Abzena, a contract manufacturer of biologics and antibody drug conjugates, has completed a facility remodeling for a new antibody-drug conjugate (ADC) GMP manufacturing suite at its Bristol, Pennsylvania site.

The facility is being equipped with 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 part of Abzena’s integrated ADC capabilities for the design, development and manufacture of ADCs. The facility and equipment verification and qualification for the Bristol ADC GMP manufacturing suite is currently underway and is scheduled for completion around the end of the second quarter of 2018.

The Bristol ADC manufacturing suite adds to the company’s 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, California. Abzena says plans are on track for the initial relocation for its biologics manufacturing process and analytical development groups into a new facility in San Diego during April 2018.

Abzena has client process development programs scheduled for the Bristol ADC manufacturing facility, including an ADC using the company’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.

Source: Abzena