BioPharm International-11-01-2019

Upstream Processing

November 11, 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.

Upstream Processing

November 08, 2019

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.

Downstream Processing

November 01, 2019

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.

Product Spotlight

November 01, 2019

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

Product Spotlight

November 01, 2019

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

Regulatory Beat

November 01, 2019

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

Ask the Expert

November 01, 2019

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.

Manufacturing

November 01, 2019

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

Cover Story

November 01, 2019

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.

Cover Story

November 01, 2019

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

From the Editor

November 01, 2019

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

Analytics

November 01, 2019

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.

Perspectives on Outsourcing

November 01, 2019

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

Operations

November 01, 2019

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

Click the title above to open the BioPharm International November 2019 issue in an interactive PDF format.