About the project

Hereva was hired to be the Owner’s Representative for Oncorus, a viral immunotherapies company, as they renovated their new facility; an 88,000 sq. ft. current Good Manufacturing Practice (cGMP) viral immunotherapy clinical manufacturing facility in the Innovation Park campus located at 4 Corporate Drive in Andover, MA.

This is the first cGMP facility owned and occupied by Oncorus. Their goal was to transform the facility into an additional location for cGMP clinical manufacturing, while simultaneously strengthening its corporate brand and regional presence as a global leader in cancer treatment.

The facility was designed to provide a comprehensive solution for Oncorus’ Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality control, and supply of clinical-grade viral immunotherapies for its investigational new drug (IND)-enabling studies and clinical studies.

This was a multiphase expansion project for the Oncorus team. The first phase of the facility’s buildout was the limited renovation of 17,000 sq. ft. of lab facilities completed in July 2021, which included process development and quality control. The next phase consisted of the ground level and first floor loading dock and office space (16,000 sq. ft.) in Q2 2021 followed by the first floor cGMP facility (42,000 sq. ft.) in November 2021. Total project completion was achieved on schedule at the end of 2022, including CQV completion and full GMP multi-product manufacturing capabilities. Full operations are expected to commence in the first half of 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity.

Hereva was involved from the initial property search, including site selection and lease negotiation. We created the master schedule, budget, programming and stage-gate approvals for this project.

Hereva also managed the development team, procurement, relocation and operational startup. We helped select DPS as the design team and assisted the team in creating new P&ID (Piping and Instrumentation Diagrams). Our work continued through project completion and operational startup

The project is in a multi-tenant building that had not previously housed cGMP operations. One of the biggest challenges we faced was in building out cleanroom suites for a process that, at the time, was undefined.

About the client

Oncorus is focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. They are advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on their oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform.

For more information visit www.oncorus.com.

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