What is BioPharma LIMS?

LabWare BioPharma is LabWare's laboratory informatics solution for biopharma labs. It combines LIMS and ELN on one configurable platform that covers the biopharma chain from raw materials through lot release, for labs of every size, from startups to enterprise manufacturers.

How long does it take to implement LabWare BioPharma?

LabWare BioPharma can be implemented in less than 30 days. Deployment timelines depend on customer resources and requirements. It can be discussed in detail with a LabWare team member, who can scope it to your lab's workflows, instruments, and systems.

What deployment options does LabWare BioPharma offer?

LabWare BioPharma can be deployed as software as a service (SaaS), hosted, or in your own cloud (bring your own cloud). The right deployment path depends on your go-live timeline, resources, and requirements, and LabWare sales can help you choose.

Does LabWare support both GMP and non-GMP users in the same system?

Yes. LabWare supports GMP and non-GMP workflows within a single system, with configurable controls that apply the appropriate level of validation and audit trail to each workflow.

Can LabWare handle small molecule and large molecule (biologics) workflows in one platform?

Yes. LabWare's configurable workflow engine supports small molecule and large molecule testing within the same platform, including monoclonal antibodies, biosimilars, and vaccines.

How does LabWare integrate with contract manufacturing organization (CMO) and contract research organization (CRO) partner data?

LabWare's approach to CMO and CRO data aligns with the DISCO playbook. Its open architecture and interoperability tools connect to partner systems, reducing manual data entry from partner reports, and configurable data capture templates can be built to match a specific partner's reporting format.

What compliance standards does LabWare support out of the box?

LabWare LIMS and ELN are designed to support the technical controls required under 21 CFR Part 11 and EU Annex 11, including audit trails, electronic signatures, and access controls, and are built to align with ISO 17025 requirements for testing laboratory competence. Validation remains the responsibility of the regulated organization.

Can LabWare scale from a 10-person startup lab to an enterprise biopharma manufacturer?

Yes. LabWare BioPharma supports biopharma labs of every size, and any of LabWare's deployment options can meet the needs of an enterprise biopharma manufacturer. It is one solution, so a lab does not need to switch systems as it grows.

How does LabWare compare to other biopharma LIMS platforms?

LabWare has built laboratory informatics since 1987 and supports more than 30,000 laboratories worldwide. The best way to evaluate fit against a specific alternative is a demo scoped to your lab's own workflows and instruments.

What is BioPharma LIMS?

LabWare BioPharma is LabWare’s laboratory informatics solution for biopharma labs. It combines LIMS and ELN on one configurable platform that covers the biopharma chain from raw materials through lot release, for labs of every size, from startups to enterprise manufacturers.

How long does it take to implement LabWare BioPharma?

LabWare BioPharma can be implemented in less than 30 days. Deployment timelines depend on customer resources and requirements. It can be discussed in detail with a LabWare team member, who can scope it to your lab’s workflows, instruments, and systems.

What deployment options does LabWare BioPharma offer?

LabWare BioPharma can be deployed as software as a service (SaaS), hosted, or in your own cloud (bring your own cloud). The right deployment path depends on your go-live timeline, resources, and requirements, and a LabWare team member can help you choose.

Does LabWare support both GMP and non-GMP users in the same system?

Yes. LabWare supports GMP and non-GMP workflows within a single system, with configurable controls that apply the appropriate level of validation and audit trail to each workflow.

Can LabWare handle small molecule and large molecule (biologics) workflows in one platform?

Yes. LabWare’s configurable workflow engine supports small molecule and large molecule testing within the same platform, including monoclonal antibodies, biosimilars, and vaccines.

How does LabWare integrate with contract manufacturing organization (CMO) and contract research organization (CRO) partner data?

LabWare’s approach to CMO and CRO data aligns with the DISCO playbook. Its open architecture and interoperability tools connect to partner systems, reducing manual data entry from partner reports, and configurable data capture templates can be built to match a specific partner’s reporting format.

What compliance standards does LabWare support out of the box?

LabWare LIMS and ELN are designed to support the technical controls required under 21 CFR Part 11 and EU Annex 11, including audit trails, electronic signatures, and access controls, and are built to align with ISO 17025 requirements for testing laboratory competence. Validation remains the responsibility of the regulated organization.

Can LabWare scale from a 10-person startup lab to an enterprise biopharma manufacturer?

Yes. LabWare BioPharma supports biopharma labs of every size, and any of LabWare’s deployment options can meet the needs of an enterprise biopharma manufacturer. It is one solution, so a lab does not need to switch systems as it grows.

How does LabWare compare to other biopharma LIMS platforms?

LabWare has built laboratory informatics since 1987 and supports more than 30,000 laboratories worldwide. The best way to evaluate fit against a specific alternative is a demo scoped to your lab’s own workflows and instruments.

Laboratory Software for Biopharmaceutical & Biotechnology Labs

One platform that supports quality at every step of your development & production process.

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⚡️ Launch in Under 30 Days

Trusted by 21 of the top 25 biopharmaceutical companies in the world

All-in-one LIMS for Biopharmaceutical Development & Manufacturing

Free scientists from manual QC tasks to focus on product development.
Replace isolated data systems with one connected LIMS & ELN.
Shorten delivery time for batch release & stability data.
Support the accuracy and consistency of biopharmaceutical lab data.
Support current and future regulatory compliance requirements.
Reduce IT footprint with one infrastructure and one database.

Cell Line Development & Cell Banking

Track cell line development from clone selection through master and working cell banks, with full genealogy and storage location history for every vial.

