Search results for " industry 4.0"

Article A Q&A With Jeff Carter on Trends in Single-Use Technologies
Process Development Forum speaks with Jeff Carter, Strategic Projects Leader at Cytiva, and first Vice Chair on the executive board of the Bio-Process Systems Alliance (BPSA). What general trend…

Article Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing? By Rajeev J. Ram In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…

Article Mechanistic Modeling: Does it Have a Future in Process Development?
The application of mechanistic models for process development and optimization has been a topic of discussion in the pharmaceutical industry for many years. Mechanistic models are considered as an a…

Article A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

Article Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation. There is a clear link between a country’s rate of economic development and the strength of its intellectual p…

Article Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.   Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…

Article Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing. The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…

Article FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages. Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…

Article Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Spivey and Lane Click here to view more Q&As >> Analytic considerations for upstream processing – covering Process Analytic Technology (PAT), time-savings versus off-line ana…

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