Search results for "analytical" in Articles / App Notes
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Advances in analytical instruments are one key part of the solution. Novel techniques including Raman spectroscopy and other advanced monitoring methods have the potential to reduce the reliance on di…
Article
Methods Accelerate Biosimilar Analysis
In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…
Article
Evaluating E&L Studies for Single-Use Systems
Analytical methods
In the three case studies, the following analytics were applied:
• Headspace sampling/gas chromatography/mass spectrometry (HS/GC/MS) and gas chromatography/mass…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The developed testing algorithm, which incorporates a combination of few relatively simple analytical methods such as osmolality, quantitation of glucose, and folic acid, provides specific identity co…
Article
Virus-like Particles as Therapeutic Moieties of the Future
In this 44th article in the “Elements of Biopharmaceutical Production” series, the authors review the status of VLPs as therapeutics as well as challenges associated with their analytical and function…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities and their consequence to the ultimate quality, safety, and efficacy of biopharmaceuticals--as well as improvements in analytical technology that provide…
Article
Witnessing Major Growth in Next-Generation Antibodies
Additional analytical and regulatory demands
Next-generation antibodies also have their own set of analytical and regulatory challenges. With respect to analytical methods, each format/target comb…
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
Article
Using Multiple Techniques in Biosimilar Analysis
Whether they are called ‘sameness’ for generic drugs, ‘comparability’ for biologics, or ‘analytical similarity’ for biosimilars, these tests are crucial for any regulatory submission, which is vital t…
Article
Leveraging Data for Better Biopharmaceutical Process Control
For many years, though, extending this approach into true process analytical technology (PAT) and using it to track and control processes was done mainly in the research lab.
Recently, there ha…