Search results for " reproducibility"
Article
DoE Provides Benefits, but Preparation Is Necessary
“While a formulation scientist needs to know where the most stable space for an API resides, an analytical chemist may be more interested in the variability and reproducibility of results, both of whi…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
ISO, ISO 21748:2010, Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation (Geneva, 2010).
10. ISO, ISO/IEC 17025:2005, General requir…
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.
Following the 2009 outbreak of the H1N1 pandem…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Since the PPQ is a means of confirming process reproducibility under typical production conditions, CPPs and KOP are expected to be set at their normal set points and remain within their NOR. Studies …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Techniques of measurement system analysis such as Gage repeatability and reproducibility (Gage R&R) studies are recommended because they provide information on the variability of the measurement syste…
Article
Early Communication with Regulators is Essential for SMEs
The quality data to be certified would include information on starting and raw materials, the manufacturing and characterization of the active substance, and the reproducibility of the manufacturing p…
Article
Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
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…