The operating software for cell and gene therapy manufacturing, replacing paper batch records with a compliant digital system.
Visit site ›What they do
The Cell and Gene Therapy Orchestration Platform combines a Manufacturing Execution System (electronic batch records, environmental monitoring, sample tracking, inventory, equipment management, device integration) with an enterprise quality management system, a blood and marrow transplant module, and GMP facilities services. Compliance with FDA 21 CFR Part 11 is the organizing constraint. The enterprise quality management and document control system is the bread and butter of the business and remains the widest entry point. The growth today is in cell and gene therapy and BMT, on both the academic and commercial side, which is where the company increasingly leads. It sells to academic medical centers and commercial manufacturers alike, alongside CAR-T and biotherapeutic manufacturers, CDMOs, blood centers and biobanks, cellular therapy labs, BMT programs, and cancer centers.
Source: title21.comKey facts
What makes them different
Most quality and manufacturing software is adapted from traditional pharma, where a batch is thousands of doses. Cell and gene therapy is a batch of one, per patient, under chain-of-identity and chain-of-custody rules that pharma MES was never designed for. Title21 Health Solutions is built for that case, and sells a configurable integrated suite rather than a set of point tools a customer has to stitch together.
Why KMAK invested
We founded it, and it is where our operators-first mentality comes from. We were the operators. We built the quality and document control systems that hospitals and manufacturers run their compliance on, sat with the people using them, and learned what it actually takes to move a cell therapy program off paper. That is the lens we bring to everything else in this portfolio: we would rather back people doing the hard operational work than people describing it. Title21 Health Solutions also remains the position that does not require any one therapy to win. Every manufacturer, CDMO, and transplant program carries the same regulatory burden regardless of whose science prevails, and too many of them still run it on paper. Watching that problem from the inside is what led us to Siren and Alaya.