Search results for " control"
Article
Achieving Process Balance with Perfusion Bioreactors
“The most specific need is that the cell retention device and system to control the perfusion recirculation flow, cell bleed, and product-containing flow must be integrated with the bioreactor effecti…
Article
Tools for Continuous Bioprocessing Development
• Bioreactors themselves, which control this large number of parameters, are large, complex to operate, and have not been standardized.
• Standardization is hampered by use of various platforms and…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The common factor across all of these considerations is the need for better process understanding and control to ensure that quality objectives are met.
Advances in analytical instruments are one …
Article
Understanding Validation and Technical Transfer, Part 3
If controlled environments are necessary, validation studies should demonstrate their suitability.
Processing, holding, and expiration periods should be evaluated and established to ensure prod…
Article
Reconciling Sensor Communication Gaps
For most of the history of the biomanufacture of therapeutic proteins, in-process measurement and control focused on upstream operations. Historically, cell culture and fermentation persist longest am…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
Article
Evaluating the Use of Continuous Chromatography
In addition, continuous processing intensifies production and lowers capital costs, while enabling better control (1).
Although significant strides have been made to advance continuous upstream pr…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of paramet…
Article
Being Thorough When Transferring Technology
This requires an understanding of what the rate limiting or controlling phenomena are and at each scale. What is limiting or rate controlling at the small scale often is not at the large scale. That i…
Article
Continued Process Verification for Biopharma Manufacturing
Some elements of CPV overlap with existing GMP systems such as the generation of data for batch release (BR) decisions, annual product review (APR), and change control.
In general, the nature and …