Search results for " 2016" in Articles / App Notes
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
By Alex Chatel and …
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
New Therapies Present Scaling Challenges
26, 2016.
3. M. Varley and M. Brady, “To Scale-Up or Scale-Out? The Challenge of Commercializing Cell Therapies,” Cambridge-Design.com, July 11, 2017.
4. G.M. Pigeau, E. Csaszar, and A. D…
Article
Driving Improved Access to Biosimilars
…y 600% between 2001 and 2015, with the average US list price rising by 15% per year between 2012 and 2016. He suggested that biosimilar versions of insulin would be likely to reach the market over th…
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Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
Article
FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
Article
3rd BioProcessing Asia Preview: Q&A with John Curling
At BPA 2016, a presentation addressing challenges in the development of advanced therapy medicines attracted much attention. Given approvals of gene and cell therapy treatments in 2016-2017 and recent…