Considerations For Complex Formulations – How To Simplify Your Outsourcing

A well-established technology transfer, process development, scale up and formulation is key to positioning a successful clinical trial preparation. While technology transfers can be a challenge with any drug product, even greater vigilance is needed with more complex formulations such as lipid nanoparticle-based (LNPs) drugs. These complex formulations have structural similarities to naturally occurring biological vehicles; as a result, they are generally well tolerated by the body. Therefore, LNPs are increasingly being used to deliver highly specialized therapeutics molecules, such as oligonucleotides, which are seeing increased attention in drug development due to their ability to tackle disease on the genetic level. But, these formulations are inherently complex and require a more comprehensive manufacturing and testing approach.

Despite the growing body of research and scientific knowledge, perhaps the biggest challenge with LNP formulation is the journey into the unknown. The stability profile of the finished formulation is very dependent on lipid selection and the manufacturing process. Many involve novel payloads or APIs, and interactions between the various compendial raw materials are not fully understood. The supply chain requires careful and collaborative scheduling, and as such, a successful tech transfer will often rely on parallel transfer and development efforts at raw material suppliers. The development of an LNP-formulated drug product can be a daunting task unless one has preliminary data to work with or previous experience with lipids.

Getting the final drug product to the clinic—and eventually over the finish line of final approval—is very much a team effort. In this webinar, the subject matter experts at Aji Bio-Pharma, which has manufactured over 400 non-GMP and GMP batches of liposomal, nano-suspension and LNP products, share the necessary development and manufacturing considerations for a smooth tech transfer. They will explore these challenges in depth and discuss the questions you should be asking your manufacturer.