Newsletter | June 28, 2021

06.28.21 -- New Antibody Indications & Patent Strategies

 
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Analytical Considerations For Biopharmas Approaching Commercialization

As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

Outsourcing Services: Revealing Response To A Hypothetical Question

If you were in charge of establishing a bioprocessing contract manufacturing business, which service provider attributes would you ensure your company excelled at? Here's how your peers responded.

Integrated Market Intelligence Improves Aseptic Fill/Finish Outcomes

To offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering. 

Improve Biopharma Fermentation With Innovation, Collaboration

Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.

Next-Gen Bioprocess Monitoring: Smart Data Management And Analysis

A new platform that includes digital technologies/data management, process analytical technologies, and intensified processing will drive next-generation bioprocessing.

Comparison Of Three Cell Cloning Methods

Limiting dilution cloning (LDC) has been the standard method established for generating clonal cell lines based on statistical data, but it is time-consuming and can be inefficient. 

Continuous Process Performance For 50L To 500L Single-Use Bioreactors

This study demonstrates integration of the HyPerforma Single-Use Bioreactor (S.U.B.) and how strategic enhancements to the sparger and agitation systems have revealed potential improvements.

Intensified, Improved Fed-Batch Production Process

The high-density perfusion method described here allows you to intensify your fed-batch process through reduced production duration without affecting the growth or titer profile.

Risk, Cost, Efficiency Advantages Of Closed CAR-T Manufacturing

This article explores how developing customized solutions for system closure can solve a key technical bottleneck and advance CAR-T manufacturing.

A Control System Design Challenge For ADCs

Antibody-drug conjugates (ADCs) have a complex structure from which many different impurities can arise. Learn a science-based approach to effective control strategy design for small molecule impurities in ADCs.

Is Your Biologics At Risk For Delays, Disruptions, Or Audits?

This white paper provides an in-depth analysis of some of the most common causes of delays, disruptions, and audits, along with measures some biologics manufacturers are taking to offset these challenges.

Bridging Anti-CHO HCP Antibodies

An antibody coverage comparison of polyclonal antibodies supporting the original CHO HCP ELISA Kit, 3G, F550 vs. the resupply CHO HCP ELISA Kit, 3G, F550-1.

Simplify Your Drug Delivery Supply Chain

How an integrated offering met a rare disease biopharma's drug substance, drug product, and clinical trial packaging needs and expedited time-to-clinic.

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