Syner-G Partners with Leading Supplier in Life Sciences to Build Out New cGMP Compliant Facilities

As production for COVID-19 vaccines ramped up, a world leading supplier was presented with a significant challenge: they needed to rapidly scale up the production capacity of animal-origin free enzymes. This initiative would require the construction and validation of two new US-based manufacturing facilities. Given the time constraints and the magnitude of the project, this leading supplier partnered with Syner-G’s local San Diego team of reputable consultants to successfully scope, staff, and execute the two bioprocessing facility design and construction projects. Projects of this size and scope typically require a minimum of 3
months for planning and preparation, however, the team at Syner-G hit the ground running and leveraged their deep industry expertise in quality, technical operations, scientific operations, and program management to accelerate the thorough planning phase of this project to a duration of only 3 weeks.

Despite timeline challenges, due to supply chain shortages and delays, Syner-G successfully coordinated the design and construction of the two new cGMP biomanufacturing facilities in under 12 months – a combined total of more than 250,000 ft2. The newly designed facilities included multiple modular cleanrooms, dual site QC laboratories, warehouses, and final packaging areas to support three unique product lines.

In tandem with completing the facility buildouts, Syner-G also facilitated the complex international technology transfer from the client’s site in Lithuania to the newly constructed US bioprocessing sites. To support this project, Syner-G provided specialized quality expertise to translate and update quality documentation to fit North American standards and assembled a team of subject matter experts to conduct proactive risk assessments, develop a quality management system (QMS), author standard operating procedures (SOPs), and execute on commissioning, qualification, and validation (CQV) activities.

Syner-G’s specialized and flexible approach was instrumental in securing the overall project timeline for simultaneously completing the technology transfer and facility build-out efforts. Syner-G was honored to partner on this project and rise to the challenge of scaling this leading supplier’s cGMP manufacturing operations to support the ramp-up of COVID-19 vaccine production.