Newsletter | May 26, 2023

05.26.23 -- All You Need To Know About Contamination Control Strategies, Part 1

 
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

Fc-fusion Cell Line Development: Expression And Analytical Solutions

Understand high titer expression of Fc-fusion proteins using the Apollo™ X platform coupled with integrated quality assessments, enhancing support for clients through the predicted growth in Fc-fusion clinical applications.

Evaluating Antibody Stability With Nano Differential Scanning Calorimetry

Explore why Nano differential scanning calorimetery (DSC) is one of the best ways of measuring antibody stability with minimal sample preparation and consumption and is a possible alternative to Raman spectroscopy.

3 Steps To Optimize The Fed-Batch Process For mAb Production

We describe a straightforward way to achieve a high-performing fed-batch process for a knockout cell line. This workflow improved titers 500% compared with CHO cell culture in basal medium.

High-Throughput Preformulation Development Platform For Biologics

A high-throughput formulation development for sample preparation and sample analysis enabled a simple and less labor intensive screening of a broad range of conditions in considerably less time.

Purification Processes For Bispecifics Using Affinity Capture

Learn more about a process for the purification of BsAbs utilizing affinity chromatography followed by two polishing steps to eliminate undesirable homodimers and other impurities.

Meet The Experts: PAT, Raman Spectroscopy, And Chemometrics

Gain a better understanding of process analytical technology (PAT), Raman spectroscopy, chemometrics, and Raman applications in bioprocessing.

How Your Stainless-Steel Column Is Like A French Press

Understanding how purification columns work can help operators better conceptualize the process, enabling greater process understanding and troubleshooting.

Is Your Biologic At Risk For Protein Aggregation? Part 2

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologic drugs. We offer steps you can take to help prevent aggregation.

Contamination Control Technologies And Minimizing Filter Plugging

Learn about the three most common sources of filtration failures and how to prevent these problems.

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