Build Real-Time Intelligence with Predictive Analytics, PAT Automation and AI in Life Sciences

Pharma Value Drivers

Driving Pharma Efficiency with Digital Intelligence

Deliver rapid scale-up, predictive quality analytics, and 21 CFR Part 11 data integrity

  • Connect real-time product, process, and equipment data for pharma manufacturing analytics

  • Implement digital manufacturing production process development to scale new molecules faster and smarter

  • Maintain 21 CFR Part 11 data integrity and compliance, with real-time release

  • Use anomaly detection and predictive monitoring to improve asset reliability management

Pharma Operations Challenges

Critical Challenges in Pharma Operations

Siloed process and product data systems

Legacy tools limit visibility into batch context and slow decision-making with analytics in pharma manufacturing

Lack of predictive insights into batch variability

Inability to detect early shifts with CPV in pharmaceutical manufacturing slows down product release.

Under-utilization of PAT investments for quality and process yield improvement.

Manual spectral data analysis without PAT automation increases cycle time and prevents real-time release readiness.

Tech transfer and scale-up delays with manual processes

Inefficient scale-up of manufacturing production process development slows down time-to-market and reduces profitability.

ai in pharma 4.0​

Reactive maintenance and unplanned downtime

Route-based inspections and legacy condition-based maintenance fail to monitor hidden risk of failure and require too much manual analysis effort.

Struggling with inconsistent quality and yield?

Explore how AI in pharma manufacturing unlocks improvement in process intelligence, yield, and quality.

Applications

Targeted Pharma Applications

Product Performance Improvement
Quality
By Design
Batch
Optimization
Predictive quality analytics Predictive
Maintenance
Bioprocess analytical monitoring

Improved Vaccine Purity

Used in-silico model optimization to increase vaccine purity & enhance product recovery

+11% purity

Purification Yield Optimization

Improved Yield in Chromatography

Used golden batch modeling to increase batch yield and minimize degraded output.

+10% capacity

digital twin in pharma manufacturing

The business value of Industrial Customer Success Stories

AI-Driven Process Development

Accelerated batch design using ML-based DoE for faster bioprocess analytical monitoring.

-75% DoE time

Intelligent automation and low-code​

AI-Optimized Fermentation Boosts Protein Yield

Enhanced product yield through AI -driven models in real-time

+10% yield improvement

digital twin in pharma manufacturing

The business value of Industrial Customer Success Stories

Purification Yield Optimization

Higher Yield in Biopharma Batches

Enabled batch process optimization using AI-based pattern detection.

+20% batch yield

Optimized Freeze Drying Batches

Shortened drying cycle time while maintaining product quality, improving batch throughput.

-15% cycle time

digital twin in pharma manufacturing

The business value of Industrial Customer Success Stories

Downtime Reduction with AI

Enabled predictive alerts for asset reliability management and maintenance optimization.

Reduce unplanned downtime in manufacturing

Reliability Insights for Fermentation Asset

Early warnings reduced unplanned shutdowns with batch prediction ML models.

-60% unplanned stops

digital twin in pharma manufacturing

The business value of Industrial Customer Success Stories

With Quartic’s AI-based CPV and PAT automation, we reduced release review time by 40% while increasing yield.

Director of Manufacturing Sciences Global Biologics Firm

Core Capabilities

Advanced Capabilities for Pharma & Biotech Efficiency

Process
Development
Pilot
Plant
Tech
Transfer
Operations &
QA
Process & Quality Optimization
Manufacturing production process development

Process Design & Characterization

  • Integrated digital workspace for managing process design and experiment
  • DoE in real time using a combination of process and PAT data streams
  • Utilize previous experiments data to expedite the molecule development
  • Use empirical and mechanistic models to improve wet experiments
21 cfr part 11 data integrity​

Knowledge Management for Development

  • Easily connect experiment results to product quality submissions
  • Utilize past characterizations to support future scale-up projects
  • Gather clinical and regulatory data for QbD documentation
  • Use development history to create models that support CMC submissions
Tech transfer in pharma industry​

Tech Transfer with Digital Twin

  • Develop and refine digital twins during the phases of design and qualification
  • Encourage tech transfer in pharma industry by maintaining an ongoing flow of knowledge
  • Capture pre-qualification learnings for commercial operations
  • Enable faster validation cycles and scale-up
Digital twin in manufacturing

Unified Knowledge Management

  • Centralize product control strategy and compliance workflows
  • Integrate QC, lab, and process data using digital twin software
  • Enable no-code pipelines for ML and AI use cases
  • Support real-time release and exception-based batch review
Process & Quality Optimization

Optimization, ILM & Real-Time Release

  • Use AI-driven CPV and PAT automation to forecast CPPs and CQAs
  • Improve process yield and reduce batch rejections
  • Implement real-time release to accelerate batch disposition
  • Lower cost of quality with closed-loop intelligence
Resources

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