Search results for "process verification"
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Being Thorough When Transferring Technology
In judging the success of transfers, having historical data compiled from the process using a continued process verification solution that pulls quality control and batch record data will enable easy …
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
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…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
This limitation frequently is one of the primary drivers of establishing the continuous process verification (CPV) program in Stage 3 to monitor the future impact from this raw material variation. For…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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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
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
This model separates the various steps and activities of validation into three stages: process design, process qualification, and continuous process verification. Since then, the lifecycle model has b…