Search results for "quality by design"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product safety and quality by design (QbD)
Traditionally, product safety has relied on the incorporation of three key measures into the manufacturing process: selection, testing, and viral clearan…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Along with the process lifecycle approach, other guides have been issued by FDA and the International Council for Harmonization (ICH), which include the concepts of quality by design (QbD), risk manag…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Digitalization: The Route to Biopharma 4.0
By transforming data into an intelligence-supporting decision-making tool, it is easy to realize the longstanding regulatory initiatives of process analytical technology (PAT) and quality by design (Q…
Article
Assessing Manufacturing Process Robustness
…fication of utilities and equipment
validation of analytical methods per analytical quality by design (QbD) as per ICH Q 14
utilization of cumulative data from all rel…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
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
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
Article
PDA's Technical Report for Biotech Cleaning Validation
LeBlanc
ABSTRACT
Quality by Design principles such as design space can also be applied to cleaning validation. As discussed in the recently published PDA Technical Report No. 49: Points to Consi…