BioPharm International-11-01-2019

Bob Lenich, Emerson's business director for global life sciences, shares insights on where biopharma modeling is now, and where it is heading in the near future.

Legal experts in biopharmaceutical patent law shed some light on trends and recent news.

Modeling is being used for everything from yield improvement to facility design, but new initiatives plan to broaden its reach, both upstream and downstream.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

The latest advances in downstream technologies include stainless-steel liquid chromatography columns, sensing and control units for hygienic valves, a wettable phase for separation and purification, a buffer delivery platform, and a new filter integrity tester.

GE Healthcare Life Sciences launched the new KUBio box for the production of viral vector-based gene therapies.

Kimberly-Clark Professional introduced the Kimtech A8 Zippered Lab Coat for liquid and particle protection for ISO 7 and 8 or higher cleanroom environments.

FDA readies more efficient oversight processes while advancing collaboration with Europe.

It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.

Limitations in traditional flu vaccine manufacturing methods underline the need for shifting to modern technologies.

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

FDA report says drug shortages are underappreciated and patients pay a price.

Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.

Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.

Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.

The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.

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