Search results for " innovation" in Articles / App Notes
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…
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2014 Manufacturing Trends and Outlook
Past and future innovation
Respondents revealed insight about recent innovations that have improved process efficiencies. Equipment and products related to disposable systems were most frequentl…
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Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
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State of Quality and Compliance in the Biopharmaceutical Industry
However, after more than 10 years since the launch of these initiatives, manufacturing innovation and product quality do not appear to have improved to the extent originally envisioned. As recent year…
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FDA Seeks Metrics to Define Drug Quality
This effort is supported by the FDA Safety and Innovation Act (FDASIA), which requires FDA to draft a strategic plan for preventing and mitigating drug shortages. Policy makers want to know if FDA com…
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Quality by design for biotechnology products—part 1
The QbD approach can be maintained throughout the lifecycle of the product to facilitate innovation and continuous improvement based on expanded knowledge and new technologies. This knowledge is gaine…
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Sterilization Trends for Single-Use Consumables
… and Research Advanced Technologies Team (CATT), as well as the European Medicine Agency’s Quality Innovation Group (QIG) and Japan’s Pharmaceutical and Medical Devices Agency.
Many of the agenci…
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Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
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Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
As you may already know, many biopharmaceutical manufacturers are producing drugs at higher concentrations. This trend is mainly driven by the demand for subcutaneous drugs that are self-admin…
Article
Evaluating the Use of Continuous Chromatography
Enabling adoption
BioPharm: What key innovations have been instrumental in promoting the use or adoption of continuous chromatography?
Rozanas (Cytiva): [Some] continuous chromatography systems …