CAMBRIDGE, MA — Global contract manufacturing organization Symbiosis Pharmaceutical Services, with offices in Cambridge, MA, recently passed a key inspection by the US Food and Drug Administration (FDA) for its facilities in Scotland.
Headquartered in Stirling, UK, Symbiosis specializes in the sterile manufacturing of pharmaceuticals and biopharmaceuticals for clinical trials, as well as the supply of commercial markets. During the FDA inspection in January 2025, the company received zero Good Manufacturing Practice (GMP) observations, marking another significant milestone for Symbiosis.
This achievement reinforces Symbiosis’ global reputation as a trusted partner in biologics sterile manufacturing, particularly in the “fill/finish” process. The company’s regulatory excellence, commitment to quality-driven manufacturing, and adherence to industry-leading compliance standards were highlighted in an official statement.
The FDA inspection, which took place over seven days, focused on the ongoing fill/finish of an Adeno-Associated Virus (AAV) viral vector biologics product for a long-term US pharmaceutical client. The successful outcome validated Symbiosis’ robust quality management systems, ensuring continued compliance with FDA regulations and solidifying the company’s ability to deliver high-quality biopharmaceutical manufacturing solutions globally.
In response to the evolving regulatory landscape, Symbiosis has expanded its quality function with the recruitment of experienced professionals, enhancing process controls and risk management frameworks to maintain a state of continuous regulatory readiness.
Colin MacKay, CEO of Symbiosis, commented: “This successful FDA inspection outcome reflects our team’s expertise and ongoing commitment to quality excellence. In a rapidly changing biopharmaceutical environment, regulatory rigor and GMP operational performance remain top priorities for us. We are proud to provide our clients with unwavering confidence in our quality capabilities, ensuring product excellence.”
This successful inspection underscores a key moment in Symbiosis’ growth strategy. The company is further expanding its capabilities with the commissioning of a new state-of-the-art automated sterile GMP manufacturing facility near its existing Stirling location. This new facility will enhance the company’s commercial-scale sterile manufacturing capacity and support a growing client base globally, addressing both clinical and commercial injectable drug product lifecycle challenges.
MacKay added: “Symbiosis continues to thrive as a global leader in fill/finish services, driven by increasing demand for our expertise. As biologics and injectable drugs continue to grow in development, and with a rising demand for outsourced sterile GMP services, we are committed to maintaining high standards of customer service and compliance. This strategy supports our continued organic growth, particularly in the US and European markets.”
