Background:
The customer, a tissue processor, a company that manufactures tissue grafts and biologics from donated human musculoskeletal tissues, was utilizing a gentamicin sulfate solution, an antibiotic that inhibits the growth of a wide variety of Gram-positive and Gram-negative microorganisms, as part of their aseptic manufacturing process.
Challenge:
The gentamicin sulfate solution they had qualified for their process was manufactured as a drug for patient applications. The manufacture of this drug found themselves in a situation in which patient demand was outpacing their manufacturing which resulted in the gentamicin sulfate solution being put on allocation. The customer was not using the gentamicin sulfate solution to treat patients, but rather for further manufacturing, so they were placed at the bottom of the allocation list for receiving more solution. The customer was fortunate to maintain a safety stock of the solution; however, the allocation had depleted their safety stock putting them in a situation in which they only had enough solution to support processing for 2-3 weeks. Due to the nature of the tissues the customer works with, not processing or delaying their processing was not an option as doing so would put the gift of the donated tissue in jeopardy.
Solution:
After understanding the customers situation and their specific needs for the gentamicin sulfate solution, two solutions were developed and proposed. The first was a short term solution to address their immediate need and to prevent any disruption to their ability to process. This solution entailed providing them with the gentamicin sulfate antibiotic in powdered form, as well as with bottles of USP Sterile Water for Injection, so they could manufacture the gentamicin sulfate solution themselves in their cleanroom at the time of use. Given chemical and reagent manufacturing was not one of their core capabilities, a manufacturing procedure they could follow was compiled and provided to them. The second was a long-term solution and it was designed to provide them with a like for like solution to what they were currently purchasing and using, the one difference being what we provided wouldn’t be a drug, which wasn’t a requirement of theirs. They had simply used the drug version as that is what was readily available. This solution entailed us custom manufacturing the gentamicin sulfate solution for them so that upon receipt they would have a ready-to-use version to the solution they had been using. The same formulation was used. The same preservatives and additives were added. The same specifications were tested and met. The same fill volume was used. It was equivalent in every way that mattered to the customer. The reason for the two solutions was that the custom manufacturing process would have taken longer to get the solution manufactured and released as part of the lot release testing was USP<71> Sterility Testing which has a minimum 14 day incubation period. Only proceeding with the custom ready-to-use option would have meant the customer depleted their safety stock and their processing would have been adversely impacted. By proceeding with these two solutions we were able to address their immediate needs as well as create a more sustainable supply to best support their future needs. Both of which ensured their ability to process their tissues in order to continue to provide the world their life-saving and life enhancing tissue grafts.