A leading organization in small molecule therapies was facing a challenge in ensuring consistent CPV initiatives across their different manufacturing sites was maintaining a uniform standard of data in their manufacturing analytics. A software solution that was purpose-built for biopharmaceutical manufacturing provided a strong foundation to streamline the validation of manufacturing analytics for CPV and reporting.

Developing the proper formulation of active ingredients (APIs) and excipients is almost as important in designing a new therapeutic as the APIs themselves. Sanofi’s challenge was removing the formulations bottleneck in its pharmaceutical development workflow by improving its autoxidation risk assessments of potential formulations. By implementing BIOVIA Materials Studio they were able to removed the need for “trial-and-error” driven experiments and maximized the value of scientists’ time.

Data gathering was difficult for an emerging specialty pharmaceutical company, as data resided in paper-based documents, spreadsheets and complex equipment systems. Being unable to garner insights from the data for impactful decisions drove them to seek a solution that could accelerate data aggregation, modeling and prediction.

Following several mergers and acquisitions, a biopharmaceutical company had to manage an increasing amount of data from disparate online and offline sources. A solution allowed them to access data from various sources and to feed other systems with data quickly to support the company’s digital science and manufacturing informatics strategies.

Meta Biomed's scientists ran hundreds of experiments, but they lacked a clearly defined way of sharing information and knowledge between individuals and teams. They also wanted to centralize their product development data and achieve a more structured way of working to boost innovation, embed quality throughout the supply chain and accelerate product certifications—especially as they sought to become a leading supplier of surgical sutures in the global market. A single, centralized database solution now allows them to hold all of their product development data.

To ensure that a commercial biomanufacturing process is in a state of control, life science companies must create and successfully execute initiatives to meet continued process verification (CPV) and other monitoring guidelines. Learn how to navigate the major steps of implementing a global monitoring plan for continued process verification.

Chemical inventory management processes that have not been optimized with technology and best practices can negatively affect operational effectiveness and efficiency. A real-time chemical inventory management system increases the organization’s efficiency and productivity by: consolidating the resources needed for inventory reporting, MSDS management and inventory management; reducing chemical purchase, storage and disposal costs; and, most importantly, providing greater operational efficiency in the laboratory.

Laboratory organizations need an environment that facilitates and optimizes collaboration, experiment execution, documentation and data management in the different labs from R&D through manufacturing to commercialization. By implementing a digital lab solution you can bridge the innovation and productivity gaps in research, development, manufacturing and quality, and enable successful technology transfer across new product development and production operations.

Many research organizations are facing a maelstrom of increasing regulation concerning on-site chemicals and an ever-growing volume of chemical-related data to manage and report. Chemical inventory management can be time-consuming; it can hamper workflows; and – worst of all – it can trigger numerous non-compliance determinations. This guide presents a best practices solution to this dilemma; e.g., how to compare and select a digital chemical inventory management system that streamlines workflows  throughout the organization and brings chemical inventory under control.

Over the last few decades, replacement of outdated paper-based data management systems has been identified as a means to accelerate this process. While the implementation of electronic systems led to reduced cycle times and compliance risk, issues remain with systems existing in departmental silos and non-standardization of data across the drug development continuum. To satisfy the requirement of drug development companies for efficient data and technology transfer, standardization of data and technology transfer across the entire pharmaceutical product lifecycle is needed.

Despite advances in technology that have improved the productivity, performance and predictability of scientific work in laboratories, data compatibility problems like this persist. Systems, applications and devices lack a standard way to share information with each other. An informatics platform that offers software-automated, standardized instrument integration services solution is available.

In today’s competitive environment it is the objective of all life science manufacturing companies to minimize the risks of compliance non-conformance and the significant associated post-event costs. Organizations can avoid these risks with systems that include the procedures for QC lab testing with the according specifications, and that can enforce their execution. Read how technology advances can provide an assured procedural compliance “execution” process that can be applied to any defined workflow.

When it comes to drug discovery and development, employing these technologies has become an existential challenge for the pharmaceutical industry. So how can these technologies help the pharmaceutical companies reduce the staggering expense and amount of time it takes to develop new therapeutics, getting there sooner, with less compounds needing to be tested and proved? AI & Machine Learning (ML) are deployed to explore potential drug candidates faster, able to meet a particular target product profile.

Enhancing project management with analytics creates project intelligence, shifting a task-based activity to a performance-driven one. This article discusses the importance of using actionable insights within pharmaceutical and biotech industries and the benefits that they provide.

Larger pharma organization have evolved into hierarchical silos due to a combination of legacy organizational structures, mergers and acquisitions, and lack of a holisitic approach to innovation.