A contract manufacturer's production of an active pharmaceutical ingredient (API) for a commercialized antibiotic was yielding poor results after approximately 20 years of production without manufacturing problems. They contacted Aptuit to determine why the API manufacturing problem was not producing consistent API and to see if a new polymorphic form was being produced.

Scientists at SSCI, an Aptuit company, decided to take a dual approach by conducting polymorph screening on the material while also investigating the crystallization process. This polymorph screening and crystallization process control clearly identified the flaw in the development process that was resulting in poor lot-to-lot API quality. SSCI scientists demonstrated that the client had multiple forms of API instead of one and that the crystallization process being used was inefficient in forming only the desired product.

Aptuit provided a manufacturing solution that resulted in clear efficiencies, which translated to less waste, reduced cost and improved production time.