Search results for " analytical" in Articles / App Notes
Article
Scaling Up Novel Therapies
Bioreactor manufacturers now integrate analytical technologies such as sensors, which allow better prediction and control of changes between scales, into their products. Chromatography and filter manu…
Article
A Look into the Future of Biopharmaceutical Quality
There may also be a general reluctance to implement new analytical technologies used for testing of approved products due to potential regulatory impact with a continued reliance on established analyt…
Article
The Challenge of Disruptive Technologies in Bioprocessing
“This all helps to lower the cost of the analytical effort to be made in a GMP environment (which may be one of the largest cost after one has optimized the process itself) and the overall cost requir…
Article
Making the Move to Continuous Chromatography
Some systems come with dynamic control functionality—process analytical technology (PAT)—that enables the continuous chromatography unit operation to better adapt to changes in feed concentration (whe…
Article
Analysis of Glycosylation in Biosimilars
This leaves released, derivatized carbohydrates, which is advantageous in each of the three mass spectrometry-based analytical techniques used to determine the glycosylation pattern.
In matrix-ass…
Article
Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
Article
Ensuring the Quality of Biologicals
These individual monographs provide analytical procedures and acceptance criteria to allow demonstration that a substance or product meets the required quality standards. The monographs are based on l…
Article
Continuous Manufacturing: A Changing Processing Paradigm
An agency representative said at an International Forum and Exhibition on Process Analytical Chemistry Annual Meeting in 2012 that the on-line monitoring characteristic of continuous processing can fa…
Article
USP Publishes Monoclonal Antibody Guidelines
…olecules that would be more amenable to a “platform approach” both in terms of manufacturing and analytical development.
USP has been involved in developing quality standards for biologics as par…
Article
Labeling of Biosimilars
“The inclusion of the preclinical and clinical data [only] on the biosimilar is misleading because the assessment of biosimilarity is primarily based on extensive analytical comparisons [on quality] w…