Title21 Health Solutions, a provider of enterprise quality management systems and orchestration software for cell and gene therapy workflows, has acquired MyCellHub, adding a cloud-based manufacturing execution system (MES) to its product portfolio as it pushes to deliver more integrated digital infrastructure for regulated life sciences and advanced therapies.
The deal expands Title21’s capabilities across the advanced therapy medicinal products (ATMPs) value chain, where organizations are increasingly under pressure to digitize and standardize processes while maintaining strict compliance with GMP requirements and regulated documentation practices. Financial terms were not disclosed.
Title21 said the acquisition strengthens its role as a “data bridge” across the advanced therapies ecosystem, aiming to improve transparency and collaboration among therapy developers, contract manufacturers, and clinical providers. By adding MyCellHub’s MES technology, Title21 is positioning itself to offer a broader end-to-end suite spanning standard-of-care workflows, advanced biotherapy manufacturing execution, quality management, and analytics in a single platform approach.
MyCellHub’s MES platform is designed for regulated production environments in healthcare, biotech, and cell therapy manufacturing. Title21 said the technology supports real-time production monitoring, digital batch record management, and embedded quality controls within manufacturing operations—areas that have become central as advanced therapy programs scale beyond early clinical settings and into more complex, higher-throughput commercial and late-stage manufacturing footprints.
The acquisition is also intended to broaden Title21’s geographic reach. Title21 said it already supports customers across North America and Australia, and the addition of Belgium-based MyCellHub extends coverage into Europe, where manufacturers and therapy developers face a similarly stringent regulatory environment and growing demand for traceability, controlled documentation, and faster release cycles.
Title21 characterized the combined offering as a step toward “arm-to-arm” workflow coverage—linking clinical and manufacturing processes that can span collection, chain-of-custody, production execution, quality review, and final documentation. In practice, integrating MES capabilities with quality management and therapy orchestration tools can help reduce manual handoffs, limit transcription errors, and support more consistent adherence to batch protocols, while also creating a consolidated data layer for operational analytics.
MyCellHub, for its part, has focused on replacing paper-based GMP processes with secure digital workflows, including digital batch records designed to meet electronic records and signature requirements such as 21 CFR Part 11. Title21 said the platform is built to support data integrity and process control in environments where deviations, corrective actions, and documentation completeness directly affect both compliance posture and manufacturing velocity.
Title21 is an ArchiMed portfolio company. The firm said the transaction builds on its long-standing position in the life sciences software market and reinforces its strategy of expanding functionality that helps regulated organizations reduce operational risk, increase efficiency, and accelerate development timelines for therapies moving toward broader patient access.
KEY QUOTES:
“This strategic addition to our expanding product portfolio positions Title21 as the leader in arm-to-arm workflow, documentation, and compliance solutions for the developers, manufacturers, and clinical providers of life-saving biotherapies. It also expands our geographic coverage in North America and Australia to include Europe. We welcome the Belgium-based MyCellHub team to Title21 and look forward to adding them to our committed group of professionals advancing Healthcare IT in this important industry.”
Tony Pare, CEO, Title21 Health Solutions
“We founded MyCellHub on the belief that GMP operations should be digital, efficient, and error-resistant. Title21 shares this vision. Their long history of innovation and commitment to patient safety aligns closely with our values and mission. As part of Title21, we will accelerate improvements, benefit from additional resources, and expand the tools available to support life-science organizations.”
Jacques Parlongue, CEO, MyCellHub
