Search results for " identity"
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
What’s In a Name? For Biosimilars, A Lot
…tandard applies to an article,” according to presentation notes from USP, and “shared compendial identity does not necessarily imply or mandate an FDA determination of sameness or interchangeability”…
Article
Elucidating Biosimilars Characterization
Using liquid chromatography-mass spectrometry (LC-MS) methods, we can determine and confirm the primary sequence, the presence and identity of post-translational modifications and perform protein stru…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Authentication is the solution
The identity of a cell line (i.e., authentication) can be determined by comparing the genetic signature (profiling or fingerprinting) with established databases (e.g…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
“This decreased level of process and method development results in a substantial reduction in cost, and more importantly during a pandemic, the time from determination of identity and sequence of the …
Article
Nurturing Knowledge from Disparate Data Streams
Interpretation of this type of spectrum, such as comparison with a reference standard to confirm identity, requires an expert, however. “A method for plant operators to use for determining that a lot …
Article
Best Practices in Qualification of Single-Use Systems
Visual examination of containers, labels, and recording of batch numbers should help in establishing the identity of these materials. The lack of on-site testing for these materials should be justifie…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.
Jun 01, 2015
By Cynthia A. Challener
BioPharm Inte…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…
Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
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