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
- Integrate Quality by Design (QbD) principles in route selection
- Design a process map by importing LC/UV/MS datasets to drive creation of new entries, or select existing compounds from the onboard reference dictionary
- Categorize entries in the process scheme as Starting Materials, Intermediates, API(s), Impurities, Degradants, Solvents, or Reagents
- Auto-populate output tables by linking any type of attribute map (process, formulation, stability, etc.) with corresponding 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
- Develop robust controls based on all the relevant data in one place
- Implement in-process control experiments for scalability
- Build control strategies through the impurity master mode functionality
- Perform fate & purge, and spiked impurity calculations
Assemble degradation maps that cover complete drug substance and drug product forced degradation studies.
- Import and process forced degradation HPLC and MS datasets for a complete study map
- Make formulation decisions based on kinetic plots automatically created from analytical data
- Search for target impurities across forced degradation experiments
- Automatically process time-point datasets to create a forced degradant map and kinetic plot(s) that capture all forced degradant information in one location
- 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.
- Develop design protocols based on the chemistry of the API/Drug Product formulation
- Build comprehensive formulation maps
- Perform drug-excipient comparability studies and test formulations
- Perform excipient case studies for preformulation studies
- 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 for a complete supply chain map
- Identify irregularities by comparing analytical data to a reference
- Use structure search to quickly determine the presence of an impurity/entity in all batches
- 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 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 to process and analyze it
- Connect and assign full chemical and biochemical structures, structure fragments, Markush structures, or atoms to spectra and chromatograms
Route Scouting & Process Development 
Impurity Control 
Drug Substance & Drug Product Stability 
Formulation Development 
Supply Chain Analytical Data Management 
Data Import and Analysis 
