A roundup of manufacturing news from Amphastar Pharmaceuticals, Ultragenyx Pharmaceutical, Cellular Origins, Catapult and Resolution Therapeutics. Highlights below. 

* Amphastar To Expand US Mfg Capacity  
* Ultragenyx Receives FDA Complete Response Letter for Rare Disease Drug over Mfg issues    
* Cellular Origins, Catapult, Resolution Therapeutics Form Industry Consortium for Automated Cell-Therapy Mfg 

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Amphastar To Expand US Mfg Capacity 
Amphastar Pharmaceuticals, a Rancho Cucamonga, California-based bio/pharmaceutical company developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products,has announced a multi-year expansion of its US manufacturing operations at its headquarters in Rancho Cucamonga, California.  

The company plans to quadruple its production capacity at this location over the next three to five years. It will feature a new production plant, expanded automation, and the integration of advanced technologies. 

Source: Amphastar Pharmaceuticals 

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Ultragenyx Receives FDA Complete Response Letter for Rare Disease Drug over MFG issues   
Ultragenyx Pharmaceutical, a Novato, California-based bio/pharmaceutical company, reports  that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its biologics license application (BLA) for UX111 (rebisufligene etisparvovec), an adeno-associated virus (AAV) vector gene-therapy for treating Sanfilippo syndrome Type (MPS IIIA). A a rare lysosomal storage disease that primarily affects the brain and is characterized by rapid neurodegeneration with onset in early childhood. The product was originally developed by Abeona Therapeutics and transferred to Ultragenyx to complete development.. 

In the CRL, the FDA requested that the company provide additional information and improvements related to specific aspects of CMC (chemistry, manufacturing, and controls) and observations from the recently completed manufacturing facility inspections. The company believes that these observations are readily addressable, related to facilities and processes, and are not directly related to the quality of the product. The company will be working with the FDA over the next few months to resolve the observations. Once resolution is achieved, the company expects to resubmit the BLA and anticipates up to a six-month review period to follow the resubmission (as reported on July 11, 2025). 

Source: Ultragenyx Pharmaceutical 

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Cellular Origins, Catapult, Resolution Therapeutics Form Consortium for Automated Cell-Therapy Mfg  
Cellular Origins, a cell- and gene-therapy company, the Cell and Gene Therapy Catapult (CGT Catapult), a technology and innovation organization, and Resolution Therapeutics, a clinical-stage bio/pharmaceutical company, have announced the formation of a consortium for automated cell-therapy manufacturing 

The project commenced on July 1, 2025, and will last for 20 months and is supported by a £1- million ($1.34-million) grant from Innovate UK, UK’s national innovation agency. 

Source: Resolution Therapeutics