Newsletter | April 8, 2024

04.08.24 -- What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production

FOCUS ON UPSTREAM MANUFACTURING

What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production

Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks. 

 

Metabolite Analysis In Cell Therapy Development

Understand the importance of metabolic analysis in cell therapy, optimizing cell culture media formulations, and enhancing the effectiveness of CAR T-cell therapy and stem cell transplantation.

 

Robust CHO Cell Expression Platform For High-Quality Biomanufacturing

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

 

Time To Think Globally With Locally Acting Anti-Fibrotic Therapies

Take a look at important information and data from PubMed publications regarding cancer and fibrosis research as well as learn about MSCs and their EVs/Exosomes.

 

Cell Line Development For Multichain Biologics

Explore a platform used in creating CHO cell lines for manufacturing multichain biologics in a presentation that emphasizes the uniformity of pools this platform generates.

 

A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale

As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

 

Optimized Performance And Fast Bioreactor Setup

Make life in the lab easier with single-use bioreactors that provide a smooth setup and workflow, as well as 3D printing technology that customizes the bioreactor to your application.

 

Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies

In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.

 

Advances In High-Throughput Upstream Process Development

Explore temperature effects on product titer, automated cell culture development workflow, maximizing product life cycle efficiency with the right DOE strategy, and effective data management.

UPSTREAM MANUFACTURING SOLUTIONS

Advanced Tubing Retainers: Pharma+ - Nordson MEDICAL

Supplemental Bioreactor Capacity Accelerates Bioprocess Development - Culture Biosciences

Improving CLD Efficiency With An Innovative Platform - Abzena

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