This article defines what constitutes a holistic control strategy in pharmaceutical development and manufacturing. It highlights the limitations of traditional, siloed approaches and demonstrates the added value of integrating these approaches across multiple dimensions. By identifying key gaps and proposing technological enablers, the article outlines a path toward a more comprehensive,...
In the bustling city of Boston, amidst the vibrant biotech community, the 2024 ISPE Biotechnology Conference will gather industry leaders and innovators for a pivotal set of discussions on Track 4: Lifecycle...
Are you interested in developing a new bioproduct and attracted by the incredible potentials of new modalities like ATMPs, Cell and Gene Therapies, AAVs, oligonucleotides, multi-specificity antibodies, mRNA vaccines, and more? Despite the appeal of these new modalities, there is a significant risk of failure due to the many unknowns associated with these new technologies.
This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical Engineering.
Digital transformation and digitalization are on the agenda for all organizations in the biopharmaceutical industry. But what are the main enablers of intelligent manufacturing? We hypothesize that data science–derived manufacturing process and product understanding is the main driver of digitalization in the bioprocessing industry for biologics manufacturing. In this article, the first of a...
