November 22nd 2024
With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.
November 21st 2024
Current Trends in Host Cell Protein Detection for Biologics Manufacturing
February 1st 2023In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Safeguarding Biologics— Blending Engineering Ingenuity and Managerial Excellence
January 1st 2023Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.