At any stage of product development, Quotient Sciences optimizes your dosage forms to improve their release profile, to make them suitable for further development and commercialization and to tailor them for a specific population or age group.
“Due to the low density and poor flow characteristics of our drug substance, we experienced significant blend and content uniformity issues. By transferring our program to Quotient, the development team was able to quickly produce demo batches through multiple blending steps and roller compaction using the Gerteis Mini-Pactor. The increase in drug load from 25% to 40% was a significant improvement as we prepared for future Phase II/III trials and this ultimately benefits the patients by reducing the pill burden. We have successfully manufactured several GMP batches of tablets at various doses using a common blend. Quotient is an outstanding development partner with a no-nonsense approach, excellent communication, speed and robust easy to review documentation from analytical methods to master batch records”.
Sean Premeau, Director, CMC at Amplyx Pharmaceuticals