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 specifications and production methods.
Among factors affecting successful technology transfer that must be assessed at the start of the project include packaging line trials, stability, cleaning validation and Health and Safety review.
Moving from the initial decision to engage in a technology transfer program until the manufacture of the product in the new location with reproducable quality is a complex endeavor.
Experienced CMO partners will anticipate expenses for regulatory and legal fees, API, CAPEX (costs associated with specific equipment and machinery), labor, stability studies, packaging trials, exhibit batches and analytical method transfer charges.
The expenses listed above are able to be estimated in advance with reasonable certainty. Costs, on the other hand, are unanticipated charges that affect successful results. Failure to take these potential problems into account early in the planning stage may spell disaster for the entire transfer. Costs include incorrect analytical methods, outdated documentation, poorly defined procedures and ambiguous understanding of process parameters.
Well-defined expenses clearly conveyed to all parties create efficiencies and support successful technology transfer. However, unanticipated costs generate inefficient use of time and labor delaying development, manufacturing, regulatory submissions and approval.
Pharmaceutical manufacturers engage in technology transfer with trusted contract manufacturing partners to decrease expenses and increase efficiency. Successful technology transfer projects require detailed advance planning to assess and anticipate all potential issues and avoid unnecessary program costs.
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