Customer Success
Preparing Cell and Gene Therapy GMP Operations for Scale
A clinical-stage cell and gene therapy company needed to replace paper-based GMP processes as it prepared for commercial scale. Labbit provided a connected, configurable system for managing QC, manufacturing, traceability, and compliance while supporting future growth.
The Situation
A privately held, clinical-stage biotech company focused on developing therapies for a targeted chronic illness was preparing to scale toward commercial operations, but GMP laboratory and manufacturing processes were still largely paper-based.
The company’s technology uses living cells engineered to continuously produce a therapeutic protein at the site of disease. To scale their increasingly complex QC, sample, and manufacturing workflows, the company needed a LIMS.
Sample intake, chain of custody, batch records, and equipment logs were all managed on paper which sufficed while in its early stages. However, these processes became a constraint as the volume and complexity of the work grew.
The Limits of Paper-Based Systems
Paper records created problems for the team on two fronts.
1. Paper inhibits collaboration and speed.
- The team's paper-based workflows captured sample management, batch records, chain of custody, and equipment across separate forms and logbooks, which made data difficult to connect.
- There was also limited visibility into sample history, workflow performance, and operational trends.
2. Paper can’t keep up with regulatory requirements.
- As the company approached commercial scale, it needed stronger traceability, data integrity, and compliance controls.
- Manual transcription, calculations, handoffs, and record reconciliation also created additional work and introduced opportunities for error.
Building a Digital System
The team needed a LIMS that could serve as a primary repository for GMP data across both the laboratory and manufacturing floor, with flexible, configurable workflows. This included sample and batch genealogy, location and custody tracking, audit trails, electronic approvals, equipment controls, and reporting. They needed the ability to ask questions about a sample, a reagent lot, or an equipment log, and feel very confident in the answer.They chose Labbit because it met three key requirements:
- A single platform. Labbit is providing LIMS, electronic batch records (EBR), and electronic logbooks on a single platform today, and other responsibilities will be moved to Labbit in the future. Additionally, the platform adapts to the company's specific processes, allowing them to avoid separate systems or forcing rigid workflows.
- Automatic flagging and routing. Labbit can apply predefined business logic to evaluate results, flag exceptions, and automatically route samples to the appropriate next step. This reduces reliance on manual review to detect issues and helps keep samples moving through the correct process.
- A strong audit trail. Labbit captures every action and system change in an immutable audit trail, while connecting samples, reagents, instruments, results, and workflow steps across the full sample lifecycle for clear, end-to-end traceability.
Flexible, Phased Implementation
The company rolled out Labbit in phases so they could evolve implementation as processes matured.
- Discovery phase. Labbit worked with the team to understand its evolving QC processes, define system requirements, and determine what should be digitized at each stage. This created a phased implementation plan that could evolve alongside the company’s processes.
- Flexible configuration. Workflows were mapped directly from the company's existing SOPs and forms into BPMN diagrams within Labbit. This enabled the implementation team to use the company's actual records and processes instead of approximating them in rigid software.
- Lower upgrade burden. Because the build stayed in configuration rather than custom code, future upgrades won't carry the high validation burden typically associated with a heavily customized LIMS.
Looking Ahead
Already, the company is seeing early benefits from implementing Labbit:
- Faster and more reliable answers. With QC and manufacturing data living in one connected system instead of scattered across paper forms and logbooks, teams can bring together manufacturing batch records, environmental monitoring data, and QC results to make real-time quality decisions and support final QA review in one place.
- Proactively surface upcoming requirements. Labbit can flag time-sensitive activities before they become compliance issues, such as a reagent approaching its retest window or a freezer nearing its required swabbing interval (for environment monitoring).
- Stronger foundation for regulatory submission. Because records live in one searchable system, the team is building the kind of complete, traceable data set that supports faster, more complete regulatory submissions and audits.
Conclusion
The company set out to scale its commercial operations, but its paper-based systems couldn’t keep pace with increasing volume and complexity. To address that gap, the team partnered with Labbit to create a connected digital foundation with searchable records, reliable data, and greater flexibility for future growth.