Cover: Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of things are becoming requirements for modern implementations including advanced therapy medicinal products (ATMPs). This article addresses artificial intelligence and how it can help deliver on the promise of Industry 4.0 approaches to the entire product life cycle, from biology and medicine through product research and development, to validation, manufacturing, and post-launch surveillance.
Feature: Historically, cell therapies are used to treat patients with cancer after relapse from other approved treatment modalities, or if no approved treatment is available. However, the introduction of allogeneic cell therapies has created exciting opportunities to broaden access to cell-based treatments. With advancements in manufacturing, developers are becoming increasingly interested in commercializing allogenic therapies, bringing them one step closer to becoming broadly available to more patients.
Feature: With so many options for personalizing our lives, is the personalization of medicine far behind? With all the data available, how can the industry bring personalized medicine to patients? This article explores what is currently available and where the pharmaceutical industry can move forward to better serve patient needs.
TECHNICAL: Viral inactivation (VI) is a critical step in ensuring the safety of monoclonal antibody (mAb), Fc fusion, and recombinant protein therapeutics and it is typically an important component of an overall virus control strategy for downstream biotherapeutic production processes. Considerations for successful implementation of an inline VI process are discussed in this article.
TECHNICAL: Use of software as a service (SaaS) applications within the life sciences industry is growing. This article reviews the issues and challenges faced by SaaS providers and identifi es the qualities of successful providers for this highly regulated industry.