a modular design within its segregated expansion space to offer drug-product manufacturing for multiple modalities. The site has drug-substance and drug-product capabilities in support of gene-therapy medicines. It also has 45,000 square feet of grey space available for additional expansion for drug-product operations.  

Source: National Resilience 

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Jubilant HollisterStier Opens Third Sterile Fill-Finish Mfg Line 
Jubilant HollisterStier, a Spokane, Washington-based CDMO of sterile fill–finish injectables, ampules, ophthalmics, and sterile liquid products, has opened a third sterile fill–finish manufacturing line and broken ground on the next phase of its facility expansion. 

The expansion includes a new high-speed commercial fill–finish line, which is part of a 50,000-square-foot facility expansion, which increases the company’s production capacity by 55 million units per year. It also includes an additional three compounding suites with capacity for up to 2,000-L bulks and disposable, single-use compounding and filling technologies. The line is also outfitted with two new 300-square-foot lyophilizers. 

Source: Jubilant HollisterStier 

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Incog Biopharma Adds New Filling Line  
INCOG BioPharma Services, a Fisher, Indiana-based CDMO specializing in sterile injectables, is adding a high-speed filling line that will provide an additional 100 million units of syringe- and cartridge-filling capacity.  

This second filling line will be delivered on site this summer and qualified for GMP production in the second quarter of 2025. It will complement the company’s existing multi-use filling line, bringing the company’s total filling capacity to 140 million units per year. In addition to the new filling line, INCOG recently added automated visual-inspection capabilities and will soon complete qualification of equipment to support auto-injector device assembly services.  

In March of 2023, INCOG secured an additional $75 million of funding to initiate these expansion efforts.  

Source: INCOG BioPharma Services 

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Evonik, University of Mainz In Lipid Pact 
Evonik and the University of Mainz in Germany have signed a license agreement to commercialize randomized polyethylene glycols (rPEGs), a new class of PEGs.  

Polyethylene glycols (PEGs) are polymers used to improve the bioavailability, stability, targeting and performance of therapeutics. rPEG polymers have similar properties to PEGs but have a different structure that is intended to offer an improved immunogenicity profile. They are especially suitable for pharmaceutical applications, such as in lipids for lipid nanoparticle carriers. 

Evonik intends to use rPEGs for its platform of specialized lipids and commercialize the excipients under the license agreement. Technical grade rPEG-lipids will be available in the second half of 2024. 

Source: Evonik 

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General 

Emergent Bio Appoints New CEO 
The Board of Directors of Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, appointed Joseph C. Papa as President and CEO, effective February 21, 2024. Papa succeeds Haywood Miller, who stepped down from his role as interim CEO, effective February 21, 2024. 

Papa most recently served as CEO and Chairman at Bausch and Lomb Corporation, a global eye-health company. Prior to his role at Bausch and Lomb, Papa was the CEO and Chairman of Bausch Health. He previously served as the Chairman and CEO of Perrigo, a private-label over-the-counter pharmaceuticals manufacturer, and led the pharmaceutical and technologies services division at Cardinal Health, a healthcare services and distribution company. Before that, Papa held the role of President and Chief Operating Officer at Watson Pharmaceuticals and worked for 14 years at Novartis Pharmaceuticals in the US and Switzerland. 

Source: Emergent BioSolutions