Improve decision making and maximize profitability at each lifecycle phase

We help companies transition from document- to data-centric materials and process knowledge management, establishing seamless information flow from lab to plant.

Pharma and biotech companies are under an increased pressure to deliver more personalized therapies while managing global, extended value chains, growing regulatory burdens and increased manufacturing process complexity. As the industry adopts pharma 4.0 strategies to address the challenges, ensuring data availability and integrity across the value chain is critical.

Traditional document-centric knowledge management and functional silos slow down regulatory approvals, technology transfers and scale up preventing companies from capitalizing on pharma 4.0 and meeting market demands.

When materials and process knowledge are established digitally during discovery and development, they can more easily and quickly be evolved and enriched throughout the product lifecycle as the process moves across functional stakeholders, systems and sites, both internal and external. A digital data-centric product and process definition enables a digital twin with virtual simulation capabilities and enhances knowledge sharing, improving operational flexibility, increasing efficiencies and fostering innovation.

What is Pharma 4.0?

Pharma 4.0 is an operating model developed by the International Society for Pharmaceutical Engineers (ISPE) to adapt Industry 4.0 strategies, also called Smart Factory, to the unique requirements of the pharma industry. It aims at enabling organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

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Pharma 4.0 is an operating model developed by the International Society for Pharmaceutical Engineers (ISPE) to adapt Industry 4.0 strategies, also called Smart Factory, to the unique requirements of the pharma industry. It aims at enabling organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

Pharma 4.0 is an operating model developed by the International Society for Pharmaceutical Engineers (ISPE) to adapt Industry 4.0 strategies, also called Smart Factory, to the unique requirements of the pharma industry. It aims at enabling organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

Real Results

CASE STUDY
We helped a leading biologics company enable rapid molecule development and scale their portfolio by over 300% with greater compliance.

Evolving to digital knowledge management delivers significant strategic, operational and financial benefits.

Accelerated Innovation

  • Improved breakthrough drug rates
  • Improved rate of new molecular candidates advancing from lead optimization into development pipeline by 20%
  • Improved ROI on portfolio by 1.5%

Increased Revenues

  • Reduced development cycle times by 30%
  • Reduced times for creation and tracking of product data per country by 18%
  • Improved regulatory compliance and decreased audit failures by 50%

Increased Profitability

  • 50% reduction in packaging/labeling errors
  • Improved quality and compliance cycle times by 35%
  • Reduced cost of compliance and quality audits by 20%

Reduced Invested Capital

  • Decreased late cycle capital equipment procurement needs by 10%
  • Decreased cost of reworked tooling by 25%
  • Increased return on capital invested by 3%

Digital Knowledge Management (DKM)

Digital Knowledge Management is an enterprise solution approach that digitally captures the ISA-88 data structure representing the pharma manufacturing process and materials and manages them under change control.

It connects various sources of data, organizes, standardizes and streamlines the information required to define the product requirements, materials, and the way it is manufactured and packaged. This includes its physical and chemical specifications, critical quality attributes, process parameters and setpoints, manufacturing requirements, work instructions and the management of variability in those data sets from line to line and plant to plant.

DKM enables the creation and management of general recipes and variations of the drug product for manufacturing at different factories and for multiple market authorization requirements. The variation definitions provide robust traceability back to the general recipe and when combined with as-produced electronic batch records (EBRs) enable advanced analytics across the product portfolio, enhancing drug development, commercialization, technology transfer and speed to market.

Key Use Cases

  • Product Record and Change Management
  • Risk Assessment and Management
  • Structured Electronic Drug Development Record
  • Process Control Development (General, Site and Variation Recipes)
  • Packaging, Artwork and Labeling Management
  • Integrated Configuration Management II (CMII)
  • Quality and Risk Management
  • Global Regulatory Information Management
  • Drug Development Portfolio Management
  • Technology Transfer and Scale-Up
  • Materials and Capabilities Sourcing
  • Supplier Quality Management and Score-Carding

How We Help Companies Enable Digital Knowledge Management

We offer end-to-end services from strategy to technology implementation and organizational change management.

Maturity Assessment & Benchmark

Strategy & Roadmap Development

Technology Assessment & Fit Gap Analysis

Process Design & Reengineering

System Architecture, Design, Development & Configuration

System Extensions & Integrations

Natural Language Processing (NLP)-based Document Conversion

Intelligent Data Migration, Testing, Validation & Deployment

User Adoption, Organizational Leadership & Change Management

Product Lifecycle Intelligence & Analytics

Installations or Cloud Provisioning

Application Management, Support & Hosting

Technology Partners

CASE STUDY

We helped a leading biologics company enable rapid molecule development and scale their portfolio by over 300% with greater compliance.

Our client’s goal was to reduce time to market and cost by using contract development and manufacturing organizations (CDMOs) to accelerate the process of getting new drug substances ready for clinical trials and commercialization.

However, all their materials and process development data for how the product should be produced was in paper-based documents and across siloed systems, making it resource intensive and time-consuming to collaborate with external organizations. They realized that without the ability to transfer requirements and critical recipe data effectively, they would not be able to achieve the targeted time and cost benefits from the use of CDMOs.

By implementing a digital knowledge management solution, our client was able to create a unified repository for materials, recipes, variations, market requirements by region and clear traceability to previous recipes and process models, reducing development cycles and improving collaboration with extended manufacturing networks.

Our work made it possible to increase speed to trial and patent approval by enhancing technology transfer as a result of structured digital knowledge creation and management.

CASE STUDY

We helped a leading pharma company define their global strategy for digital knowledge management.

We were engaged to define the company’s global strategic roadmap for digitizing the drug product development and manufacturing processes across facilities globally. Digital knowledge management enabled the creation of packaging configurations and variation use instructions for different markets.

By working in partnership with internal teams, we developed common information model for both materials and processes that could be used across the enterprise. That common information model extended into an enterprise solution architecture that considered how data was created, managed, enriched and accessed by each team, resulting in centralized knowledge management, organizational alignment and improved handoff.

Our holistic approach to digital knowledge management enabled packaging configurations that support the variations necessary for each market, powering fast reconfiguration of packaging lines and speeding cycle times.

To further help our client drive the initiative forward, we developed a clear value case for digital technology transfer and an actionable roadmap for continued focus.

Our work helped ensure successful implementation of a digital knowledge management solution and accelerated time to benefit realization.

Thought Leaders

Sachin Misra 2014
Principal & Global Leader - Pharmaceutical, Biotechnology and CDMO Practice