In a recent roundtable discussion, a panel of product development experts with diverse perspectives examined the blind spots that can plague an early development strategy, as well as which considerations must be accounted for when navigating the path toward an IND submission. Learn more about the advice they have to offer based on their experience and expertise.
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. Choosing the right CDMO can make or break the ability to deliver swift modifications to a formulation.
Manufacturers must ensure microbial control in the production environment through environmental monitoring, microbial identification and trending, and the use of proven and continually updated cleaning/disinfectant protocols. These steps must be taken to maintain compliance with regulatory intended to assure the quality of drugs and medical devices and thus patient safety.
When preparing for IND submission, drug developers must carefully consider multiple components of their program: analytical challenges, manufacturing and engineering controls, delivery systems, and more. Explore tips for optimizing your early development program and the benefits of housing all related activities under one roof.
Cambrex offers method optimization to take early-stage development methods with poor stability indication, excessive run time lengths, or legacy column chemistries and modify them, where desirable, to shorten run times, improve peak shape, confirm specificity, and enable determination of LOD/LOQ.
