Opportunities in Continuous Manufacturing of Large Molecules
Cover: Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) would, in principle, be even more justified for both quality and business gains. This article brie y reviews continuous biomanufacturing at a time of very high and global demand for vaccines as well as increased demand for cell and gene therapy products.
Continuous Manufacturing As a Tool for Accelerated Development
Feature: Continuous manufacturing offers one way the pharmaceutical industry can accelerate development of the drug product control strategy to ensure a robust and reliable supply of medicine to the clinic and/or market. This article explores the promise of CM in enhancing accelerated development, as evidenced by experience in solid oral products.
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Feature: Application of continuous manufacturing in the pharmaceutical industry is gaining momentum. Most of the current experience is based on oral solid dosage projects but in the future CM should not be limited to these dosage forms. In this article, the regulatory acceptability of CM to produce pharmaceuticals is demonstrated in different regions, including the “rest of the world” (i.e., regulators in nations and regions other than the US, EU, Japan, and Canada) through case studies.
Software as a Medical Device Fundamentals
TECHNICAL: Software as a medical device (SaMD) is software intended to be used for one or more medical purposes without being part of a medical device. Although SaMD applications have the potential to improve patient care and expand the pharmaceutical industry’s product lines, companies must understand the distinctive characteristics of this software and address the risks and challenges related to SaMD design, development, regulation, and life-cycle management.
Medical Device UDI Components Management in the European Union
TECHNICAL: Since 2019, the ISPE France Affiliate's Unique Device Identification (UDI) Medical Device Work Group has been producing tools to help project stakeholders within the EU or overseas to understand and comply with EU regulations of UDIs in medical devices. Some of those tools are highlighted in the article.