Next Gen Editing helps CRISPR/Cas9 and gene therapy companies build off-target safety packages that pass FDA review, design IND/BLA-ready research reports, and avoid clinical hold. Led by Andrew Kernytsky, who established the on- and off-target gene editing platform for exa-cel — the world's first company-sponsored CRISPR clinical trial — at CRISPR Therapeutics.
Drosophila Wing Cells: CBFA2T3-GLIS2 fusion protein (red), nuclei (green), and actin filaments (purple).
Bringing drugs from inception to the clinic is our specialty. We design and execute successful off-target analysis for all types of therapeutics.
We can help edit DNA, insert large payloads, and accurately quantify and improve the effectiveness of these changes.
Since DNA sequencing was revolutionized by Next Gen Sequencing, we've been working on the algorithms behind it. Heck, we even made it the company name!
FDA. EMA. MHRA. Hooray! Getting regulators to understand your DNA editing strategy and approve your therapy is what we're all about.
Computers and biology are our bread and butter. Peanut butter and jelly. You get the idea - we do all sorts of other analyses: epigenetics, gene expression, single cell analysis.
New venture pitches and academic projects take careful evaluation to decide whether they warrant funding. We can help evaluate and guide them.
Posts about gene editing, consulting, best practices, FAQs, investing
The April 2026 draft guidance on NGS-based safety assessment for genome editing therapies finally codifies a lot of what reviewers were already asking for in pre-IND meetings. Here's what's new, what isn't, and where sponsors still have to make the call.
A guide to writing research reports that enable IND, CTA, and NDA submissions.
FAQ about off-target editing and best practices
Edit DNA faster.
Analyze data better.
Build amazing companies.Let's discuss what we can do together