The ABC's of Formulation Development for Parenteral Drug Product Manufacturing

For many pharmaceutical and biotech companies entering preclinical and clinical studies, their formulation is still in development. While most have prepared the formulation in their own lab, developing a formulation for sterile fill finish is a different challenge requiring different information. How do you scale up your formulation? Can your product be sterile filtered? How do you maintain homogeneity in suspensions? Is the drug product compatible with the vessel and tubing selected? How soon in advance does the drug product need to be prepared for filling activities? What equipment is needed in your formulation? In this webinar, we describe how your CMO can help develop and scale-up your formulation. We will also discuss supporting studies and tests that can be performed to determine your equipment requirements and build your formulation process, and what information you will need to know before you contract with and fill finish CMO. Ready to start your fill finish project? Reach out to us today! https://berkshiresterilemanufacturing... 00:00 - Intro 01:05 - Where the work starts & goals 03:36 - What your CDMO needs to know 05:12 - Development Rule of Thumb & Challenges 06:46 - Meeting Critical Properties 13:38 - Short-term & long-term stability 16:09 - Evaluating stability 19:11 - How to improve stability 22:27 - Scaling up 23:28 - Determining equipment requirements 25:35 - Achieving sterility 29:10 - Material compatibility 30:43 - Maintaining homogeneity in suspensions 34:06 - Sensitive formulations 37:13 - Viscous formulations 40:01 - Formulation development in summary 40:50 - Transition Q&A 41:50 - Q&A 48:15 - Conclusion