In an interview with BioPharma APAC, Ashok Kumar, Head of BIO4C Commercial at Merck Life Science (Asia Pacific), shares insights on what sets Bio4C™ ProcessPad apart as a comprehensive solution for Continued Process Verification (CPV) in the biopharmaceutical industry. Kumar highlights the unique features and advantages of Bio4C™ ProcessPad, including its embedded database, contextual connections, and real-time monitoring capabilities, which collectively contribute to better data management, analytics, and ultimately, improved therapeutic outcomes.

What distinguishes Bio4C™ ProcessPad as a comprehensive solution for Continued Process Verification (CPV) in the biopharmaceutical industry?

Many traditional software solutions in the market can support Continued Process Verification (CPV) but what differentiates the Bio4C™ ProcessPad is its ability to combine all the tasks into one single platform.

CPV involves extensive data monitoring against defined limits throughout a product's commercial life. Bio4C™ ProcessPad by Merck works as a data visualization, analytics, and process monitoring platform, facilitating the intricate CPV process while also enabling bioprocess lifecycle management, reporting, and investigation. 

Unique features of Bio4C™ ProcessPad that set it apart from other software in the biopharmaceuticals industry are:

Embedded Database: Unlike traditional software that requires external data aggregation, Bio4C™ ProcessPad includes an embedded database to capture and store batch records. All data entered into Bio4C™ ProcessPad is part of an audit trail and is available to the end user on demand.

Reporting and Analysis: Bio4C™ ProcessPad offers automated reports based on CPV monitoring and trend analysis. It detects trend violations, records control limits, and provides revision history, offering insights into evolving process capabilities.

Contextual Connections: Bio4C™ ProcessPad links process steps (unit operations), enabling users to access parameter correlations across operations. Unlike other machine analytics software that focus solely on upstream process data and overlooks important offline data analysis and trends, Bio4C™ ProcessPad offers an easy and comprehensive way to monitor live processes.

Browser-Based: As the only truly browser-based CPV software, Bio4C™ ProcessPad is built using the latest web technologies that ensure ease of collaboration, scalability, and performance. Its user-friendly interface requires minimal training. While other softwares may take months to deploy, Bio4C™ ProcessPad can be implemented at a site within weeks.

Industry-Focused Design: The architecture of Bio4C™ ProcessPad is specifically designed for pharmaceutical and biopharmaceutical organizations, making it easily adaptable for users at all levels. Unlike other softwares that focuses on advanced analytics requiring expert data scientists, Bio4C™ ProcessPad is accessible and usable by individuals with varying levels of expertise.

How does Bio4C™ ProcessPad manage to integrate and centralize data from various sources for better data management and analytics?

Bio4C™ ProcessPad enables biopharmaceutical scientists to gather and manage data from diverse sources such as paper records, spreadsheets, batch records, quality control data, external databases, data historians, and real-time machine data. This data is consolidated within a single software environment offering comprehensive data visualization and analytical tools for easy statistical analysis.

The software facilitates data analytics by generating campaign reports, process summary reports, Annual Product Reviews (APRs), and Annual Product Quality Reviews (APQRs). In addition to offline data monitoring, Bio4CTM ProcessPad-RT collects, aggregates, and provides direct web browser access to real-time streaming data from processing equipment.

In what ways does a structured Continued Process Verification (CPV) program, like the one supported by Bio4C, contribute to maintaining process consistency and control within manufacturing?

CPV is a crucial part of the validation process that ensures product quality. A structured CPV program helps in the process by continuously monitoring the product and maintaining consistency and control in manufacturing.

A CPV program such as that supported by the Bio4C™ ProcessPad can help the manufacturing process by:

Comprehensive Data Integration: It can consolidate data from diverse sources, such as spreadsheets, batch records, quality control data, external databases, etc. ensuring data integrity and completeness throughout the product lifecycle.

Real-Time Monitoring: It collects, integrates, and streams data in real-time from processing equipment, enabling continuous monitoring of critical parameters. This proactive approach facilitates early detection of deviations and ensures process stability.

Reporting and Analysis: It can aid in ongoing process verification by creating automated reports that provide trend analysis and discover violations in trends. It also keeps track of control limitations and provides a revision history, allowing you to see how process capabilities evolve.

Parameter Correlations: Bio4C™ ProcessPad's powerful visualization technology allows users to study parameter correlations across several process phases. This capacity enables in-depth analysis and optimization, leading to increased process efficiency and product quality.

