Managing Outsourcing For Complex Formulations

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 (LNP) drugs. These complex formulations have structural similarities to naturally occurring biological vehicles; consequently, they are generally well tolerated by the body. As a result, LNPs are increasingly being used to deliver highly specialized therapeutic molecules, such as oligonucleotides, which are likewise seeing increased attention in drug development due to their ability to tackle disease on the genetic level.

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.

In a recent webinar, “Considerations for Complex Formulations: How to Simplify Your Outsourcing,” experts from Ajinomoto Bio-Pharma Services explored the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls. Following the webinar, Brannon Ly, Associate Director of Technology Innovation, Ajinomoto Bio-Pharma Services, and Ron Chantung, Director, Drug Product Manufacturing, Ajinomoto Bio-Pharma Services, answered audience questions relating to Aji Bio-Pharma’s work and expertise.