February 2019
Volume 32, No. 2 |
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| COVER STORY |
Cynthia A. Challener
Leveraging vast quantities of analytical data requires digitalization and platform integration.
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| UPSTREAM PROCESSING |
Jennifer Markarian
Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.
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| DOWNSTREAM PROCESSING |
Steven A. Zdravkovic
Most extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.
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| BioPharm International February Issue
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| MANUFACTURING |
Feliza Mirasol
To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.
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| DEVELOPMENT |
Cynthia A. Challener
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
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| ANALYTICAL SERVICES |
Agnes Shanley
When transferring a method from R&D to quality control, success hinges on discovering where "the best" and "the most reliable" intersect.
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| OPERATIONS |
Amber Lowry
The latest in automation solutions for pharmaceutical laboratories include products in endotoxin detection, liquid handling, and lab workflows.
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| ANALYTICS |
Sylvia Grosse, Stephan Meding, Martin Samonig, Mauro De Pra
Determining a peptide's purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.
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| COLD CHAIN |
Amber Lowry
Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
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| FROM THE EDITOR |
Rita C. Peters
Biosimilars, pricing strategies, and technology investments will influence growth in spending on drugs.
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| REGULATORY BEAT |
Jill Wechsler
Policies emphasize the importance of ensuring data integrity in the United States and abroad.
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| ASK THE EXPERT |
Susan J. Schniepp
Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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| EVENTS |
March 11–13, 2019
March 17–21, 2019
March 18–21, 2019
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