Peptide-based drugs are a rapidly growing segment of the pharmaceutical industry with a current value of $40 billion per year. Currently there are more than 100 peptide drugs on the market, making up approximately 10% of all pharmaceutical marketed drugs, with the expectation that substantial growth will continue throughout the next decade. The rise in peptide-based treatments is in part due to their increased potency and target selectivity and this has fuelled growth in drugs for oncology, metabolic disease, and rare and orphan indications.
Peptides are therefore a very attractive proposition for drug developers and investors alike, however, their complexity and unique physiochemical characteristics brings about a number of challenges to consider. Peptides are neither a small molecule nor a large biologic and are polymers of amino acids. They are typically water-soluble, hydrophilic, and charged, thus making them poorly absorbed across the skin and mucosal membranes and can be challenging to formulate and deliver to their site of action. Historically, parenteral delivery was the predominant route of administration for these types of molecules, however, with recent advancements in enabling formulation technologies, alternative routes of administration, in particular oral delivery, is becoming more prevalent in the marketplace.
Despite their growing popularity & technological advancements in delivery, there is still a large gap in the number of peptide drugs that fail in development vs those that actually make it to market. Drug developers must understand that each peptide is unique, and that there is no one-size-fits-all strategy when it comes to developing these complex molecules. With a high probability of failure, it’s critical for drug developers to have a clear understanding of their molecule’s physical and chemical properties so that they can make an informed formulation strategy that will get their molecule to patients.
This webinar reviews the challenges when developing a peptide formulation, investigates the best route of delivery for your molecule, alongside looking into formulation strategies and manufacturing considerations, before exploring options for an integrated approach to accelerate peptide development.
Key Learning Objectives
- Challenges when developing a peptide formulation
- Selecting the best delivery route for your molecule
- Formulation strategies & manufacturing considerations
- Permeation enhancers and enabling technologies to overcome poor permeability & bioavailability
- Design space evaluation of formulation and process variables
- Integrated CMC-clinical strategies for accelerating peptide development
- Key case studies in early development and accelerating to proof of concept
