Extractables and leachables (E&L) studies are an essential component of regulatory filing to demonstrate product safety. Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks associated with the final product.
By understanding the pitfalls that impede early development, risks can be effectively managed, helping your program and organization achieve long-term commercial success. Examine 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.
Through strategic partnerships and outsourcing strategies, pharmaceutical and biotech companies are enabling acceleration through collaboration. As we look to the future of drug development, a panel comprising consultants and early development experts explores new short- and long-term CDMO and supply chain strategies.
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.
Consider the benefits of partnering with a CDMO to conduct risk assessments, provide trained staff to supplement your existing environmental monitoring program, and support your routine environmental monitoring needs. Learn how the right partner can ensure your facilities maintain cGMP compliance and help establish the correct testing program and parameters.