Upstream & Downstream Processing

Capture bioreactor parameters, purification steps, and chromatography runs in one workflow, with data capture aligned to GMP from cultivation through formulation.

Biopharmaceutical Product Release Testing

Product Release Testing

Manage the full release panel (potency, purity, identity, safety) against product specifications, with built-in pass/fail logic and QA review.

Media & Buffer Formulation

Manage formulation recipes, lot tracking, and expiration dates for the media and buffers that feed upstream and downstream processes.

Inventory Management

Track reagents, reference standards, consumables, and critical raw materials with expiry, lot, and storage location, so you never run a GMP test with expired material.

Sample Logistics

Track samples from collection through shipment, receipt, and storage with full chain of custody and shipping conditions recorded at every handoff.

Lot Management

Track batches and lots from raw material receipt through finished product release, with full genealogy back to source materials.

Stability Management

Coordinate stability protocols, pull schedules, and trending across multiple studies and storage conditions in one module.

Environmental Monitoring

Schedule and track EM across cleanroom zones, with configurable sampling frequency and automatic flagging when results fall outside action or alert limits.

LabWare MOBILE

Walk your environmental monitoring route, scan each sampling point, and log plates as you go. Results reach LabWare before you leave the suite.

LabWare ELN

Record process development experiments and plate-based assay data in an ELN built on the same LIMS platform, giving you one source of truth with no system handoffs.

Instrument Interfacing

Connect lab instruments directly to LabWare to remove manual transcription, with native drivers for common biopharma QC instrumentation.

The LabWare Difference

One Digital Thread Across the BioPharma Lifecycle

Stop trying to customize a rigid LIMS solution or cobble together disparate point solutions at every handoff. LabWare provides a holistic, configurable solution that covers the end-to-end biopharma process, from research through QC and manufacturing.

LabWare BioPharma Upstream & Downstream r3-1

Gene Therapy

Viral vector and cell therapy manufacturing, from process development through commercial release.

Monoclonal Antibodies

Batch and lot management built for high-volume, high-value biologics manufacturing.

Cell Therapy

Identity, purity, potency, viability, and microbial test results tracked against specification, from cell expansion through batch release.

Vaccines

Testing, trending, and KPI dashboards for vaccine QC labs, with results tied to each production batch.

Biosimilars

Release testing, stability studies, and lot trending for biosimilar development and manufacturing, with results held against product specifications.

Biotech

Scalable LIMS for biotech labs moving from formulation into clinical and commercial production.

Bioprocessing

Upstream and downstream process data captured in one system, from bioreactor to release.

CDMO

Multi-client, multi-process manufacturing with lot-level traceability and client-facing reporting.

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“The LabWare platform is highly flexible to accommodate nearly any lab process in any industry.”

Jason Gardner

Associate Director, Merck

★★★★★

Built for the standards that govern biopharma labs

Regulatory Compliance

LabWare LIMS and ELN support the technical controls required under 21 CFR Part 11 and EU Annex 11, including audit trails, electronic signatures, and access controls.

LabWare supports the data and documentation requirements of the GMP regulations that govern biologics QC, including 21 CFR Parts 210/211 and 600–610 and EU GMP, including Annex 1 for sterile manufacturing. Specifications can be structured to follow ICH Q6B for biotechnological products. For contract testing labs, LabWare also supports ISO/IEC 17025 accreditation requirements.

21 CFR Part 11 EU Annex 11 GMP GLP

Manage Every Biologics Release Testing Type

Laboratory Management

From antibodies to cell therapies, every lot is released against a product-specific specification. LabWare manages the methods, limits, and results for each category below and carries them through to the certificate of analysis.

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LabWare Pharma/BioPharma Solution

Whether you're working on vaccine development, monoclonal therapies, biosimilars, or any other biologics, LabWare is there with the most functionally rich, flexible, and robust laboratory informatics platform available.

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PRE-CONFIGURED FOR BIOPHARMA

Launch Quickly with LabWare BioPharma

If speed is critical, LabWare BioPharma can launch in under 30 days with best-practice biopharmaceutical workflows already in place.

As your programs and requirements grow, you can add capabilities at your pace. One platform, growing with your team. No reimplementation, switching vendors, or rebuilding your data history.

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How Teams Grow with LabWare BioPharma

Prebuilt workflows

Out-of-the-box workflows let your lab start collecting data and running reports right away.

Pre-configured & validated

No lengthy implementation cycle, no IQ/OQ/PQ backlog. Once LabWare has your metadata, you can be up and running.

Customer success

Onboard quickly with best-in-class features, training, and support and then upgrade as your business grows and your needs expand.

Configurable platform

When you need more than pre-built workflows, configure the platform to your workflows with more than 250 purpose-built modules.

Data Science Engine

Configure analytics to answer questions without building an in-house analytics team.

Laboratory Instruments

Native interfacing with common biopharma QC instrumentation removes manual transcription.

ERP

Connect to enterprise resource planning (ERP) systems to keep inventory, procurement, and quality data aligned.

MES

With Körber’s PAS-X Manufacturing Execution System (MES) and LIMS integration, sample requests, sample data, and results are exchanged automatically.

SPC

Feed process and quality data into statistical process control (SPC) tools for trending and control charting.

Cloud

Deploy in the cloud or on premises, on the same platform and the same data model either way.

AI Analytics

Configure LabWare’s Data Science Engine to compare bioreactor runs, trend critical quality attributes for continued process verification, and catch drift before it becomes an OOS.

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Laboratory Software for Biopharmaceutical & Biotechnology Labs

Trusted by 21 of the top 25 biopharmaceutical companies in the world