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Lonza Completes First GMP Batch at Mammalian Mfg. Facility

New 2,000L asset will support small- to mid-volume products, such as therapies targeting rare diseases.

By: Kristin Brooks

Managing Editor, Contract Pharma

Lonza, a global development and manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, completed the first GMP product batch supported from the recently completed next-generation mammalian manufacturing facility in Portsmouth, NH.  

The first GMP batch release marks a milestone, allowing the facility to help meet the increasing market demand for small- to mid-scale volumes of mammalian-derived biologics and support the implementation of high-titer and high-throughput platform processes.
 
Small-scale bioreactors offer flexibility, including reduced initial capital investments and lower operational costs, which help mitigate volume forecasting challenges during product launches, according to the company. Leveraging advancements in process analytical technology, optimized production processes, and enhanced drug output, along with Lonza’s BLA services, the new facility aims to provide customers with a reliable route to market for various molecule types. It also complements the existing commercial mammalian-derived product manufacturing at 6,000L and 20,000L scales provided from the Portsmouth site and plays a critical role in our ability to support our customers across their entire product lifecycle, according to the company.
 
Stefan Egli, Head of Mammalian Business Unit, Lonza, said, “We are excited to have completed the first GMP batch at our Portsmouth facility. This milestone is a testament to our commitment to delivering industry-leading manufacturing services to our customers, highlighting our continued efforts to support our customers’ needs across their product lifecycle and meet growing market demand for the launch scale. The new 2,000L asset will support small- to mid-volume products, such as innovative therapies targeting rare diseases, and provides the flexibility required for efficient product launches and sustainable lifecycle management across our manufacturing network.”

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