How iText helps meet challenges in rapid vaccine development

Despite developing COVID19 vaccines in record time, 2021 brings enormous challenges to the industry in terms of the high-volume production and delivery requirements to meet demand. Delays in the delivery of millions of doses, lack of transparency in manufacturing processes, etc. recently caused EU officials to lash out at a pharmaceutical firm. Clearly, further challenges await before this pandemic is over.

However, technology can offer some solutions. Pharmaceutical high-value manufacturing manufacturers have in recent years increasingly embraced new technologies to speed up the process of bringing new medicines to market, as well as provide greater insight into their manufacturing processes. In particular, there has been a significant shift towards the application of Process Analytical Techniques (PAT) in online spectroscopy, Chemometrics and calibration modelling allows the predication and monitoring of Critical Quality Attributes in real-time.

How iText is used in the pharmaceutical industry

Multiple well-known pharmaceutical players use iText; both directly, and indirectly through software vendors. In a recent case study with Perceptive Engineering, we explored how they integrated the iText 7 Core PDF library into their PharmaMV solution which offers a comprehensive suite of software tools encompassing multi-variate analysis, modelling, data visualization, process monitoring, control, and optimization. The platform is used to detect and eliminate faults, improve product quality, and optimize batch and continuous pharmaceutical process units.

PharmaMV was designed to meet the regulatory requirements of the Pharmaceutical industry, such as the United States Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance, which defines the requirements for computer-based systems in the Pharmaceutical and food manufacturing industries.

Generating compliant PDF reports for auditing and project tracking

iText 7 Core forms an essential component of the RT Manager, which as the name suggests manages real-time stations and implements the control and monitoring of processes. It also provides version control and configuration reporting of projects and models through its inbuilt database and allows seamless integration with production recipe/batch management systems.

This reporting contains data for project versions, summaries, configuration, events, and methods, to comply with industry regulations. The report need to be presented in a manageable and consistent human-readable format for accurate project tracking and auditing to take place.

PDF is a natural fit for these requirements. They chose iText since they wanted to embed a PDF reporting engine and integrate it with their existing Java tools. As these reports can be many thousands of pages and contain large amounts of data, the ease of use, stability, and scalability of iText 7 Core was an important factor.

Workflows which require advanced PDF features such as PDF/A or PDF/UA compliance for archiving or accessibility requirements or PDF digital signatures for secure document workflows are not left behind either, since all this functionality is built into iText 7 Core.

There’s more than just Core

The various iText 7 add-ons which comprise the iText 7 Suite can also offer important benefits to a pharmaceutical industry workflow; from pdfCalligraph which enables advanced typography for PDF to support complex languages and writing systems, to pdf2Data which intelligently recognizes and extracts data from PDF documents based on areas and rules defined in a template, and pdfOCR which uses optical character recognition to convert scanned documents, PDFs and images into fully ISO-compliant PDF or PDF/A-3u files making it possible to access and process the text they contain, or for long-term archiving requirements.

Open-Source DNA

iText began life as an open-source project over 20 years ago, and it remains an important part of our DNA to this day. We strongly believe in the open-source ethos, and that the open-source community drives innovation, ultimately benefitting our users and customers around the globe, and saving them time and money developing great software products.

The iText 7 Core library and many of its add-ons are freely available under the AGPL terms; while commercial licensing is available for those who wish to protect their intellectual property and remove the copyleft restrictions for using iText, or use the closed-source add-ons and software we develop.

Commercial licensing of iText’s software doesn’t just pay the bills and keep the roof over our heads; it also enables us to employ a team of developers that work on developing and improving iText full-time, and in-house engineers to provide professional support and maintenance to our customers, guaranteeing them support when they need it.