Gallus BioPharmaceuticals Enters Agreement with Omni Bio Pharmaceutical
PTSM: Pharmaceutical Technology Sourcing and Management
Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.
Gallus BioPharmaceuticals
, a CMO, and Omni Bio Pharmaceutical, a biopharmaceutical company focused on the commercialization of alpha-1 antitrypsin (AAT), reported the finalization of a multi-stage manufacturing services agreement.
The agreement includes cell line optimization, analytical development, and manufacturing scale-up activities for Omni Bio’s AAT Fc fusion protein with the goal of providing cGMP product to support animal toxicology studies and early clinical trials of the molecule. Under the agreement, Omni Bio has selected the commercially available Chozn GS Cell line from Sigma-Aldrich’s custom manufacturing and services business unit SAFC Commercial as the expression system. In addition, SAFC will perform the cell line development and safety testing services, in conjunction with Gallus’ overall management of the process development and manufacturing services program for Omni Bio.
Source:
Gallus BioPharmaceuticals
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
