Abzena selects IPS for design and build of turnkey cGMP facility

2022-06-22 14:14:58 By : Mr. frank lin

Biopharma expert Abzena has chosen IPS to perform full design, construction management, and CQV services for its new monoclonal antibody (mAb) facility

IPS-Integrated Project Services, a provider of engineering, procurement, construction management, and validation (EPCMV) services, has announced its support to Abzena (North Carolina) to perform full design, construction management, and CQV services for their new monoclonal antibody (mAb) facility.

Abzena's new 120,000 sqft facility in Sanford, North Carolina will expand its current contract manufacturing footprint for cGMP biologics manufacturing. The new facility will house up to four suites, each with 2x2kL single-use bioreactors, and accommodate its Phase 3 clinical and commercial manufacturing capabilities of their CDMO biologic products.

This site will be Abzena's sixth in a global network providing integrated solutions and will be dedicated to cGMP manufacturing capacity for mammalian biologics. Additionally, the facility will be equipped to accommodate flexibility in manufacturing operations such as continuous manufacturing and perfusion.

Abzena initially selected IPS because of their progressive Inceptioneering offering

Once completed later this year, Abzena plans to add up to 325 jobs to the local community.

"Abzena initially selected IPS because of their progressive Inceptioneering offering, which allowed us to create a concept design quickly. After working with IPS further, there was no doubt that we would continue our relationship as a partner in engineering and construction. We are extremely pleased with the level of talent, the partnership in solving issues, and the level of their work," said Kimball Hall, President and Chief Operating Officer of Abzena.

The IPS team provided site agnostic Inceptioneering and pre-construction services to help Abzena make an informed site selection. This up-front work quickly clarified programme requirements and established the required building size, funding, and schedule criteria.

Abzena's clients need more capacity, and that is driving the aggressive schedule.

Abzena ultimately selected a site based in North Carolina, and IPS' local office in the Raleigh area provided continuity for a turnkey delivery with a large local team.

IPS' design services for Abzena's mAb facility include architectural, process, mechanical, electrical, plumbing, fire protection, automation, civil, and structural engineering. Pre-construction services include planning the schedule, execution, and estimation of the new facility.

"Abzena's clients need more capacity, and that is driving the aggressive schedule. We value the relationship and trust we have built with Abzena and are tackling the project challenges together to achieve ambitious goals and help them meet the demand," said Keith Higgins, Southern California Business Unit Leader.

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IPS' procurement and construction management teams provide the equipment and oversee the construction, and the CQV team provides commissioning, qualification, and validation leadership and support. The different departments integrate to ensure that Abzena's new facility will be delivered within their schedule and budget.

"IPS is proud to partner with Abzena to help expand their manufacturing capabilities and better serve their patients worldwide," said Jacob Stephen, IPS' VP of Operations - Americas. "It is clear that Abzena and IPS' passion to collaborate with one another will result in an innovative project that will benefit the local community and beyond for years to come."