Search results for " guidelines" in Articles / App Notes
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…
Article
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
Article
Process Development: 2020 Reflections and 2021 Possibilities
Scaling up viral vector and virus manufacturing processes prompts the need for discussion on general guidelines for how to go about the scale-up process, which was of particular interest to Bioprocess…
Article
Manufacturing of Vaccines and Viral Vectors
In this article, general guidelines for scaling up a viral vector and virus manufacturing processes are discussed.
Article
2019’s Top Bioprocessing Trends and What to Expect in 2020
… economic advantages compared with more traditional methods, all the while staying within regulatory guidelines.
Efficiency Improved by New Technologies
Technological advances showcased…
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
Moving PAT from Concept to Reality
“Some concepts of modern automation technologies and sensor technologies are not yet covered by regulatory guidelines, particularly those used for multivariate data analysis, which takes all available…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
Article
Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
Article
Applying GMPs in Stages of Development
EC, EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use.
6. FDA, G…