Skye Biologics are at the forefront of advancing regenerative biologic therapies, utilizing donor placental tissue to produce a pipeline of therapies aimed at addressing unmet needs across various clinical areas.
The challenge.
Skye Biologics manufactures BioECM® allografts from donor placental tissue. A complex, multi-step process where every unit traces back to a specific donor and must meet FDA requirements for human tissue products.
Their manufacturing was paper-based. Batch records were handwritten. Lot genealogy. Tracing a finished allograft back through every processing step to the original donor tissue. Required pulling physical records and manually cross-referencing them. When yield dropped on a production run, finding the root cause meant searching through paper records across multiple process steps.
The team knew where the problems were. Rework rates were higher than they should have been, but without queryable data, they couldn't pinpoint which steps were driving the issues. Audit preparation consumed days of assembling documentation. Every new product variant required duplicating paper templates and hoping nothing was missed.
What changed.
Skye evaluated multiple vendors and chose Seal because it covered the full scope. Document control, training, batch records, supplier management, inventory, environmental monitoring, and instrument integration. On one platform. No stitching together point solutions.
The transition moved batch records from paper to guided digital workflows. Operators followed the same process steps on screen, but now every weight, measurement, and observation was captured digitally as it happened. Lot genealogy became automatic. The system tracked every donor tissue lot through every processing step to every finished unit without manual cross-referencing.
Environmental monitoring data flowed directly from instruments into the system. Temperature excursions, particle counts, and microbial results linked automatically to the batches produced in those conditions. When an environmental alert triggered, the system already knew which batches were affected.
Labeling. Previously handled by a separate dedicated tool. Moved onto the same platform. Labels generated from batch data, eliminating the transcription step between the batch record and the label printer.
The outcome.
Batch record review time dropped by 50%. Reviewers stopped checking every handwritten entry and started reviewing system-flagged exceptions. The review that used to be a multi-day exercise for complex batches now completed in hours.
Audit findings decreased by 40%. Not because the team prepared better binders, but because the system enforced the controls that auditors check. Training current before execution, procedures at the right version, deviations linked to CAPAs. The compliance was integrated into the workflow, not assembled for the audit.
The 35% efficiency gain came from places the team hadn't predicted. Labeling automation eliminated a dedicated tool and its associated manual steps. Data from batch records enabled the team to identify which specific process steps drove rework. And fix them. Real-time visibility into production status replaced the daily status meetings where supervisors pieced together progress from paper records.
Full lot genealogy. Donor tissue to finished allograft. Went from a manual reconstruction exercise to an instant system query. When a customer or regulator asked about a specific unit, the answer was immediate.
From the team.
“With Seal, we could quickly transform our existing processes into a digital form. We didn't need to adapt or change them, and even better, it evolves with us as we scale. The support has also been outstanding.”
Start with one job.
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