DPS Group Tapped by Oncorus to Design GMP Clinical Manufacturing Facility
DPS Group, a privately-owned, global engineering, procurement, construction management and validation (EPCMV) firm serving high-tech process industries, today announced it has been selected by Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, to design a 88,000 square foot Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility on the Innovation Park campus located at 4 Corporate Drive in Andover, Mass.
Oncorus is focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. The company is advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on its oncolytic Herpes Simplex Virus (oHSV) and Synthetic viral RNA (vRNA) Immunotherapy Platforms.
The facility is intended 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 investigational new drug (IND)-enabling studies and clinical studies. Oncorus anticipates the first phase of the facility’s buildout will be completed in 2021, including process development and quality control, with CQV completion and GMP multi-product manufacturing capabilities and full operation commencing in the first half of 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity.
“We selected DPS due to its robust history performing specialized design services in the life sciences industry,” said Brett Belongia, PhD, vice president of CMC operations at Oncorus. “This new GMP viral immunotherapy clinical manufacturing facility demonstrates our commitment to advance innovative treatment solutions aimed at improving outcomes for cancer patients, and our desire to contribute to the long-term success and impact of the Massachusetts biotech sector.”
As developer of the schematic design and construction documents for this facility, DPS is providing architectural, process and MEPFP engineering services in a phased approach for the lab, office, cGMP clinical manufacturing and warehouse design for this exciting chapter in the company’s development. As Oncorus’ CQV partner, DPS authored its project Commissioning and Validation Master Plans, and is providing system start-up and commissioning services in the lab and office portion of the facility. These efforts will directly support future Qualification and Validation efforts in the GMP manufacturing suites to be built in 2022. This will be a multi-product, flex facility for Oncorus’ strong pipeline of curative product with the capacity for future expansion and both clinical and commercial manufacturing.
Serving high-tech industries around the world, DPS Group delivers full-service engineering across a range of disciplines, including project management, procurement, design, construction management, health and safety management, commissioning, qualification, and validation (CQV), and facility start-up.
