Biosimilar App Notes & Case Studies
-
How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL
4/25/2023
A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.
-
Establishing A Robust Workflow To Identify High-Performing Clones
1/13/2023
Cell line development is a complex, labor intensive, and multistep process. Learn about a platform and host cell line that minimize the risk and timeline to develop high-performing clones.
-
Simplifying CHO Cell Line Genetic Stability Testing
4/11/2024
Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.
-
Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies
2/9/2024
In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.
-
TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
7/3/2024
This study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.
-
AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease
3/25/2024
In the production of adeno-associated virus (AAV) vectors, cell lysis involves challenges addressed through high salt concentrations and a salt-tolerant endonuclease, enhancing titer and infectivity.
-
Alkaline Stability Of Fc And VH3 Binding In Protein A Resins
5/1/2023
In this study, we looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP).
-
Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy
6/14/2024
Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.
-
Overcoming The Solubility Challenges Of Antibody-Drug Conjugates
6/3/2024
Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.
-
A Synergy Of Excellence: Partnership During Unprecedented Times
5/28/2024
Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.