Whitepapers

Patrick Lavery is an Editor for the MJH Life Sciences brands Pharmaceutical Technology and BioPharm International, and their respective websites, 

. He previously spent nearly a decade as a news anchor, reporter, and producer at New Jersey 101.5 FM.

Articles

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

Mitigation of US Pharma Supply Chain Risk is Goal of New NIPTE Strategy

Octet® BLI systems reduces CQA assay development and run time enabling fast and efficient analysis. Learn how BLI is utilized across a range of CQA applications.     

Rapid Monitoring of Critical Quality Attributes Using Octet® BLI

The 5’ capping is a CQA for mRNA vaccines and therapeutics, and needs to be fully characterized. Learn a sensitive, robust LC-HRAM-MS/MS method for identification and quantitation of 5’ cap.

mRNA 5’ cap characterization using LC-HRAM-MS

In this case study we use a model protein formulation containing silicone oil microdroplets to show how flow imaging microscopy with FlowCam can help analyze particles in biotherapeutic samples.

Characterization of Protein Aggregates and Other Particles in Biopharmaceuticals

Cold Chain Logistics

Using AI for CAPA and Root Cause Investigation

The Sartorius-developed software, the Extractables Simulator, allows flexible combination of multiple component extractables data and prediction to facilitate the use of single-use systems in critical processing operations.

ExSim: Simplifying E&L Through in-Silico Modeling

Characterizing Proteins by Intact and Subunit Reversed-Phase HPLC: Practical Method Development Strategies

-Higher integrity assurance is needed for single-use systems
-An integrity-testing strategy may be required to meet regulatory expectations
-New scientific and technological approaches offer stronger integrity



Single-Use System Integrity

Download this application note to learn about hazardous drugs basics - listing through storage, engineering controls and training programs, and why you shouldn’t wait, regardless of initial enforcement for your facility.

Quality Whitepapers