BioPharm International-02-01-2019

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.

Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.

Single-use components for biopharmaceutical manufacturing have a lower environmental impact than reusable components, but disposal is still a consideration.

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.

Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.

The latest in automation solutions for pharmaceutical laboratories include products in endotoxin detection, liquid handling, and lab workflows.

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.

Biosimilars, pricing strategies, and technology investments will influence growth in spending on drugs.

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.

Policies emphasize the importance of ensuring data integrity in the United States and abroad.

To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.

New platform technologies, advanced modeling tools, and addressing patient needs are important developments.

Leveraging vast quantities of analytical data requires digitalization and platform integration.

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.

When transferring a method from R&D to QC, success hinges on discovering where “the best” and “the most reliable” intersect.

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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