Opportunities in Continuous Manufacturing of Large Molecules Cover: Continuous manufacturing has attracted significant interest over the past decade...
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...
The ISPE OSD Community of Practice Continuous Manufacturing Subcommittee is planning a Good Practice Guide to capture information developed over several years by the team to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest where...
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum. Most of the current experience is based on oral solid dosage (OSD) projects but in the future continuous manufacturing should not be limited to these dosage forms. In this article, the regulatory...
Continuous manufacturing (CM) 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 continuous manufacturing in enhancing...
14 Presentations Featuring 5+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest...
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...
Sampling is the selection of a representative portion of the population to make inferences about the entire population. In pharmaceutical manufacturing, samples are drawn from different stages of the process for both controlling process parameters and assessing drug product quality. In the case of...
Continuous manufacturing (CM) technologies have recently been implemented in the pharmaceutical industry for process development, clinical trials, and commercial supply. This article is a high-level summary of a recently published ISPE Discussion Paper that details unique aspects of CM related to...
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the...
