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Comprehensive Decision Support Software to Accelerate CMC Product Development

Enterprise Software for CMC Information Management

Luminata® is Chemistry, Manufacturing, and Controls (CMC) product development software. This decision-support tool enables product development teams make the right call the first time with up-to-date, comprehensive, project-related information at their fingertips.

Automatically calculate carryover, fate, and purge of impurities between stages - quantify fate and purge; set detection and quantitation limits; compare spike impurity studies across batches
Import LC/UV/MS data and chemical structures to compile complete route schema for multi-stage reaction processes

Collaboration and CMC Decision-Support Software for Process Development Teams

Collaborate easily with a software application that assembles and connects process, chemical, and analytical data in one interface.

Efficient route development, impurity mapping, and batch tracking for process chemists and manufacturing groups with visual process maps and connected analytical data.

Up-to-date route information for analytical chemists and the ability to easily manage all analytical data including impurity fate & purge, and stability studies.

Effective control strategy development, facile assessment of batch analytical data throughout the supply chain, and assembled data to facilitate efficient regulatory filings for project team leads.

Click below to learn how Luminata supports product development for each of the following areas of study.

Route Scouting & Process Development Mapping

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.

  • Create a comprehensive process map for your project including starting materials, intermediates, impurities, and API
    Create a comprehensive process map for your project including starting materials, intermediates, impurities, and API
  • Chromatographic data for step 1 of an API synthesis is graphed to view consistency of the product and impurity trends
    Chromatographic data for step 1 of an API synthesis is graphed to view consistency of the product and impurity trends
  • 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
  • Undertake dynamic risk assessment through convenient visualization and graphing of analytical data and reaction parameters in the same interface

Impurity Tracking, Fate and Purge, and Control

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 impurity maps
  • Track process variation between different lots and batches, and compare impurity profiles across stages
  • Auto-calculate carryover of impurities directly from LC/UV/MS data
  • 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!

Drug Product & Drug Substance Stability Data Management

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.

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

Manage Formulation Development

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

Supply Chain Management

Supply chain management in Luminata is delivered through the Batch Genealogy functionality. Track each batch created for a given process, and easily attach corresponding batch analytical data (chromatograms, mass spectra, etc.) for batch-to-batch assessments and real-time decision-making.

Track each batch for a given process by creating a complete family tree, with associated analytical data for each batch
Track each batch for a given process by creating a complete family tree, with associated analytical data for each batch
  • 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
  • Register and integrate all batches created internally and/or externally (e.g. by a CMO/CDMO), for a full understanding of your supply chain landscape

Resources

In this webinar we discuss how you can manage all your theoretical and observed degradants, experimental conditions, and analytical results (including LC/MS data and structural information) using our software solution, Luminata®.
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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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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.
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In the first webinar of this two-part series we will focus on how impurity data management software (Luminata) supports the process chemist's workflow.
Watch on Demand

In the second webinar of this two-part series we will focus on how impurity data management software (Luminata) supports the analytical chemist's workflow.
Watch on Demand

Joe DiMartino spoke with Pharmaceutical Technology about the impact COVID-19 is having on the pharmaceutical supply chain and how companies can prepare for these challenges.
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