Trisk Bio & NanoMosaic Forge FDA-Backed Path for Gene Therapy Quality

STEVENAGE, England & WALTHAM, Mass. – May 11, 2026 – A strategic partnership announced today between UK-based manufacturer Trisk Bio Ltd. and US-based analytics leader NanoMosaic, Inc. is poised to set a new benchmark for quality and regulatory confidence in the rapidly advancing field of gene therapy. The collaboration will deeply integrate NanoMosaic’s Tessie™ analytics platform, which recently secured a first-of-its-kind designation from the U.S. Food and Drug Administration (FDA), into Trisk Bio’s core manufacturing processes for adeno-associated virus (AAV) vectors, the primary delivery vehicle for many gene therapies.

This alliance addresses one of the most significant bottlenecks in the biopharmaceutical industry: the challenge of consistently producing high-quality, safe, and effective AAV vectors at scale. By embedding an FDA-vetted technology at the heart of its operations, Trisk Bio aims to de-risk the complex manufacturing journey for its clients, potentially accelerating the path from lab to clinic for life-changing treatments.

The FDA Advantage: A New Gold Standard for AAV Analytics

The centerpiece of the partnership is the Tessie platform's designation as an Advanced Manufacturing Technology (AMT) by the FDA's Center for Biologics Evaluation and Research (CBER) in January 2026. This is a landmark achievement, making it the first analytical technology for AAV manufacturing to receive such a distinction. The AMT program is designed by the FDA to encourage the adoption of innovative technologies that can improve product quality and streamline manufacturing, ultimately strengthening the drug supply chain.

For gene therapy developers, an AMT designation is a powerful signal of regulatory acceptance. It provides a pre-vetted blueprint that can significantly reduce uncertainty and expedite review timelines for the Chemistry, Manufacturing, and Controls (CMC) portion of a Biologics License Application (BLA). This gives companies partnering with Trisk Bio newfound confidence that their analytical foundation will meet the FDA's stringent expectations.

Trisk Bio’s leadership demonstrated significant foresight by adopting the Tessie platform well before the official FDA designation. "We are pleased to see the FDA validate the advantages that have been clear to us from our first engagements with NanoMosaic," said Gaurav Venkataraman, Trisk Bio CEO. This early commitment underscores a core philosophy at Trisk. "Trisk is oriented around helping our clients become successful by providing high-quality material and de-risking manufacturing from the start," Venkataraman added.

Precision Power: Overcoming Legacy Analytical Hurdles

The need for a next-generation analytical solution stems from the profound limitations of traditional methods. AAV manufacturing is notoriously complex, often producing a heterogeneous mixture of viral vectors. The critical challenge lies in distinguishing functional vectors—those carrying the complete therapeutic gene—from empty or partially filled capsids that offer no therapeutic benefit and can trigger unwanted immune responses.

As Gaurav Venkataraman noted, "Legacy AAV analytics can misread critical quality attributes by orders of magnitude." These legacy techniques, such as certain PCR-based assays and spectrophotometry, often provide indirect or incomplete measurements, struggle with reproducibility, and lack the sensitivity to accurately quantify the full-to-empty ratio. This analytical ambiguity creates significant risks, potentially leading to inconsistent batch quality, inaccurate dosing, and clinical trial delays.

NanoMosaic's Tessie platform directly confronts these issues. Leveraging innovative nanoneedle technology, it enables the simultaneous analysis of both proteins (the AAV capsid) and nucleic acids (the therapeutic gene) on a single chip. This multiomic approach provides a direct, highly sensitive, and specific measurement of critical quality attributes (CQAs). The platform can precisely distinguish full, empty, and partial capsids, providing an accurate profile of the vector population in a fraction of the time and with less sample material compared to older methods. This leap in precision ensures that gene therapy programs are built on a foundation of the most accurate data possible.

Reshaping the AAV Manufacturing Landscape

The partnership arrives at a pivotal moment for the AAV CDMO market, which is projected to grow exponentially, with some estimates predicting a market size of over $3.4 billion by the early 2030s. However, this growth is tempered by persistent manufacturing bottlenecks, quality control concerns, and intense regulatory scrutiny. Small and mid-sized biotech firms, which are at the forefront of gene therapy innovation, often lack the in-house expertise and capital to navigate these challenges, making them heavily reliant on specialized CDMOs like Trisk Bio.

By integrating the FDA-designated Tessie platform, Trisk Bio strategically positions itself not just as a manufacturer, but as a quality-centric partner capable of providing a significant competitive advantage. This integrated solution offers an end-to-end pathway that is analytically robust and aligned with regulatory expectations from the outset. For gene therapy developers, this translates into reduced risk, lower costs associated with failed batches or regulatory setbacks, and a faster route to market.

"Trisk Bio's early commitment to direct, accurate measurement made them a natural long-term partner," said Qimin Quan, PhD, Co-Founder and CSO of NanoMosaic. "Developers working with Trisk benefit from a CDMO with a deep commitment to analytical excellence." This sentiment reflects a broader industry shift, where the choice of a CDMO is increasingly dictated not just by capacity, but by the sophistication of its quality and analytical systems.

Representatives from both companies are scheduled to discuss the partnership and its implications at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. This high-profile venue will provide an opportunity for the wider scientific and clinical community to engage with the technology that promises to ease the manufacturing and comparability burdens that have long challenged the progress of advanced therapies.