Newsletter | May 18, 2020

05.18.20 -- The Biopharma Pitch With Leslie Williams

Featured Editorial
Industry Insights
Demystifying Extractables Testing

It's critical that anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are suited to the study goals.

Scalable Strategies For Parenteral Dosage Form Selection

Understand the strategies that can be employed at the different stages of development when choosing parenteral dosage forms.

Considerations For Upstream Biologic Development

A biologic candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.

Quality Assurance And Your CDMO

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

Parallel Fed-Batch CHO Culture On SciVario Twin

Fed-batch cultures using 1c and 3c single-use vessels controlled in parallel by a twin bioreactor control system highlight the ability to run complex processes simultaneously using variously sized vessels.

Measuring Interactions Between Fc Regions Of mAbs And Fc Receptors

It is crucial to evaluate the binding interaction of monoclonal antibodies (mAbs) with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.

Ensuring Strength And Flexibility Of Single-Use Bags In All Applications

The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.

Single-Use Technology In Frozen Bulk Drug Storage: The Cold Hard Facts

This paper addresses the challenges of bulk drug substance storage, shipping, and other factors users must consider in deciding whether and how they will adopt the technology. 

Tips For Viral Vector Production

These scalable and cost-efficient processes for GMP manufacturing environments address viral vector manufacturing challenges.

The LAL Test: Precautions When Conducting Pharmaceuticals Research

For many decades, it has been found that the most effective method for determining pyrogens in pharmaceutical samples, regardless of the form of the active substance, is the LAL test. 

Scaling The Advanced Therapy Supply Chain

This case study describes the use of dispersed storage and cold chain logistics around a central manufacturing facility to create a cost-efficient and robust supply chain.

The Path To Confidence At Every Point Of Connection

Practical information on key issues including extractable/leachable testing in components, freeze/thaw in single-use assemblies, efficiencies driven by single-use technology (SUT) advances such as genderless connectors, and more.

Outsourcing Practices And CMO Opinions

Sixty percent of outsourced manufacturing buyers say a focus on innovative treatments impacts their outsourcing practices. Half prefer large global CMOs; 40 percent prefer CMOs with specialized capabilities.

Novel Analytics To Improve Bioprocessing And Validation Guideline Review

This presentation highlights how innovative protein analysis technologies have been adopted for better comparability, release testing, and impurity monitoring to improve characterization and productivity.

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