In today’s digital age, businesses generate an enormous amount of data. However, a significant portion of this data remains unstructured, causing challenges for organizations across various industries. One prominent factor contributing to this problem is the use of manual, paper-based systems in many sectors, including the pharmaceutical and biopharmaceutical industries. These outdated systems impede the efficient handling and processing of data, leading to data inaccuracies, process inefficiencies, and increased expenses. The need for a solution that can transform unstructured data into valuable business insights has become paramount.

Unstructured data: Factors contributing to its prevalence

The biopharma upstream/downstream process involves various stages and activities such as cell development, chromatography, viral clearance, final formulation, and sterile filtration, among others. These processes generate a significant amount of data and documentation(paper mostly), leading to several challenges:

  • Manually Intensive Data Management: The management of data in the biopharma industry often relies on manual processes, which can be time-consuming and error-prone. This includes data entry, data tracking, and data analysis, among other tasks.
  • Searchability & Findability: With a variety of data files in different formats, including PDFs, Word documents, PowerPoint presentations, and spreadsheets, it can be challenging to search for and find specific information when needed. This lack of searchability and findability can hinder decision-making and slow down processes.
  • Unstructured Data: Unstructured data refers to information that is not organized or easily searchable. In the context of biopharma production processes, unstructured data can include scanned PDFs, handwritten notes, or data collected from various sources that are not standardized or organized in a structured manner.
  • Time Consuming and Capital-Intensive: Dealing with inconsistent data formats, file flow, traceability across departments, and data harmonization can consume significant time and resources. The manual handling of data and the need for data verification and validation add to the overall capital investment required for efficient data management.
  • Reasons for Unstructured Data: Unstructured data may arise due to a variety of factors in the biopharma industry. These factors include the use of legacy systems or outdated technologies that do not support structured data, diverse data sources that produce information in different formats, and the historical reliance on paper-based documentation systems that are not easily digitized.

To address these challenges, the industry needs to adopt digital solutions and technologies such as data management systems, electronic documentation systems, and advanced data analytics tools. Implementing standardized data formats, automating data entry and analysis processes, and promoting data sharing and collaboration across departments that significantly improve data management efficiency in the biopharma industry.

CPV-AutoTM NXG : A Potential Solution

Aventior’s CPV-AutoTM NXG platform emerged as a promising way to manage unstructured data. Primarily developed for the pharmaceutical and biopharmaceutical industries. CPV-AutoTM NXG employs cutting-edge technologies, including Artificial Intelligence and Natural Language Processing, to unlock the hidden insights within unstructured data. By leveraging advanced algorithms, the platform rapidly processes and analyzes vast amounts of unstructured data, transforming it into structured, actionable information.

Aventior offers a one-stop solution for document digitization. By automating the conversion of paper-based batch records into structured data, the platform enables organizations to streamline their data management processes, achieve compliance, and unlock valuable insights.

Through the use of OCR (optical character recognition), text analytics, and image processing, the AI engine extracts important data from paper records, including measurements, instrument reports, numbers, and handwritten notes.

The extracted data is then transformed into structured formats, compatible with downstream analytics platforms commonly used in the industry. This digitization process ensures data Integrity, Efficiency, Accuracy, and GxP compliance, as CPV-AutoTM NXG adheres to industry standards such as 21 CFR Part 11 and GAMP 5.

Integrity: CPV-AutoTM NXG ensures the integrity of data throughout the digitization process. With its AI-assisted technology, the platform guarantees 100% correctness of output data, eliminating the risk of errors and inaccuracies commonly associated with manual data entry.

Efficiency: By automating paper-based systems, CPV-AutoTM NXG improves operational efficiency significantly. The platform creates structured data outputs that are compatible with popular downstream analytics platforms, allowing businesses to analyze and derive meaningful insights from their data effortlessly.

Accuracy: Leveraging advanced technologies such as optical character recognition (OCR), text analytics, and image processing, CPV-AutoTM NXG accurately captures and extracts important data from paper batch records. This ensures that businesses have access to reliable and precise information for critical decision-making.

GxP Compliance: CPV-AutoTM NXG adheres to the highest industry standards, including 21 CFR Part 11 and GAMP 5. The platform undergoes rigorous validation at every step to ensure quality and compliance with established GxP norms, providing businesses with peace of mind.

Real-time Monitoring and Intervention: With CPV-AutoTM NXG, manufacturing (CPV) and patient records can be recorded in real-time or near real-time. This capability enables Quality Control teams to intervene promptly, minimizing risks and ensuring product quality throughout the production process.

