Preclinical Evaluation of Product Related Impurities and Variants
February 15, 2018 - BioPharm International Preclinical Evaluation of Product Related Impurities and Variants The approaches for sample preparation of preclinical evaluation of safety and efficacy are addres…

Tools and Solutions for Separation of Charged mAb Variants
February 15, 2018 - GE Healthcare A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of effi…

Exotoxin Clearance from mAb Samples in a Two-Step Chromatography …
February 15, 2018 - GE Healthcare A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’…

FDA Framework Spurs Advanced Therapies
February 15, 2018 - BioPharm International Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies. By Cynthia A. Challener …

Techniques for Improving Process Development for Exosome-Derived …
February 13, 2018 - Process Development Forum An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences Some therapeutic targets have long frustrated drug developers hoping…

Process Development: What May Lie Ahead in 2018?
February 1, 2018 - Process Development Forum 2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutica…

Troubleshooting Protein Recovery Issues
February 1, 2018 - GE Healthcare Are you frustrated that you aren’t getting the amount of pure protein that you expected? Don’t worry! For example, if your protein recovery is higher …

3rd BioProcessing Asia Preview: Q&A with John Curling
February 1, 2018 - Process Development Forum The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Process Development Forum talks with John Curling, Con…

Robust and Reliable Filtration
January 18, 2018 - GE Healthcare Automate your tangential flow filtration (TFF) process for consistent performance, significant time savings, and extensive data recording. Discover GE’s singl…

Transformative Medicines Challenge FDA and Manufacturers
January 18, 2018 - BioPharm International Transformative Medicines Challenge FDA and Manufacturers New gene therapies and combination products require innovative regulatory approaches. …

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