Could you discuss the role of Continued Process Verification (CPV) in ensuring controlled quality processes and the regulatory frameworks that govern its implementation?

Continued Process Verification (CPV) ensures that the validation process remains controlled and consistently produces high-quality products. Unlike the initial stages of process validation- Process Design, and Process Performance Qualification, which have distinct endpoints, CPV is maintained throughout the life of a drug and demands a comprehensive strategy.

Continuity in CPV monitoring ensures controlled quality processes and is executed with five primary steps:

• Establishing clear parameters and criteria for signaling
• Setting the frequency for monitoring and evaluation
• Defining criteria for evaluating signals and determining appropriate actions
• Taking further actions if required
• Recording signals and corresponding responses

The FDA provides regulatory frameworks for implementing CPV, emphasizing specific procedures for data collection and analysis. These regulations stipulate that collected data must verify quality attributes, including intra-batch and inter-batch variations. Statistical trending of the data is necessary to assess process stability and capability. CPV processes should ideally be conducted by individuals with adequate statistical training to ensure accurate data collection and analysis methods. Additionally, there should be a system in place to detect unplanned deviations from the process, continuously evaluate process performance, promptly identify any issues, and implement corrective actions.

How does Bio4C™ ProcessPad contribute to Merck’s new approach to manufacturing that emphasizes accuracy, cost-efficiency, and real-time operational visibility?

Bioprocessing is a complex procedure demanding extensive expertise and comprehension of various factors influencing performance. Bio4C™ ProcessPad streamlines data management and analytics, contributing significantly to Merck’s new approach to manufacturing, which emphasizes accuracy, cost-efficiency, and real-time operational visibility. 

Accuracy

The software ensures the accuracy and reliability of all entered data via a dual-layer verification process. Strict access controls prevent unauthorized data manipulation, while comprehensive audit trails meticulously record every user action. This stringent data management ensures high accuracy in the manufacturing process.

Cost-Efficiency

It combines all the tasks into one single software enabling users to monitor, collect, and analyze data. It identifies process deviations, and generates reports all on one platform, making it one of the most cost-effective options.

Real-Time Operational Visibility

The software offers real-time monitoring and advanced visualization tools, giving insights of the manufacturing process. This proactive approach enables early detection of deviations, ensuring process stability.

What specific functions does the Bio4C software perform within the Merck Life Science operations in India, and how does it align with the industry needs and regulations?

Bio4C ProcessPad™ is designed to collect data, visualise it, and provide analytics for bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV). By intelligently merging process data from various sources, the solution forms a single, integrated data repository that remains updated, comprehensive, and easily accessible throughout the product lifecycle. Bio4C ProcessPad™ provides a robust solution for managing process data across the entire lifecycle.

The Bio4C software aligns with the industry rules and regulations in the following ways:

• The data collected is used to evaluate process stability and capability: The software gathers and integrates offline data and real-time streaming data from processing equipment, enabling continuous monitoring of critical parameters. 
• Data verifies quality attributes: The software provides advanced visualization technologies that give access to parameter correlations across various process steps. This step facilitates in-depth analysis and optimization efforts for enhanced process efficiency and product quality.
• People with adequate statistical training develop the data collection plans and methods for analysis: Bio4C™ ProcessPad simplifies reporting and analyses by offering templates for campaign reports, process summaries, and regulatory reviews allowing people with different levels of expertise to develop accurate and uniform data collection plans and methods of analysis.

With the advent of new technologies in bioprocessing, what are the next steps for Bio4C in terms of innovation and meeting the evolving demands of the pharmaceutical industry?

Merck continuously works to improve people’s lives by developing high-quality treatments, and staying ahead of the curve through innovative software technologies that will assist industry players embrace the future of bioprocessing.

As a next step, Merck is preparing for the launch of Bio4C ProcessPad™ software version 4.4, which will introduce a holistic solution for managing Annual Product Quality Reviews, covering the entire process from creation to archiving. Additionally, this version will feature an advanced campaign report to enhance Continued Process Verification reporting.

Through our BioContinuum Platform and Bio4C ProcessPad™, Merck aspires to support the industry in realizing the facility of the future. 

Other steps Merck is focusing on in terms of innovation for Bio4C are:

• Advanced reporting capabilities
• Predictive and Prescriptive Analytics
• Process optimization
• Feedback control
• Autonomous operations
• Natural language processing to support search
• Data retraval and reporting, along with the application of AI/ML for predictive maintenance of systems.