Search results for " analytical methods"
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Refer to Figure 4 to compare rinsing results with various analytical methods for monitoring components within a formulated cleaning agent (13).
Figure 4. Monitoring of cleaning agent …
Article
Elucidating Biosimilars Characterization
…reafter) about the importance of characterization studies during biosimilars development and related analytical methods.
The complex nature of biosimilars
BioPharm: Why are biosimilars…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
One consequence of this emphasis on speed is increased demand for more efficient development and validation of faster analytical methods. Rapid inline or online methods that can provide results within…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Late-stage development starts with set up and validation of analytical methods and with securing reagents (8–10) for the analytical program. A broad range (50–60 variants) of different analytical tech…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
Article
Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration.
By Cynthia A. Challener
jijomathai/stock.Adobe.comAnalytical instrument…