Search results for " process characterization" in Articles / App Notes
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Understanding Validation and Technical Transfer, Part 3
Process and analytical development includes validation master planning, process characterization, and process parameter criticality assessment and classification. During the implementation and commerc…
Article
Being Thorough When Transferring Technology
This becomes invaluable to others later, and helps support claims for process characterization and robustness; selection of control and critical parameters; and setting of specifications. A summary of…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Prior to process characterization experiments, this risk assessment may be more high level using primarily prior knowledge and scientific principles. However, a more formal FEMCA may also be considere…
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
Mapping a Route for Cell and Gene Therapy Process Development
… high-quality materials generated by qualified vendors are not available
- A lack of adequate process characterization tools and technologies.
Many of these challenges apply to the deve…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The purpose of this assessment is to provide a focus for the downstream process characterization work required to complete process validation Stage 1 (process design).
This initial risk assessm…
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 for biotechnology products—part 1
This knowledge is gained during development and grows with more manufacturing experience through process characterization, scale-up, technology transfer, and manufacture, as well as through increased …