Search results for " knowledge"
Article
Efforts Accelerate to Streamline Postapproval Change Process
While changes in an EC normally would require a regulatory submission, a firm able to demonstrate greater product and process knowledge may justify reduced reporting. If the industry gets ECs right, R…
Article
Modeling Bioreactor Performance
He also notes that multivariate data analysis packages can transform at-line/online/near-line data into process knowledge, particularly the prediction of batch trajectories and outcomes in real time. …
Article
Process Chromatography Selection for Downstream Processing Applications
In order to address bioburden, one needs good sanitization methods and knowledge about likely species present in the local environment. Techniques such as closed column packing and/or the use of pre-s…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
Further, if they’re to maintain expertise in bioprocessing, they need to have a fuller ‘toolbox’ of options, innovation, and knowledge at their disposal than other manufacturers who may need to build …
Article
Analysis of Glycosylation in Biosimilars
It is still not definitive--whether a N-acetylhexosamine is N-acetylglucosamine or N-acetylgalactosamine is not clear, for example--but knowledge already built up about the biosynthetic pathway can be…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Maintain solid knowledge of raw materials origin, sourcing, manufacturing, testing, storage, and traceability.
• Review of critical raw material specifications for adequacy and viral saf…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…
Article
Antibody Purification Handbook
Access the Knowledge Center and download the Handbook.
Article
GMP Challenges for Advanced Therapy Medicinal Products
“[Our own data] has consistently shown that GMP manufacturing knowledge remains a barrier for academic triallists aiming to perform the full cycle from preclinical investigations to early and subseque…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Using the peaks (masses) of the spectrometric analysis, in combination with the knowledge of the N-glycan, the core structure, and the biosynthetic pathways that are present, it is possible to arrive …