Search results for " Biopharm" in Articles / App Notes
Article
Best Practices in Qualification of Single-Use Systems
Typically, the development engineers at biopharmaceutical companies then work closely with the design engineers and application engineers from suppliers to select components and standard assemblies as…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and development of robust, efficient, and economic purification strategies for new monoclonal antibodies (…
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Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
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What Drove Biopharma Development in 2014?
In addition to developing quality biopharmaceuticals, manufacturers continue to create innovative medicines for treating various diseases, thus driving the trend of next-generation antibody-based ther…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
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 implementi…
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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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Single-Domain Antibodies for Brain Targeting
With 25 mAb products on the market and more than 100 undergoing clinical trials (1-3), it is evident that engineered antibodies have come of age as biopharmaceuticals (4).
Intact antibodies (immun…
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EMA Invites Comments on New Guidance for Vaccine Development
The European Medicines Agency (EMA) has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical req…
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Single-Use and Continuous Processing Technologies Change Facility Design
In parallel, another change on the horizon in biopharmaceutical plants is continuous processing--the impact of which could be as significant in the pharmaceutical industry as it was in the car and ele…
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Applying GMPs to the BioPharma Supply Chain
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be available when needed, effective for their intended purpose, and safe to use. At an operational level, it is v…