Search results for " verification"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The characterization, focused on the integrity and consistency of the expression construct, consists of three aspects:
• Verification of protein coding sequence in production cells through the end…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
…, based on the level of risk, cleaning processes may be subject to different levels of validation or verification.
This article covers cleaning validation of equipment dedicated to the production…
Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
Article
Ensuring the Quality of Biologicals
These general chapters give requirements for equipment and equipment verification and instructions on how to perform a method, such as peptide mapping. Ph. Eur. monographs and general chapters for bio…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
In this approach, criticality is used as a risk-based tool to drive control strategies (Stage 1), qualification protocols (Stage 2), and continued process verification (Stage 3). Overall, a clear road…
Article
Elucidating Biosimilars Characterization
Such approaches facilitate verification of the primary sequence of the molecule, identification and characterization of post-translation modifications, especially wherein the combined use of
colli…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
Parameters that are identical for each sample, such as diafiltration endpoint and flux drop percent, can also be shown for verification of status.
R…