Search results for " qualification"
Article
Continued Process Verification for Biopharma Manufacturing
In general, the nature and extent of CPV should be aligned with the outcomes of process qualification by focusing attention on aspects of processing that are most important to determining the quality …
Article
Regulatory Challenges in the QbD Paradigm
Vendor qualification, supply chain oversight, and sampling and testing plans would be reviewed during the inspection. Variability of raw materials and change management would be assessed. Current emph…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
Topic covered include:
1:38 – The typical time frame for process design and process qualification for a biopharmaceutical development program
2:10 – The driving forces for the rapid scal…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Santos, “Bioprocess Development and Qualification: PAT-Based Stage 1 and 2 Acceleration Strategies,” www. bioprocessintl.com, Feb. 6, 2020.
6. M. Beccaria and D. Cabooter, Analyst 145 (4…
Article
Reimagining Affordable Biosimilars
Other contributors to variability in manufacturing include source and qualification processes of raw materials and changes in manufacturing processes (e.g., scale, sites) (18). With the use of digital…
Article
The Importance of Partnering for Bioanalytical Studies
This requires companies having a quality system in place, regular audit of the facility, maintaining documentation, training records, instrument qualification, and so on, all of which often becomes to…
Article
Gene Therapies Push Viral Vector Production
Another manufacturing challenge in viral vector production, Murphy points out, is the development and qualification of robust analytical methods to measure product quality.
“At the present time…
Article
Monitoring and Control of Inline Dilution Processes
…ntly blend buffer constituents to the exact molecular ratio that was defined in the original process qualification at the lab scale.
For more advanced control, IC is an option, according to Ver…
Article
Emerging Therapies Test Existing Bioanalytical Methods
FDA, Guidance for Industry and FDA Staff: Biomarker Qualification: Evidentiary Framework (Rockville, MD, December 2018).
About the authors
Christina Satterwhite, PhD, is senior director, globa…