BioPharm International-08-01-2019

BioPharm International

FDA Maps Strategies to Advance Cell and Gene Therapies

August 01, 2019

Regulatory Beat

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New tools and policies aim to support more complex manufacturing processes.

Gene-Editing Techniques Target New Applications

August 01, 2019

Features

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Experts explore the role gene-editing techniques can play in regenerative medicine and cell-line development.

The Moon, the Stars, and the Science Lab

August 01, 2019

From the Editor

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Half a century after man first walked on the moon, space-based science is exploring benefits for Planet Earth.

Quality Risk Management Plans Create Effective Quality Systems

August 01, 2019

Ask the Expert

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Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Best Practices in the QC Micro Laboratory

August 01, 2019

Features

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Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.

Accepting the Challenge of Protein Characterization

August 01, 2019

Features

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Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.

Plate Reader Offers Real-Time Detection and Analysis

August 01, 2019

Product Spotlight

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Tecan’s Spark Cyto cell plate reader offers real-time detection and analysis of biological, chemical, and physical events while consistently capturing the maximum amount of data from every well.

Microbioreactor System

August 01, 2019

Product Spotlight

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Sartorius Stedim Biotech’s Generation 2 ambr 15 cell culture microbioreactor system offers increased flexibility and expanded capability for clone selection, media and feed optimization, and early process development work.

BioPharm International, August 2019 Issue (PDF)

August 01, 2019

Issue PDF

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