Biologics manufacturing and quality control (QC)
Characterization tools to support biopharmaceutical manufacturing and production
Once a biopharmaceutical product has gone through scale-up and into production, many of the same biophysical characterization approaches used throughout development and formulation have a continuing role in ensuring conformance to manufacturing and quality specifications. The adoption of a Quality by Design (QbD) approach to development, with early definition of critical quality attributes and critical processing parameters, will ensure monitoring and control of identified biophysical properties, such as aggregation.
Malvern Panalytical systems are used in troubleshooting and root cause analysis, and to monitor batch-to-batch comparability or biosimilarity.
Batch-to-batch comparability and Biosimilars
Differential Scanning Calorimetry (DSC) is used in research and development to identify biotherapeutics with good stability potential and to determine the conditions that maximize a biological product’s shelf-life. It also has a role in manufacturing, where it supports the robust demonstration of batch-to-batch comparability of any biologics, or the comparability of an innovator product with a biosimilar product.
Featured products and content
MicroCal PEAQ-DSC
Compare stability and higher order structure (HOS) as part of both regulatory approval and manufacturing processes
Using DSC to investigate the impact of oxidation on protein structure
Webinar
Characterization of biopharmaceutical stability with Differential Scanning Calorimetry: Process development and manufacturing support
Whitepaper
Using Differential Scanning Calorimetry (DSC) to optimize antibody manufacturing
Application Note
Troubleshooting and root cause analysis
An out-of-specification product requires investigation to understand the cause of the manufacturing issue and prevent any recurrence. This requires referencing the final dosage form back through the processes involved in its creation, to establish where the problem lies.
Biophysical characterization techniques play a key role in determining if and where there are issues with aggregation, for example, or in determining contamination sources.
Featured products and content
Zetasizer Ultra
Examine aggregation at various process steps
MicroCal PEAQ-DSC
Investigate HOS, binding and stability issues
OMNISEC
Study proteins and protein aggregates
Morphologi 4-ID
Use Morphologically-Directed Raman Spectroscopy (MDRS) to identify contaminants and their sources
Manufacturing biotherapeutic faster using Differential Scanning Calorimetry (DSC)
Application Note
Ten reasons protein characterization scientists should upgrade from single to multi-detector SEC
Whitepaper
Characterization of protein aggregates by Morphologically-Directed Raman Spectroscopy
Application Note
Adaptive Correlation: Better insight to the presence of aggregates
Application Note
