Newsletter | September 7, 2023

09.07.23 -- FDA Approves First Biosimilar To Treat MS


Key Considerations In Selecting A Robotic Solution For Endotoxin Testing

The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

Agile Software Development In Bio/Pharma & Medical Devices, Part 2

Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.


Regulatory Considerations For Alternative Microbial Methods

We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.

How Buffer pH And NaCl Affect Size Exclusion Chromatography

Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.


Boehringer’s Cyltezo Illustrates Intersection Of Price And Regulation In Biosimilar Market, Says GlobalData

FDA Approves First Biosimilar To Treat Multiple Sclerosis

Alvotech And Bioventure Announce Approval Of AVT02 (Adalimumab) In Egypt


Analytical Labs Particle Analysis


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