Overcoming Limitations To Achieve Uniform Dosing

By Tracy Milburn, Director, Analytical Services, Cambrex

Drug companies often consider the value of CDMOs in terms of process development to meet milestones for regulatory filings and scale-up efforts for commercialization. However, specific needs in the clinic can also drive new efforts in method development and drug product formulation. Choosing the right CDMO with the proper experience and facilities can make or break the ability to deliver swift modifications to a formulation.

Formulations of low-dose drugs require a careful balance of several factors to ensure that each dosage has an acceptable blend and content uniformity. Determining the right methods and equipment specifications to pair with the selected material requires expertise across multiple areas of the development process. In this case, an immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery. With the equipment already optimized to deliver the smallest dose, Cambrex targeted modifications to the formulation to solve the client’s needs. The analytical team worked on multiple fronts while also supporting the manufacturing team, and delivered qualified methods to support release testing of batches of the new formulation.