The pharmaceutical and biotech industries operate under immense pressure to deliver safe, effective therapies while adhering to stringent quality and regulatory standards. Chemistry, Manufacturing, and Controls (CMC) processes are fundamental to this mission, encompassing everything from drug substance development to final product packaging. Each stage requires meticulous documentation, rigorous data analysis, and strict adherence to evolving regulatory guidelines.

However, the sheer volume of information involved and the critical need for accuracy can make CMC a significant challenge. Traditional methods—reliant on manual processes, siloed systems, and outdated technologies—can lead to costly errors, delays, and missed opportunities for innovation. These bottlenecks hinder efficiency, increase costs, and slow down the delivery of life-saving treatments to patients.

The industry demands a more efficient, data-driven approach to overcome these challenges and open doors for new opportunities for innovation.

Connect™ CMC: A Revolutionary AI-Powered Platform

A Comprehensive AI-Powered Solution

Connect™ CMC is Mareana’s flagship AI-powered platform designed to streamline and optimize the entire CMC life cycle, from early development to commercial manufacturing. It acts as a centralized hub for all CMC-related activities, fostering collaboration and driving efficiency across the organization. 

The platform’s intuitive interface and comprehensive features make it easy for users to manage complex CMC data, documents, and workflows, ultimately reducing the risk of errors and delays. Its AI-powered capabilities provide actionable insights that can help pharmaceutical companies make better decisions faster.

Automated Data Extraction from Paper Batch Records

Connect™ CMC transforms data extraction from paper batch records, eliminating the tedious and error-prone process of manual data entry. By leveraging advanced AI algorithms, Connect™ CMC automatically extracts critical CMC information from paper batch records, ensuring accuracy, consistency, and completeness throughout the entire CMC life cycle. This automation not only saves valuable time and resources but also empowers data-driven decision-making, enabling pharmaceutical companies to focus on strategic initiatives and accelerate drug development.

Intelligent Data Analysis for Informed Decision-Making

Connect™ CMC goes beyond simple data collection and storage. It employs cutting-edge AI algorithms to analyze vast amounts of CMC data, identifying trends, patterns, and anomalies that may not be immediately apparent. These insights enable proactive decision-making, risk mitigation, and process optimization, ultimately leading to improved product quality and faster time-to-market. By harnessing the power of data analytics, Connect™ CMC empowers pharmaceutical companies to make informed decisions that drive innovation and success.

Streamlined Regulatory Submission Support

The complex regulatory process is a critical aspect of CMC, and Connect™ CMC simplifies it. It intelligently extracts relevant data from paper batch records and streamlines the creation of essential documents and reports required for regulatory submissions. This ensures compliance with industry standards and regulations, minimizing the risk of errors and delays commonly associated with manual processes. By automating these tasks, Connect™ CMC accelerates the regulatory approval process, enabling companies to bring their products to market faster.

Enhanced Collaboration and Optimized Workflows

Connect™ CMC fosters a collaborative environment by providing a centralized platform for cross-functional teams to share data, communicate, and manage workflows. This eliminates silos and enhances transparency, leading to improved productivity and faster decision-making. 

The platform’s intuitive interface and customizable workflows make it easy for teams to collaborate effectively, regardless of their location or role, fostering a culture of innovation and continuous improvement.

Why Mareana’s Connect™ CMC Stands Out from Other Top Digital CMC Solutions

Comprehensive AI Power

While Biovia Discoverant focuses on robust data contextualization, Connect™ CMC is an all-in-one AI-powered platform that tackles the entire CMC life cycle, from early development to commercial manufacturing. By seamlessly integrating data from diverse sources such as lab notebooks, analytical instruments, and manufacturing systems, Connect™ CMC provides a holistic view of the entire process. This comprehensive approach ensures seamless integration and optimization of all CMC-related activities, empowering organizations to achieve greater efficiency and productivity.

Unparalleled End-to-End Traceability

Unlike Skyland PIMS, which primarily focuses on creating a contextualized data backbone, Connect™ CMC™ goes further by providing unparalleled end-to-end visibility into the manufacturing process. It achieves this by consolidating data from diverse sources, including lab notebooks, analytical instruments, and manufacturing systems. Leveraging AI-powered genealogy mapping, the platform meticulously tracks every step—from raw materials to finished products—ensuring product quality, identifying potential issues, and meeting regulatory requirements with ease.

Seamless Integration with Existing Systems

While PharmaMV focuses on integration with specific process and production environments, Mareana’s Connect™ CMC is designed to be a standalone, comprehensive CMC data management solution. It eliminates the need for complex integrations with disparate systems by serving as a centralized repository for all CMC-related information. This simplifies data management and streamlines collaboration across departments, providing a unified platform for all CMC activities. 

Connect™ CMC empowers pharmaceutical companies to overcome the challenges of fragmented data and disparate systems, leading to improved efficiency, data-driven decision-making, and faster time-to-market.

User-Friendly Interface and Regulatory Compliance

Connect™ CMC stands out in the market by prioritizing user-friendliness and accessibility. While other platforms may require extensive training and technical expertise, Connect™ CMC boasts an intuitive interface that users can easily navigate with varying levels of technical knowledge. This means that pharmaceutical and biotech companies can quickly onboard their teams and begin reaping the benefits of digital CMC without a steep learning curve.

In addition to its user-friendly design, Connect™ CMC is built with strict adherence to regulatory standards like CFR Part 11. This ensures data security, integrity, and traceability, giving companies the confidence they need to adopt digital CMC processes without compromising on regulatory compliance. 

This dual focus on user experience and regulatory compliance makes Connect™ CMC a powerful and accessible solution for pharmaceutical and biotech companies of all sizes and technical capabilities.

Beyond Connect™ CMC: Mareana’s Commitment to Excellence

While other digital solutions may offer basic traceability or limited data integration, Connect™ CMC stands apart. It provides unparalleled end-to-end traceability, tracking every step from raw materials to finished products, essential for both small and large molecule development.  The platform seamlessly integrates diverse data sources, from lab notebooks to manufacturing systems, offering a holistic view crucial for complex biologics production. 

Connect™ CMC goes beyond with real-time monitoring and analytics, empowering proactive decision-making for both chemical and biological processes. Furthermore, its user-friendly, compliant design ensures a smooth transition to digital CMC for all users, regardless of technical expertise, while adhering to strict regulatory standards essential for both pharmaceutical and biotech industries. 

This powerful platform empowers pharmaceutical and biotech companies to overcome the complexities of CMC, accelerating drug development and improving patient outcomes across the board.

Choose Mareana, the leader in digital CMC solutions, and unlock the full potential of your pharmaceutical manufacturing processes. Contact us today and request a free demo.