The Chatter 2021

Fast-Tracking a State-of-the-Art Clinical Manufacturing Facility

By Jennifer Miller

A/Z Corporation recently partnered with a single-source drug development technology company to support their efforts to accelerate and transform biologics discovery, development, and manufacturing from concept to commercial manufacturing. This company has facilities across Asia, Europe, and North America, including its new 14,000-square-foot clinical manufacturing facility in New Jersey. After identifying the need to become involved in the COVID-19 vaccine production, A/Z was tasked to design and renovate the facility for Current Good Manufacturing Practice (cGMP) operation and clinical manufacturing. This location focuses on the production of monoclonal antibodies (mAb) and recombinant proteins based on mammalian cell culture technology.

With this project’s desired fast-track design and construction, A/Z simultaneously executed a two-phase schedule to achieve the milestone completion date. The first phase involved consolidating equipment and spaces and relocating equipment within the product development and quality control lab spaces. The second phase included the consolidation of equipment and spaces, the relocation of equipment, and the newly designated production and storage space within the cGMP/manufacturing/warehousing area.

“This design-build project had several challenges the team had to navigate, specifically the design, approvals, and overall project schedule,” said A/Z Vice President Scott Loureiro. “The collective team, including A/Z, the owner, the A/E, and our subcontractor partners, came together and stood united on achieving the project’s goals. In my perspective, working with such an outstanding and dedicated team was a highlight throughout the project.”

A/Z’s team oversaw the design, planning, and implementation of renovations that converted and qualified this facility from single-product to multi-product production. The new facility supports drug substance (DS) process development, tech transfer, clinical manufacturing, batch release, DS storage, and stability studies. It primarily contains a Biosafety Level 1 (BSL-1) production area with a potential bioassay lab as BSL-2 to handle special cell-based bioactivity. The reconfigured facility aims to process approximately 15–20 batches per year with the current upstream and downstream line capability of up to 4,000 L scale. From project startup through the final closeout, A/Z was well aware of the high risks associated with this project and ultimately met the project objectives while exceeding the client’s expectations.