by jhscmo | Jan 16, 2025 | Case Studies
Challenge A customer came to our team at JHS to fill GMP (Good Manufacturing Practices) batches to submit a new drug (NDA) of an ophthalmic ointment within a highly expedited timeline. The customer needed two clinical batches and three registration batches within a...
by jhscmo | Jan 13, 2025 | Articles
What are some of the biggest changes CMOs and their partners will see in 2025? We discuss developments in Annex 1 compliance, the BioSecure Act, AI drug development, supply chain challenges amid new tariffs, and pandemic preparedness strategies. 1. Annex 1 Continues...
by jhscmo | Jan 7, 2025 | Articles
The process of lyophilization, or the freeze-drying of pharmaceutical products including biologics/biological products, has been used in the food and pharmaceutical industries to preserve and stabilize drugs since the 1940’s. For over 80 years, lyophilization has...
by jhscmo | Jan 7, 2025 | Articles
A Step-by-Step Breakdown Preparation and Sterilization of Components: All components, including vials, stoppers, and caps, undergo rigorous cleaning and sterilization processes to eliminate any potential contaminants. Aseptic Filling Process: The sterile drug product...
by jhscmo | Jul 29, 2024 | Articles
A Step-by-Step Breakdown Preparation and Sterilization of Components: All components, including vials, stoppers, and caps, undergo rigorous cleaning and sterilization processes to eliminate any potential contaminants. Aseptic Filling Process: The sterile drug product...
