Search results for " report" in Articles / App Notes
Article
Biosimilars: Making the Switch Comes with Challenges
The issue of variability
A drive was initiated to reassure doctors and patients including a pharmacovigilance action programme to encourage reporting of adverse effects, communications with patien…
Article
Continuous Processing for the Production of Biopharmaceuticals
In recent years, there have been publications reporting development of a fully integrated end-to-end commercial continuous process for the manufacturing of recombinant monoclonal antibodies (5).
T…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The citric saline method (4) has also been reported as a very gentle treatment for cell detachment. Non-enzymatic chemical treatment provides a gentle cell-detachment method. Besides poor spatial and …
Article
mAbs to Watch in 2016
As such, there may be products that are filed or in Phase III that are not included in these reports, due to the lack of information regarding approval/launch dates from either of these sources. Simil…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
We report on a new integrated platform for automated harvesting of whole unclarified cell-culture broths, followed by in-line tandem affinity-capture, pH neutralization and size-exclusion chromatograp…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
What’s In a Name? For Biosimilars, A Lot
It has been reported that FDA determined that the United States Pharmacopeial Convention’s (USP’s) monograph for filgrastim does not apply to the first-ever approved biosimilar product, Zarxio (filgra…
Article
A Bright Future for the Plasma Fractionation Industry
Improvements in more established process operations, such as filter press operation and chromatography processes, were also reported.
Among the quality and regulatory trends, Quality-by-Design (…
Article
Use of Multivariate Data Analysis in Bioprocessing
The authors reported the application of PCA identified causes for batch deviations and revealed process differences between the 2-L and 10-L batches that were previously considered comparable.
For…