Biotech, biologics & advanced therapies
From cell line to GMP lot, with unbroken genealogy
HDLIMS gives discovery, process development and QC teams one shared data model, so knowledge built at bench scale carries through tech transfer, and every GMP lot traces back to its cell bank, raw material lots and process parameters.
The challenge
The challenges we hear most
Research and QC on separate islands
Research runs on an ELN, QC runs on a LIMS, and the two rarely agree on sample IDs, material names or assay versions. Reconciling them becomes someone’s job at every phase transition.
Knowledge lost at tech transfer
Process development data sits in notebooks, spreadsheets and slide decks. Receiving sites and CDMOs rebuild methods and parameter ranges from documents instead of structured, reviewable records.
Genealogy across dozens of inputs
A single drug substance lot draws on cell banks, media, buffers, resins and intermediates. Reconstructing that tree for a deviation or an information request takes days of manual tracing.
Chain of identity is non-negotiable
In autologous cell and gene therapy, a patient’s material must stay matched to that patient from collection to infusion. Manual handoffs between sites, couriers and the lab are where mix-ups begin.
Capabilities
How HDLIMS supports Biotech & Biologics
Preconfigured workflows, terminology and reports for your industry, on the same unified platform.
Structured process development ELN
Capture runs, parameters and outcomes as structured data rather than prose, so DoE results, proven acceptable ranges and control strategies stay searchable and reusable.
Batch and material genealogy
Trace any lot backward and forward through cell banks, media, resins, intermediates and fill-finish, down to the individual vial.
Chain of identity and custody
Patient-specific identifiers, barcode verification at every handoff and custody logs keep autologous material matched from collection to final product.
Bioassay and plate-based data
Plate layouts, curve fitting, relative potency and system suitability for ELISA, cell-based potency, qPCR and other plate-based methods.
Tech transfer packages
Bundle methods, specifications, process parameters and supporting data for a receiving site or CDMO as versioned, reviewable records.
Phase-appropriate controls
Work with lightweight ELN controls in discovery, then switch on GMP signatures, audit trails and review steps as programs move into the clinic.
Workflow
From process development to released lot
- 1
Develop
Scientists record runs and DoE studies in the ELN against registered cell lines and materials.
- 2
Transfer
Approved parameters, methods and specifications move to manufacturing or a CDMO as versioned records.
- 3
Manufacture
In-process samples register against the batch, and consumed material lots link in to build genealogy.
- 4
Test
QC runs release and characterization assays, with plate data and curve fits captured from instruments.
- 5
Release
QA reviews genealogy and results together, then signs disposition with a Part 11 e-signature.
Regulations & standards
Designed to support your compliance program
HDLIMS provides the technical controls and records these frameworks call for. Compliance remains a property of how your lab configures and operates the system, and our validation package helps you demonstrate it.
Recommended modules
The modules Biotech & Biologics teams use most
FAQ
Biotech & Biologics: frequently asked questions
Can research and GMP teams work in HDLIMS at different levels of control?
How does HDLIMS maintain chain of identity for cell and gene therapies?
Can we trace a final vial back to the master cell bank?
Does HDLIMS support tech transfer to a CDMO?
See HDLIMS configured for Biotech & Biologics
Book a tailored demo with a lab informatics specialist. We map your sample types, methods and compliance requirements, then show you exactly how HDLIMS fits.