The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
The author outlines key functional attributes to assess a small-scale model.
The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.
The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.
The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
FDA issued a warning letter to College Pharmacy for multiple violations.
The agency sent a warning letter to Cape Apothecary for adulterated drugs.