Working Principle : CPV-AutoTM NXG

CPV-AutoTM NXG follows a multi-step process to unlock insights from unstructured data:

  • Data Acquisition: It collects unstructured data from various sources, including, PDFs, Word/Text documents, PowerPoint presentations, and spreadsheets. The solution is designed to handle large volumes of data from diverse sources.
  • Data Preprocessing: CPV-AutoTM NXG cleans and preprocesses the unstructured data to remove noise, standardize formats, and enhance data quality. This step involves techniques such as text parsing, entity recognition, sentiment analysis, and image preprocessing.
  • Data Enrichment: The solution enriches the unstructured data by augmenting it with additional information. For example, it may classify documents into predefined categories, extract named entities, recognize objects in images, or perform language translation.
  • Analysis and Insights Generation: CPV-AutoTM NXG employs advanced AI and ML algorithms to analyze the enriched data and extract meaningful insights. This includes sentiment analysis, topic modeling, image recognition, document clustering, text summarization, and more.
  • Visualization and Reporting: The solution provides intuitive visualizations and reports to present the derived insights in a digestible format. This enables businesses to make informed decisions based on the analyzed data.

Business Impact : CPV-AutoTM NXG

Implementing CPV-AutoTM NXG can have a transformative impact on businesses across multiple sectors. By digitizing paper batch records, organizations can experience a significant decrease in processing time and total cost of ownership. With batch records in structured formats, businesses can more easily search, analyze, and compare data across different batches or lots. The near real-time monitoring of Critical Production Parameters (CPP) allows for timely intervention and informed decision-making, enhancing product quality and process control.

Furthermore, CPV-AutoTM NXG’s AI-assisted technology ensures the correctness of output data, reducing inaccuracies and the risk of errors. The platform’s ability to handle both template and non-template based batch records accommodates diverse data structures and workflows.

The implementation of CPV-AutoTM NXG has a profound impact on businesses across industries. Here are some key benefits:

  • Quicker Data Processing: CPV-AutoTM NXG accelerates data processing by providing Critical Production Parameters (CPP) up to 15 times faster than traditional methods. This enables businesses to make informed decisions swiftly, enhancing operational efficiency and agility.
  • Enhanced Data Security: The platform adheres to industry-leading data security standards. Being 21-CFR Part 11 compliant and meeting GxP norms, CPV-AutoTM NXG ensures that your sensitive information remains protected. Its Cloud-based validated solution employs state-of-the-art security protocols.
  • Improved Decision-Making: By converting unstructured data into structured insights, CPV-AutoTM NXG empowers businesses to make data-driven decisions. Actionable information derived from unstructured data can reveal customer preferences, market trends, and operational inefficiencies, leading to optimized strategies and increased competitiveness.

Case Studies : Success Stories with CPV-AutoTM

Multiple organizations have already benefited from implementing CPV-AutoTM NXG. For example, a biopharmaceutical company faced the challenge of managing unstructured data from various stages of their manufacturing process and engineering runs.

  • Case Study: Digital Transformation Solution for Bio-Manufacturing Operations
    A research-based global biopharmaceutical company faced challenges in managing unstructured data from various stages of their bio-manufacturing processes and engineering runs. By implementing the CPV-AutoTM platform, they achieved remarkable results. The platform’s AI-assisted conversion capabilities enabled the detection and extraction of crucial information from unstructured data, significantly reducing the time required for parameter search and data analysis by 80%. Integration with their data warehouse facilitated efficient data storage and easy access for comparison and analysis. The structured data obtained empowered the client to make informed decisions, optimize manufacturing processes, and drive operational efficiency, leading to a successful digital transformation in their bio-manufacturing operations.
  • Case Study: Data Strategy & Transformation Services in Monoclonal Antibody Production Process
    A global biopharmaceutical company faced challenges in incorporating genetic-level analysis for monoclonal antibody (mAb) characterization due to unstructured data spanning multiple unit operations and lots. By implementing Data Strategy & Transformation Services, including AI-assisted conversion, machine learning algorithms, and data flagging mechanisms, the company successfully streamlined analysis, merged data from various runs/cycles, and identified outliers for early intervention and informed decision-making. This transformation enabled researchers to gain comprehensive insights into mAbs, leading to improved research outcomes and potential advancements in patient treatments.

Conclusion

Unstructured data holds immense potential for businesses, but extracting insights from it can be a complex task. However, with advanced solutions like CPV-AutoTM NXG, businesses can overcome this challenge and unlock valuable insights hidden within unstructured data. By leveraging AI, ML, NLP, and computer vision, CPV-AutoTM NXG empowers businesses to make data-driven decisions, improve operational efficiency, and gain a competitive edge in today’s data-driven world. Embracing unstructured data solutions is the key to unlocking business insights and staying ahead in the digital era.

In a world where data is king, embracing unstructured data solutions is the key to unlocking business insights and driving success in today’s rapidly evolving landscape. CPV-AutoTM NXG stands as a powerful tool, helping organizations overcome the challenges of unstructured data and opening doors to unprecedented opportunities. Are you ready to harness the power of structured data and revolutionize your business?

To know further details about our solution, do email us at [email protected].