A control strategy developed using a science- and risk-based approach will ensure that reproducible product quality is achieved throughout the product life cycle, while maintaining the efficiency, robustness, and flexibility that continuous manufacturing has to offer.
Holistic Control Strategies for Continuous Manufacturing
Cover: A control strategy developed using a science- and risk-based approach will ensure that reproducible product quality is achieved throughout the product life cycle, while maintaining the efficiency, robustness, and flexibility that continuous manufacturing has to offer.
Process Validation in the Context of Small-Molecule Drug Substance and Drug Product Continuous Manufacturing Processes
Features: Highlights from a recently published Discussion Paper detail unique aspects of continuous manufacturing related to each stage of the process verification life cycle.
Regulatory Progress in Global Advancement of Continuous Manufacturing for Pharmaceuticals
Features: Regulatory agencies are reviewing each continuous manufacturing application based on its individual merit, using a science- and risk-based approach to assess the manufacturing process and the product characteristics. This nonprescriptive approach drives innovative, creative thinking and supports the continued growth of CM for small- and large-molecule applications.
Ten Frequently Asked Questions About Serialization
Features: Drug manufacturers that market products internationally must continue to reorganize their operations to comply with many different standards
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations. Similar to batch manufacturing, CM requires a comprehensive and holistic control strategy...
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 cost of purchasing the continuous equipment, the resources and expertise required for additional...
To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161 of 2016. Worldwide, other anticounterfeiting regulations are already in place or coming soon in...
From the time when we were young, we have been taught to avoid failure. You are told to get the best grades in school, which will lead to getting into college. And when you graduate, you’ll get a good job, work hard, and the promotions will come. At no point did anyone ever tell us to fail! But failure is part of life and we all have personal and professional failures despite our best...
ISPE’s initiative to transform industry-generic 4.0 models for pharma operations will help the industry benefit from digitalization.
As members of the Architecture Team of the ISPE Pharma 4.0™ Plug & Produce Initiative, we would like to share the principles we have developed with the broader life sciences community. Our aim is to foster further exchange and...
Young Professional Brita Salzmann, a Process Engineer with CRB and member of the ISPE Greater Los Angeles Chapter, loves the challenge of backpacking. She continues to add to her hiking resume, which includes treks across segments of the John Muir Trail in the Sierra Nevada Mountains of California, 14,000-foot-high peaks in Colorado, and national parks throughout the West. For Salzmann, the...
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 a traditional batch process, a fixed amount of material is processed and the batch quality is...
As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been considering operational alternatives to reduce production costs and increase manufacturing rates.
Initially, the American College of Rheumatology urged caution around the use of biosimilars. Information about the manufacturing process for a branded biologic is proprietary; a biosimilar manufacturer will not have access to the details of the process, so how could they guarantee their product would be the same? It is now well accepted by the scientific community that biosimilars are safe,...
