The latest from CDMOs, CMOs, and suppliers featuring Kindeva Drug Delivery, Eurofins CDMO Alphora, Upperton Pharma, KBI Biopharma/Argonaut, and Advanced Medicines Partners. 

Biologics Manufacturing 
* KBI Biopharma, Argonaut Form Strategic Alliance for End-to-End Mfg
* Advanced Medicines Partners Launched as New Gene-& Cell-Therapy CDMO 
Formulation Development/Drug Product Manufacturing 
* Kindeva Acquires Summit Biosciences  
* Eurofins CDMO Alphora Completes New Biomanufacturing Pilot Plant
* Upperton To Expand Sterile Fill–Finish With $6-M Investment 

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KBI Biopharma, Argonaut Form Strategic Alliance for End-to-End Mfg 
KBI Biopharma, a Durham, North Carolina-based biologics CDMO, and Argonaut Manufacturing Services, a Carlsbad, California-based CDMO of fill–finish and lyophilization services, have entered a strategic alliance to provide end-to-end drug-substance and drug-product manufacturing services. The arrangement provides an integration of drug-substance and drug-product manufacturing by combining KBI’s drug-development and biologics manufacturing services with Argonaut’s sterile fill–finish capabilities.  

Source: KBI Biopharma 

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Biologics Manufacturing

Advanced Medicines Partners Launched as New Cell- & Gene-Therapy CDMO 
Advanced Medicine Partners has launched as a new CDMO of advanced therapy products and analytical services, following its spin-off from Jaguar Gene Therapy, a Lake Forest, Illinois-headquartered gene-therapy company. Jaguar launched the CDMO with funding led by Deerfield Management Company, with additional investors, including ARCH Venture Partners, Nolan Capital, and others.  

Advanced Medicine Partners has more than 33,000 square feet of lab, office and warehouse space in Cary and Durham, North Carolina. The company is in the process of building out a 174,000-square-foot GMP manufacturing facility in Durham. 

The CDMO will continue to lead chemistry, manufacturing and controls (CMC) efforts for Jaguar Gene Therapy’s pipeline programs and will support CMC work for Deerfield’s academic projects and private portfolio companies. The company has also initiated work for several biotech and pharmaceutical clients. 

Source: Advanced Medicine Partners 

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Formulation Development/Drug Product Manufacturing 

Kindeva Acquires Summit Biosciences 
Kindeva Drug Delivery, a CDMO of drug-delivery services and autoinjectors, has acquired Summit Biosciences, an intranasal drug-delivery CDMO, from its founding family shareholders. 

The acquisition of Summit enhances Kindeva’s drug-delivery capabilities by adding a new drug-delivery platform and expands Kindeva’s portfolio of complex drug–device combination products (pulmonary, injectable, transdermal, and nasal).   

Summit’s 55,000-square-foot cGMP facility in Lexington, Kentucky, adds to Kindeva’s manufacturing footprint of nine development and manufacturing facilities across the US and UK. The facility is approved by the US Food and Drug Administration and European Medicines Agency. 

Source: Kindeva Drug Delivery  

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Eurofins CDMO Alphora Completes New Biomanufacturing Pilot Plant 
Eurofins CDMO Alphora, a Mississauga, Canada-based CDMO of active pharmaceutical ingredients, has completed construction of a pilot-scale biologics development facility.  

The 3,300-square-foot facility is dedicated to the development and scaling of monoclonal antibodies and other mammalian-based therapeutic proteins. The facility’s offerings include upstream and downstream development, process design, analytical development, GMP quality control testing, GMP cell-based assays, and scale-up capacity to 200 L for preclinical and Phase I supply. 

The facility can accommodate diverse batch sizes, both fed-batch and perfusion. The analytical laboratory offers a range of analytical testing and bio-assays for both GMP and non-GMP applications to support process and drug candidate characterization.  

Source: Eurofins CDMO Alphora 

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Upperton To Expand Sterile Fill-Finish With $6-M Investment 
Upperton Pharma Solutions, a Nottingham, UK-based CDMO of drug products, has announced a £5-million ($6.3-million) investment to expand operations into small-scale sterile fill–finish. 

After completing the build and qualification of a new 50,000-square-foot GMP facility during 2023, this new investment adds an additional 7,000-square-foot sterile manufacturing facility at the company’s Trent Gateway site in Nottingham, the UK. The facility will support the manufacturing of aseptic and terminally sterilized small-volume liquids for parenteral, ocular, and pulmonary delivery. 

The facility build is scheduled to begin in February 2024, with the facility commissioning and validation to be completed early in the fourth quarter of 2024. 

Source: Upperton Pharma Solutions