Publications

Tech-Transfer and Manufacturing for Scaling Biotech

Artis BioSolutions — Sat, 02 May 2026 01:58:18 GMT

At Advanced Therapies Week 2026, our Chief Technology Officer, Gregg Nyberg, joined a panel of industry leaders to discuss how advanced therapy developers are navigating the path from early-stage process development to commercial manufacturing. The conversation reinforced something we see in nearly every program we support: the hardest part of scaling a cell or gene therapy isn't any single inflection point. It's the series of small, often quiet decisions made years earlier that determine whether the next stage is a smooth translation or a costly reinvention.

Scaling AAV9 Manufacturing: A Blueprint for Clinical-Grade Gene Therapy Production

Artis BioSolutions — Sat, 02 May 2026 01:54:50 GMT

Scalable AAV manufacturing is one of the most persistent bottlenecks in gene therapy. High viral titers through triple transfection are difficult to achieve consistently, and downstream purification using scalable chromatography has been a challenge for the field for years. The constraints get harder for emerging cell and gene therapy programs that also lack access to a robust, license free bioprocess. With support from a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Landmark Bio executed a pilot scale AAV9 batch using the NIIMBL Viral Vector Program's bioprocess framework, with the goal of producing an open source platform that any organization can use to make clinical scale material. In this session, two of the scientists who led the work share what the team learned, including an upstream optimization that delivered a greater than tenfold improvement in viral titer and a downstream effort that scaled production while optimizing chromatography for purity and yield. The result is a practical, transferable framework for AAV9 programs that need a viable path forward to the clinic.

Translating Stem Cell Programs to GMP: A Collaborative Approach to Overcoming Manufacturing Complexity

Artis BioSolutions — Sat, 02 May 2026 01:38:05 GMT

Moving stem cell programs toward GMP manufacturing requires navigating a complex set of process dependent factors that influence identity, function, potency, and safety. Because outcomes are highly sensitive to even small changes in workflow, raw materials, or operator handling, teams routinely encounter obstacles in the transition from research environments to regulated manufacturing. In this discussion, three Landmark Bio experts share practical perspective on the most common challenges teams face: redesigning early stage processes for compliance, addressing operator driven variability, managing scale limitations, securing dependable raw materials, and aligning analytical methods with regulatory expectations. The conversation focuses on how thoughtful program design, structured execution frameworks, and early cross functional planning can improve reproducibility, reduce risk, and accelerate the path from development to clinic.