Search results for " ICH"
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
Essentials in Establishing and Using Design Space
Conclusion
Modern ICH standards encourage design space generation in new product development. Use of design space increases product and process knowledge and reduces risk. Using a risk-based and m…
Article
PDA's Technical Report for Biotech Cleaning Validation
Therefore, consistent with ICH Q7, the cleaning of these earlier steps may not be critical for the carryover of residues to the final bulk active (5). Only a few literature references document the deg…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The underlying principles of QbD and risk management are contained in ICH Q8 (R2), Q9, and Q10 (50, 54–56).
A comprehensive case study of the application of QbD principles to the development of a m…
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
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
By: Pranav Vengsarkar and Nandu Deorkar
I…
Article
The Importance of Partnering for Bioanalytical Studies
Additionally, while still in draft form, ICH M10 Bioanalytical Method Validation guidance (3) has been a decade-long collaborative initiative of analytical sciences and regulatory agencies around the …
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
Managing Residual Impurities During Downstream Processing
Intertek has also made investments in capital and personnel to ensure that it can offer optimal solutions for elemental analysis according to ICH Q3D requirements. “Certainly, this area is one in whic…