Consolidate all your process development information in one location. Connect analytical data with route schema to ensure a complete understanding of multi-stage process routes.
- Build comprehensive maps for your evolving process
- Link analytical data to each chemical in your scheme
- Create process maps by importing LC/UV/MS datasets or select existing compounds from the reference dictionary
- Categorize entries in the process scheme as Starting Materials, Intermediates, APIs, Impurities, Degradants, Solvents, or Reagents
- Auto-populate output tables by linking attribute maps (process, formulation, stability, etc.) with analytical data
Establish effective process and analytical impurity control strategies based on live spectral data and route knowledge, in an environment built for Quality by Design (QbD) in pharmaceutical drug development.
- Use an impurity map to automatically track fate and purge data
- Auto-calculate impurity carryover from analytical results
- Access data from in-process control experiments during scale-up
- Build control strategies using the filters and searching functionality of impurity master mode
- Avoid errors and save time using built-in reporting tools
Assemble degradation maps that cover complete drug substance and drug product forced degradation studies.
- Import and process forced degradation HPLC and MS datasets
- Make formulation decisions based on kinetic plots automatically created from analytical data
- Search for impurities by structure across forced degradation experiments
- Automatically process time-point datasets to create forced degradant maps and kinetic plots
- Add theoretical degradants to the process scheme (e.g., through import of a *.sdf file) and store them with observed degradants
Luminata’s drug formulation tools accelerate the transition from drug substance to drug product by integrating analytical and process data in one place.
- Perform drug-excipient comparability studies, test formulations, and excipient case studies
- Use accelerated stability simulation tools to predict degradant formation
- Ability to add elemental impurity meta data
- Include data from formulation studies such as dissolution rates
- Build comprehensive formulation maps
- Append micrograph images to visually track the composition of batches during crystallization experiments
Use Luminata’s supply chain data management tools to attach analytical data to each batch for real-time decision-making and batch genealogy tracking.
- Create a comprehensive family tree of every batch
- Identify irregularities by comparing analytical data to a reference batch
- Use structure search to quickly find where an impurity or entity appears within the supply chain
- Do batch-to-batch comparison with analytical data
- Register and integrate all batches created internally and externally
- Create a custom report per project and/or supply chain record
Luminata is built on the Spectrus platform, allowing you to import, process, and store your analytical data.
- A single standardized and harmonized data format for the analytical techniques used to characterize compounds and formulations in your labs. LC/MS, GC/MS, NMR, Chromatography, Raman, IR, UV, Visible, and more
- Native support for >150 data formats including major instrument vendors, open-source formats, and emerging standards (e.g., AnIML, JCAMP, and ADF from Allotrope)
- Luminata will detect the type of data you’re importing and offer tools for processing and analysis
- Export your data in machine-readable formats (e.g. JSON) that are ready for data science and artificial intelligence applications
- Connect and assign full chemical and biochemical structures, structure fragments, Markush structures, or atoms to spectra and chromatograms
Route Scouting & Process Development 
Impurity Control 
Stability and Forced Degradation 
Formulation Development 
Supply Chain Analytical Data Management 
Data Import, Export, and Analysis 
