Abzena: Manufacturing suite remodel supports ADC production for preclinical, early-phase studies

By Melissa Fassbender contact

- Last updated on GMT

The FlexAct system from Sartorius consists of the central operating module offers a variety of configuration options. (Image: Abzena)
The FlexAct system from Sartorius consists of the central operating module offers a variety of configuration options. (Image: Abzena)
Abzena has completed a remodeling of its new antibody-drug conjugate (ADC) GMP manufacturing suite, which will support customers progressing drug development programs from research into clinical trials.

The Bristol, PA-based facility is being outfitted with Sartorius and GE single-use equipment and will enable Abzena to produce antibody-drug conjugates (ADCs) for preclinical and early phase clinical studies.

“The remodeling involved the construction of a suite of GMP cleanrooms in which ADC bioconjugation manufacturing will be carried out,”​ explained Sanjeevani Ghone, vice president and site head, Abzena, Bristol PA.

The remodeling also included the construction of two process chemistry labs to support larger-scale linker-payload production, he told us.

“This new capability means we can support our partner companies through the development and manufacturing continuum to ADC drug substance within one company,” ​added Min Park, global head of marketing.

The company recently entered into a master services agreement for an ADC manufacturing program with a US biotech company in a deal valued at more than $5m, said Ghone.

Verification and qualification at the new facility is currently underway and is scheduled for completion around the end of the second quarter of 2018.

“Abzena will continue to take important strategic steps in the delivery of our integrated solution and technology model,”​ Park said. “The combination of state-of-the-art facilities, solutions and leading technologies will enable Abzena to support its international customers as they progress their drug development programs from research into clinical trials.”

Abzena is also upgrading and expanding its biologics process development and manufacturing capabilities in San Diego. According to the company, relocation of its biologics manufacturing process and analytical development groups into the new San Diego facility is expected during April 2018.

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