Authors: Angela Holley, Business Development Director; WDPrx – Woodfield Pharmaceutical, LLC Robert A. Falconer, Principal Consultant; Falcon Pharma LLC Pharmaceutical suspensions have been around since at least the time of the writing of the Old Testament when the prophet Isaiah recommended that a ‘lump of figs’ be spread on King Hezekiah’s boil. This may have been one of the first instances where problems inherent in the making of suspensions became apparent. The monarch m...
Producing quality semi-solids literally boils down to five key physical characteristics: homogeneity, particle distribution, spreadability, grittiness and use of surfactants. If one element fails, then the entire process breaks down. Each element must be closely monitored from beginning to end and after sale to assure patients receive the correct medication in the specified concentration throughout the life of the product. Pharmaceutical manufacturing of quality semi-solid products involves spec...
WDPrx – Woodfield Pharmaceutical, LLC is a proven and reliable CMO pharma partner specializing in oral solutions, liquid solutions, suspensions and semi-solids. We increase efficiency ‘from lab to launch’ managing early stage development, R+D, technology transfer, pharmaceutical formulation and development, exhibit batches, ANDA and NDA regulatory support. Serialization Accomplished The requirements for pharmaceutical serialization compliance were completed at WDPrx last year with t...
Although they appear as synonyms in the thesaurus, the words ‘cost’ and ‘expense’ have two different meanings when referring to technology transfer in pharmaceutical contract manufacturing. A technology transfer is the process of changing manufacturers of a pharmaceutical drug product. The pharmaceutical outsourcing procedure involves thorough analysis of every phase of the current manufacturing process from raw materials sourcing and process requirements to equipment s...
The relationship between pharmaceutical manufacturers and their contract manufacturing organizations is a key factor determining successful outcomes. Several important areas should be considered during project negotiations between manufacturers and their CMO partners to maintain productive relationships that maximize positive results. These categories include dispute resolution, division of responsibilities, changes requested outside the agreement terms, regulatory compliance filing requi...
