Life Sciences

Small Molecule • Bioprocessing • Cell & Gene • Bio Similars • Medical Devices

Product Development • Tech Transfer • Manufacturing • Quality • Reliability

GxP and CFR21 Part 11 Compliant Platform, Applications

and end to end practical solutions that accelerate your journey to Pharma 4.0

Ready to Deploy Applications

Process Development

Increase Process Development performance

Digitalized PD

Create and capture process development knowledge to increase PD performance, accelerate tech. transfer and scale up. Manage design space in real-time with process and quality data.

QbD-based Process Development

QbD-based Process Development

Capture PD knowledge to model and establish the CMC control strategy to create a foundation for CPV.

Batch MVDA

Improve Batch Performance

Batch Analytics / MSPC

Continuously improve batch performance and outcomes using a multi-variate golden batch profile.

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Predictive Product Performance Reduced Batch and Equipment Degradation

Predictive Product Performance

Visibility into real-time batch performance, variables influencing poor batch performance, and data trends of key variables causing batch and equipment performance degradation.

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Process Optimization

Yield & Step-Loss Optimization for increased consistency

Yield & Step-Loss Optimization

Objective and constraint-based optimization within the operation space to increase average yield, reduce loss between units, and improve consistency.

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Optimize any KPI or CQAs with Batch and Process Optimization

Batch and Process Optimization

Objective and constraint-based optimization within the operation space to optimize any KPI or CQAs.

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Automated PAT analysis and Automation

PAT Automation

Automated PAT analysis to implement in-line monitoring, minimize transition times between unit operations, support real-time release and enable closed-loop control.

Quality Monitoring & Prediction (CPV)

Abnormal Event Prediction for Proactive Insights and Predictions

Abnormal Event Prediction

Turn alarm and failure history into proactive insights and predictions to make downstream equipment more responsive to process deviations.

Implement Real-Time Evidence Based CAPA Management

Non-conformance Monitoring

Identify deviation trends for intelligent QMS by discovering underlying patterns using ML. Support and implement real-time evidence based CAPA management.

Prediction of Intermediate and Final CQAs

Predictive Quality

Prediction of intermediate and final CQAs, enabling corrective actions and expedited, evidence-based batch reviews.

Reliability

intelligent Asset Performance Monitoring

intelligent Asset Performance Monitoring
(iAPM)

Baseline health for multi-product/recipe assets and unit operations equipment. Continuous risk monitoring of critical failure modes and early detection of process induced faults. Real-time root cause detection with severity rating.

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Risk-Based Asset Health Management and Predictive Maintenance with RCM

Reliability Centered Maintenance
(RCM)

End-to-end digital workflow for RCM using machine learning for risk-based asset health management and predictive maintenance.

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Capabilities for an Agile and Resilient Supply Chain

Manufacturing Process Design and Characterization

Process Design & Characterization

  • Integrated digital environment for knowledge capture, design, and experimentation
  • Combine PAT and process data streams for real-time DOE projects
  • Accelerate molecule development by leveraging prior experiment results
  • Augment wet experiments with in-silico models – both mechanistic and empirical models
Manufacturing Knowledge Management

Knowledge Management

  • Link experiment results to product and quality submissions
  • Leverage knowledge and characterization of past projects to aid in development and scale up of new, similar projects.
  • Capture clinical run data up to and including Regulatory Approval Submissions.
  • Use development and clinical data as part of the robustness of the product and process design history to support CMC submissions (Collecting data, building models foundation of QbD)
Model and Optimize the Manufacturing Process with Tech Transfer

Tech Transfer

  • Create and feed the “Digital Twin” through the design, build, qualify stages, then model and optimize using it as part of manufacturing process.
  • Coordinate and share experiences to and from DOEs and to PHAs, Tox, ADME, and MSAT Teams.
  • Capture any pre-qualification state failures or boundary conditions learnings to translate into the PQ or PV and commercial operations
Manufacturing Process Qualification

Process Qualification

  • Capture product profile and performance during engineering and consistency runs
  • Limit testing CPPs and their impact on CQAs with process equipment
  • Optimizing control strategy for CPPs
  • Using PAT to design and analyze inline measurements
Product Lifecycle Knowledge Management

Knowledge Management

  • Define and capture control strategy changes through the product’s lifecycle
  • Integrated environment for QC/Lab/Process data
  • Operation and Product context for QC/Process/IoT data
  • No-dev data pipeline and preparation for ML and informatics
  • Accelerated Tech Transfers
  • Uniform and globalized PLM
Batch and Product Quality By Design

Quality by Design

  • Foundation CPV - Predictive monitoring of CPPs and CQAs
  • Automated DoE for batch/continuous processes
  • Faster DoE experiments and results with ML
  • Real-time batch and product analysis results in less FTE hours
  • Robustness Product Portfolio
  • Reduction in rejects and waste materials/batches
Manufacturing Process Optimization and ILM

Process Optimization and ILM

  • Transfer data/models from previous development stages
  • Operation and Product context for PAT data modelling
  • Real-time soft sensors from PAT data
  • Reliability Centered Maintenance
  • Faster scale up and expansion
  • Consistent yield and quality
  • Increase equipment uptime and safety
Increase Time to Market and Reduce Waste

Review by Exception/Real-Time Release

  • Faster batch disposition – product time to market
  • Reduced investigation hours of spec limit violation – Quality function
  • Reduced cost of compliance – automated evidence-based compliance reviews.
  • Closed-loop control with PAT sources
  • Lower cost of Quality

Introducing MDS (Manufacturing Design Studio) from ZS powered by Quartic

A Complete Life Sciences Supply Chain Solution for R&D, Planning, Development, Engineering, Manufacturing, and Quality

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