The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion. The meetings focus on relevant CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and regulatory interactions. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. Outcomes of the Forum meetings are published in an appropriate peer-reviewed journal. It is envisioned that these outcomes will help assure that biopharmaceutical products manufactured in a regulated environment will continue to be safe and efficacious.
In vaccine development and manufacturing, GE Healthcare provides a suite of scalable solutions from cell culture through purification to analysis, which offer flexibility and economy, improve purity and secure quality.
Register to download these two NEW application notes:
Microcarriers and disposable bioreactors for MDCK and Vero cell culture
Secure cell propagation with adherent cells at reduced cost and with increased flexibility
DNA removal from influenza virus culture
HTPD and DoE for development and optimization of a chromatography step for the removal of host cell derived genomic DNA
Practical Considerations for DoE Implementation in Quality By Design
Contractor Responsibilities in Outsourced Pharmaceutical Quality Control Testing
Measuring Manufacturing Cost and Its Impact on Organizations
Single-Use Technology
Fluorescence-Activated Cell Sorting for CGMP Processing of Therapeutic Cells
The Roles of Bioactivity Assays in Lot Release and Stability Testing