Cover: Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector. One approach to managing these uncertainties at the facility design stage is to develop operational models and perform computer simulations. The information generated via these simulations enables management to make data-driven decisions.
Feature: This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including regulatory de nitions, product life cycles, processing systems, relevant cell therapy technologies and equipment, biosafety, cross contamination, facility automation, and layout options.
Feature: Oligonucleotides are a relatively new class of drugs, composed of natural and synthetic nucleotides. This article focuses on synthetic antisense oligonucleotides (single strand 16–22 mers) and small interfering RNA (double strands formed by hybridization of a pair of complementary sense and antisense strands, 19–25 mers).
Feature: Biopharmaceuticals have brought significant transformations in product development, strategy, technology, and operations. This ongoing transformational process was the main theme of the fourth annual ISPE Europe Biotechnology Conference, 25–26 September 2019, in Brussels.
Technical: Justifying Investment in Manufacturing Execution Systems Investments in manufacturing execution system (MES) applications may reduce costs and increase revenues, but they also might compete with other investment priorities. This article offers guidance for life sciences companies considering investment in MES applications, including how to measure MES-related cash flow and reasonably evaluate an investment in MES versus other alternatives.