Abzena has completed the facility remodeling for its new antibody-drug conjugate (ADC) GMP manufacturing suite at its Bristol, PA site.

The facility is being equipped with state-of-the-art Sartorius and GE equipment for single use scale-up, manufacture and purification processes. The environmentally controlled suite will enable Abzena to produce ADCs for preclinical and early phase clinical studies. The suite is a significant part of Abzena’s integrated ADC capabilities for the design, development and manufacture of ADCs.

The facility and equipment verification and qualification for this ADC GMP manufacturing suite is currently underway, and scheduled for completion around the end of the second quarter of 2018.

Completion of the GMP ADC manufacturing suite construction marks a key point in Abzena’s program to expand the group’s integrated ADC chemistry solutions. This ADC manufacturing suite complements the existing GMP manufacturing capability for the scale-up and manufacture of highly potent payload-linker constructs, and the upgrading and expansion of Abzena’s biologics process development and manufacturing capabilities in San Diego. The plans are on track for the initial relocation for Abzena’s biologics manufacturing process and analytical development groups into the new San Diego facility during April 2018.

Abzena has existing client process development programs scheduled for the Bristol ADC manufacturing facility including an ADC utilizing the group’s proprietary ThioBridge conjugation technology and another that has benefitted from an integrated program comprising cell line development, antibody production and development and manufacture of the ADC product including the linker-payload reagent.

“The completion of this facility is a significant step in realizing Abzena’s vision of being a full service and technology provider for the design, development and manufacture of ADCs,” said Sanjeevani Ghone, vice president and site head, Abzena, Bristol PA. “Our recent contracts are a testament to our client’s confidence in our expertise and experience in this field.”