Abzena, a the life sciences company providing proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products, including antibody-drug conjugates or ADCs, confirmed that it has completed the facility remodeling for its new antibody-drug conjugate or ADC cGMP manufacturing suite at its Bristol, Pennsylvania 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 enables Abzena to produce antibody-drug conjugates for pre-clinical and early phase clinical studies. The suite is a significant part of Abzena’s integrated capabilities to support the design, development and manufacture of antibody-drug conjugates throughout a product’s lifecycle.
The facility and equipment verification and qualification for this antibody-drug conjugates cGMP manufacturing suite is currently underway, and scheduled for completion around the end of the second quarter of 2018.
Expanding ADC chemistry solution
Completion of the cGMP ADC manufacturing suite construction marks a key point in the company’s program to significantly expand the Group’s integrated ADC chemistry solutions. This ADC manufacturing suite complements the existing cGMP 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.
As part of a large investment and expansion program, the company installed of a new 500 L BIOSTAT® STR, single-use bioreactor, in its San Diego process development and manufacturing operations. This expansion is in response to a general demand in the marketplace and the need of many legacy clients with clinical successes for larger volume production capabilities.
In addition, the company’s 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. This biopharmaceutical manufacturing facility provides world-class cGMP manufacturing utilising single use technology for cost effective production.
Additional expansion including further 500 L capacity and up to 2000 L capacity are expected to be available in Q1 2019.
The company 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 benefited from an integrated programme 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. Our recent contracts are a testament to our client’s confidence in our expertise and experience in this field,” noted Sanjeevani Ghone, Vice President and Site Head, Abzena, in Bristol.