Search results for " guidance" in Articles / App Notes
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…mpling of powder raw materials requires rapid material usage post-sampling to comply with regulatory guidance.
The physical properties of powders require extensive cleaning of clas…
Article
Make the Switch from ELISA to Biacore™ SPR-Based Assays Today
General guidance on how to convert an existing ELISA assay to a Biacore surface plasmon resonance (SPR) assay and how, by doing so, you can get results in less than half the time compared with ELISA. …
Article
Supply Chain Challenges for Single-Use Systems
Managing change is challenging in a rapidly growing market with continuous evolving guidance that requires a smart risk-based approach. One size does not fit all. We have extensive knowledge of our cu…
Article
A Look into the Future of Biopharmaceutical Quality
…uidelines would not ensure the quality of biologics in the future, but it’s likely that regulatory guidance documents will continue to be revised and updated over time to adopt industry best practice…
Article
Biopharma Seeks Balance
The methods FDA uses to regulate gene and cell therapies will evolve, Marks said, and Gottlieb noted that FDA will produce guidance documents for gene therapy in 2018.
A fine balance
For patie…
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
Impurity Testing of Biologic Drug Products
Other aspects of method validation are more easily derived from the guidance given in ICH Q2 (R1).
Analytical methods
BioPharm: What are the commonly used analytical methods for charac…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
New guidance documents will be part of the framework, which covers therapeutic tissue engineering products, human cell and tissue products, and certain combination products intended to treat serious o…
Article
Modeling Bioreactor Performance
Effective models can, however, provide guidance to minimize the number of required experimental runs and reduce risks. On the other hand, modeling is less appropriate when the model is unable to hold …