“ Advanced therapies rarely follow a standard manufacturing template. Our role is to engineer a robust route from a complex process to reliable patient supply.”
Engineering the Next Generation of Advanced Therapies
Nova Laboratories is combining three decades of innovation in aseptic manufacturing with a major investment in a new four-stream live biologics facility. The aim is to create capacity to support demand for gene therapy manufacture and the next generation of complex medicines.
Gene therapies are biologically sensitive and often technically challenging to process with frozen cold chain requirements. They demand contamination control strategies, adaptable processes and a manufacturing partner able to solve problems. For Nova Laboratories, this is familiar territory. Since 1994, the UK specialist has built its reputation on processing complex sterile products that cannot withstand terminal sterilisation, supporting programmes from early clinical development through to commercial supply.
Pioneering gene therapy manufacture
Nova’ s purpose-built live biologics facility has been operational since 2010, manufacturing CAR-T cell and gene therapies, for clinical and commercial use. Its sterility assurance record is a powerful measure of sustained control with zero contamination growth on any environmental monitoring samples detected within its Grade A isolators since operations began in 2010. Across Nova’ s wider sterile operations, more than three million units have been completed through aseptic process simulations of complex aseptic processes.
This experience has helped clients reach landmark approvals. Nova has been a key partner in programmes including the first FDA-approved CAR-T therapy and the first FDA-approved AAV gene therapy, as well as the first FDA-approved aseptically spray-dried biologic. Each milestone demanded a new manufacturing approach, close collaboration and the confidence to manage uncertainty without compromising quality. Today, five commercial products sit within Nova’ s sterile manufacturing portfolio.
Engineering as a competitive advantage
Rather than relying solely on a one size fits all approach to equipment and external suppliers, Nova’ s dedicated engineering team designs and fabricates isolators, automated fill-finish systems and bespoke production equipment. Replacement parts can be produced from a CAD drawing in as little as 24 hours, reducing supplier dependency and helping technical teams respond quickly when a novel process presents an unexpected challenge. This capability is rooted in more than 30 years of gassedisolator development. Nova’ s bespoke, flexible-walled high-integrity systems provide a Grade A environment while accommodating processes that are difficult to integrate into conventional equipment. The company is now operating its sixth-generation isolator platform, bringing together accumulated operational knowledge, robotics and automated fill-finish technology. Nova’ s industry leading engineering function uses digital design tools, 3D visualisation, virtual reality and computational fluid dynamics to allow equipment, workflows and airflow behaviour to be assessed before construction. That same engineering culture delivered the world’ s first fully validated cGMP aseptic spray dryer approved by both the EMA and FDA. The continuous process offers straightforward scalability and precise control over particle size and morphology, opening options for highconcentration biologics, injectable suspensions and advanced drug-delivery formats. It is a clear example of Nova’ s ability to turn a demanding pharmaceutical objective into a validated manufacturing solution.
A four-stream platform for growth
Nova is now applying this experience to a major investment at its established site in Leicester. The new live biologics development is conceived as a four-stream sterile fill-finish facility for gene therapies and other advanced therapy medicinal products. Detailed design work is currently focused on equipment for the first line, designed around processing glass vials, with three further automated manufacturing lines to follow.