Pharma companies are turning to novel technologies and formulation approaches in their efforts to overcome obstacles, but these technologies must be able to adhere to GMP for both clinical and commercial manufacturing. It is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of active pharmaceutical ingredients (APIs) and dosage forms with the promise of viable clinical and commercial success.
Nanoparticle engineering is one technology emerging as an efficacious solution to development obstacles, including the growing challenge of poor aqueous solubility in new drug candidates. This leads to poor bioavailability and is a leading cause of failure in clinical candidates. Possessing GMP manufacturing capabilities in-house is critical to providing continuity for partners who wish to progress to the next stage, helping increase the uptake of nanoparticle-based innovations. Thorough characterization of the API is also essential to minimize disruption later down the line during GMP manufacturing.
Nanoform, nanoparticle medicine enabling company, has embarked on an ambitious GMP expansion project to help meet the demand for CESS®-nanoformed drugs manufactured to GMP standards for use in clinical trials. Partnering with a novel technology company that has the resources to manufacture to GMP standards in-house can help to make the transition from R&D to GMP manufacturing more seamless. Learn more about the increased potential for drug development success offered by a knowledgeable, GMP-compliant manufacturing partner.