Software for CMC Product Development

Enterprise Software for CMC Information Management of Process Schemes, Impurity Data, Batch Histories, and More

Luminata® is a Chemistry, Manufacturing, and Controls (CMC) development decision support tool. It enables product development teams to make the right call the first time by integrating all project materials; it translates data into information and then knowledge.

Implement a single organizational source for process scheme, impurity control, formulation development, drug stability, and batch genealogy information
Utilize a vendor-neutral, multi-technique platform to assemble all process, chemical, and analytical data according to Quality by Design (QbD) regulatory requirements

Import LC/UV/MS data and chemical structures to compile complete route schema for multi-stage reaction processes
Design QbD-compliant impurity control strategies that quantify fate and purge by automatically calculating carryover between stages
Create degradation maps for stress testing studies that are color-coded according to reaction conditions and include kinetic plots

Easily create a process map with corresponding analytical data for each entity

Import LC/UV/MS data to automatically populate color-coded process map entries (blue—starting materials, green—intermediates)

Route & Product Development Features

Employ Luminata to consolidate all critical product development information in one location, pairing requisite analytical data with route schema to ensure a complete understanding of multi-stage reaction processes.

Design a comprehensive process map by importing LC/UV/MS datasets to drive creation of new entries, or select existing compounds from the onboard reference dictionary
Automatically categorize entries in the process scheme as Starting Materials, Intermediates, API(s), Impurities, Degradants, Solvents, or Reagents
Autopopulate output tables by linking any type of attribute map (process, formulation, stability, etc.) with corresponding analytical data
Capture process schema evolution to inform new lots, batches, and process map versions while also justifying new strategies for route optimization
Collaborate with colleagues across development in real-time via shared access to a central database housing all route development information

Impurity Control Features

Use Luminata to establish effective process and analytical impurity control strategies based on live spectral data and route knowledge, in a purpose-built environment.

Link interpreted analytical data with chemical structures to automatically assemble error-free impurity maps
Track process variation between different lots and batches, and compare impurity profiles across stages
Auto-calculate carryover of impurities throughout a given synthetic route directly from LC/UV/MS data:

Quantify fate and purge
Set detection and quantitation limits for a given stage
Compare spike impurity studies for multiple batches

Create formatted impurity profile and control strategy tables (lot-to-lot by stage)
Ensure compliance with regulatory submission requirements through a QbD approach to impurity management, including single-click reporting capabilities

Luminata Overview Movie: Software for the efficient and comprehensive management of impurity data

Learn how Luminata can greatly reduce organizational time spent on impurity control strategies!

Automatically calculate carryover of impurities between stages, as well as cumulative carryover across all stages

Assemble a degradation map and kinetic plot that capture stress test results, including corresponding LC/UV/MS data

Easily add theoretical degradants to a degradation map that already contains observed degradants

Drug Product & Drug Substance Stability Features

Employ Luminata to intuitively represent API forced degradation schemes under various conditions. Easily assemble degradation maps (with structure color-coding to visualize corresponding stress conditions and degradation products), associated spectroscopic characterization data, and kinetic plots.

Import and batch process forced degradation LC/MS datasets containing records across different time points
Automatically process time point datasets to create a forced degradant map and kinetic plot(s) that capture all forced degradant information in one location
Specify a known degradant list to search for target impurities across all forced degradation experiments (ex. 7 d, 14 d, 28 d, etc.)
Add theoretical degradants to the process scheme (ex. through import of a *.sdf file) and store them with observed degradants
Streamline data comparison between stability studies by quickly overlaying chromatograms from multiple sequences

Formulation Development Features

Following synthetic route optimization, apply Luminata to manage formulation development. Accelerate the transition from drug substance to drug product production by integrating analytical and process data in a single knowledgebase.

Develop design protocols based on the chemistry of the API / Drug Product formulation
Design an integrated formulation map to track all stages in drug product synthesis
Perform drug-excipient comparability studies and test trial formulations
Append micrograph images to the Batch History Table to visually track the composition of batches during crystallization experiments

Construct a detailed formulation map for stepwise tracking of drug product manufacture

Visually track the composition of crystallization results by appending images to the Batch History Table during formulation development

Track each batch for a given process by creating a complete family tree, with associated analytical data for each batch

Quantify variation across batches through the autogenerated Batch Control chart

Batch Genealogy Features

Use the Batch Genealogy functionality in Luminata to track each batch created for a given process, and easily attach corresponding batch analytical data (chromatograms, mass spectra, etc.) to view any quantitative impurity tracking trends.

Create a comprehensive family tree of every batch for a given process, and track batches numerically through the associated Batch Impurities Table
Overlay all chromatograms from a particular stage across batches to contrast data visually, plus choose to designate a reference chromatogram for further comparisons
Search across a project to determine the presence of a target compound in all batches, via automatic links created from the reference database when adding entries to the process scheme
Store input (I/P) and output (O/P) values for each batch, for example to assist with manufacturing oversight
Register and integrate all batches created internally or externally (ex. CRO), reducing transcription errors that result from multiple individuals working on the same batch genealogy project

Resources

Movie
Analytical Workflow

See how Luminata allows you to easily attach live LC/MS datasets to a process scheme and manage analytical data like never before. 2.0min
Play

Movie
Create a Process Scheme

See how easy it is to import a synthetic scheme into Luminata. 1.0min
Play

Movie
Build a Process Map

See how Luminata makes the management of chemical information simple through the creation of a full process map. 3.5min
Play

Movie
Web Portal

Learn how the online version of Luminata can improve organizational collaboration via its browser-agnostic web portal interface. Employ all key desktop version functionalities: import data, assemble process maps, track impurities, etc. 3.0min
Play

Movie
Web Portal—Batch Genealogy

Learn how the Luminata web portal can be used to visualize a batch family tree for all process development batches by compiling batch fates. Plus, watch how associated analytical data is paired directly with all batches compiled in the family tree. 2.0min
Play

Movie
Luminata Overview

Luminata—Cut your impurity data time investment from months into minutes
Play

Webinar
Reduce your Time Investment in Impurity Data Management

Learn how Luminata allows you to centralize and assemble all your analytical and chemical process information in one informatics platform, reducing tedious, time-consuming data transcription. Also how to collaborate effortlessly with team members, track impurities in real-time, and search and access impurity data more easily to establish effective controls faster.
Watch on Demand

Whitepaper
Modern Informatics Technologies that Enable Pharmaceutical Stress Testing

Read a new whitepaper that describes the significant advances in pharmaceutical stress testing over the past 20 years, largely through the development of several novel analytical and automation tools, like ACD/Labs Luminata.
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AppNote
Tracking Fate and Purge of Impurities and Calculating Carryover

Learn how Luminata supports effective workflow optimization for process chemists, and enables informed decision-making by automatically calculating quantitative purge factors for process-related impurities using associated analytical data.
Read more

Ready to learn more?

Contact us to request a demonstration of our software, or to answer any questions you may have.

Comprehensive Decision Support Software to Accelerate CMC Product Development