Improve decision making and maximize profitability at each lifecycle phase

We help companies transition from document- to data-centric materials and process 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 and growing regulatory burdens. 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 data 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 definitions are established digitally during discovery and development, they can more easily and quickly be evolved throughout the product lifecycle as the process moves across stakeholders, systems and sites, both internal and external. A data-centric product and process definition enables 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

  • Reduced development cycle times by 30%
  • Reduced times for creation and tracking of product data per country by 18%
  • Improved rate of new chemical entity candidates into development portfolio by 20%

Increased Revenues

  • Improved resource efficiency by 25%
  • Improved Regulatory compliance and decreased audit failures by 50%
  • Reduced change cycle times by more than 30 days

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

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

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

Digital Knowledge Management allows for a general recipe to accommodate variations of the same active pharmaceutical ingredient (API) for manufacturing within different factories. The variations provide robust traceability back to the general recipe and enable valuable analytics across the product portfolio, enhancing technology transfer and speed to market.

Key Use Cases

  • Product Record 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

How We Help Clients 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 get new substances ready for clinical trial and commercialization using contract development and manufacturing organizations (CDMOs) to reduce time to market and cost.

However, all their materials and process 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 formulation data effectively, they would not be able to gain 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 recipes, variations, market requirements by region and clear traceability to previous patents, 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 pharmaceutical company define their global strategy for digital knowledge management.

We were engaged to define the company’s global strategic roadmap for digitizing the drug manufacturing process across facilities globally. Digital knowledge management enabled the creation of packaging configurations and variations for different markets.

By working in partnership with internal teams, we developed recurrent data requirements for both materials and processes that could be used to create a common data model. That common data model extended into a solution architecture that considered how data was used 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