In 2017, Sharp was approached by a small virtual pharma client to manufacture an oral formulation of their new Alzheimer’s treatment. The client was specifically looking to improve on delivery timelines for the manufacture of a capsule, as they were having issues with lead time with their existing CMO.
In addition to the challenging timelines, this Phase III drug also contained two active ingredients in a single dose, which significantly increased the complexity of the manufacturing process. The client also required 8 different batches of the drug – that is 8 different product strengths – each with a batch size of 500,000 units. All methods had to be validated and the product needed one month of stability testing for the necessary FDA filing.