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BioPharm International-02-01-2019
BioPharm International
Small-Batch Aseptic Fill/Finish System
February 02, 2019
Product Spotlight
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The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.
Supply Chain Challenges for Single-Use Systems
February 01, 2019
Features
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Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.
Sustainability in Disposal of Single-Use Systems
February 01, 2019
Features
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Single-use components for biopharmaceutical manufacturing have a lower environmental impact than reusable components, but disposal is still a consideration.
Sterile Boot Covers
February 01, 2019
Product Spotlight
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Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.
Innovations Maintain the Cold Chain
February 01, 2019
Features
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Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
What’s New in Lab Automation
February 01, 2019
Features
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The latest in automation solutions for pharmaceutical laboratories include products in endotoxin detection, liquid handling, and lab workflows.
Automation in the Lab: What to Consider
February 01, 2019
Features
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BioPharm International spoke with Stuart Ward, head of Business Analysis at IDBS, about what needs to be considered when integrating automation solutions into lab workflows for operational tasks.
As Drug Spending Slows, Investment Must Pick Up
February 01, 2019
From the Editor
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Biosimilars, pricing strategies, and technology investments will influence growth in spending on drugs.
Effective Root Cause Determination
February 01, 2019
Ask the Expert
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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.
FDA Promotes Quality Standards to Reduce Shortages
February 01, 2019
Regulatory Beat
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Policies emphasize the importance of ensuring data integrity in the United States and abroad.
Taking Stock of Biologic Fill/Finish Best Practices
February 01, 2019
Features
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To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.
Advances in Engineering of Protein-Based APIs
February 01, 2019
Features
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New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
Nurturing Knowledge from Disparate Data Streams
February 01, 2019
Cover Story
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Leveraging vast quantities of analytical data requires digitalization and platform integration.
The Benefits of Combining UHPLC-UV and MS for Peptide Impurity Profiling
February 01, 2019
Features
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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.
Analytical Method Transfer: Don’t Oversimplify
February 01, 2019
Features
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When transferring a method from R&D to QC, success hinges on discovering where “the best” and “the most reliable” intersect.
Understanding Leaching from Stoppers into Lyophilized Drugs
February 01, 2019
Features
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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.
BioPharm International, February 2019 Issue (PDF)
February 01, 2019
Issue PDF
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Click the title above to open the BioPharm International February 2019 issue in an interactive PDF format.