Newsletter | May 8, 2025

05.08.25 -- Embracing Outsourcing Quality Management In BioPharm

FEATURED EDITORIAL

The Importance Of Primary And Secondary Drying And Their Impact On Lyophilization

For parenteral formulations, biologics, and vaccines, the lyophilization process's primary and secondary drying stages require precise control of temperature, vacuum, and duration. 

Using Digital Shadows To Reinforce Downstream Modeling

This model class transfers real-time information in one direction, and it can help bridge the gap between digital model and fully functioning digital twin.

Embracing Turnkey And Outsourced Quality Management In Biopharma

In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.

Questions You And Your New CDMO Might Be Asking

One expert who has been on both sides of contracting relationships explores common questions you could — or should — be asking before signing up with a new manufacturer.

INDUSTRY INSIGHTS

Enabling Accelerated Raman Model Calibration For Real-Time Monitoring

Raman spectroscopy is a key component of a PAT strategy. Evaluate an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.

Selecting A Platform Filter For High Concentration mAbs

Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, twice the throughput.

NEWS HEADLINES

Henlius Enters Into License Agreement With Sandoz For Proposed Ipilimumab Biosimilar

CuraTeQ Biologics Receives CHMP Positive Opinion For Dazublys – Trastuzumab Biosimilar

CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code For Otulfi (ustekinumab-aauz)

Bone Health: Biocon Biologics Receives Positive CHMP Opinions For Biosimilar Denosumab In Europe