As polymers of amino acids, peptides are neither small molecules nor large biologics. Peptides are typically water soluble, hydrophilic, and charged, so they are poorly absorbed across the skin and mucosal membranes. Historically, peptides have mainly been administered via injection, but with recent advancements in enabling formulation technologies, alternative routes of delivery, such as oral dosage forms, are becoming more prevalent.
At Quotient Sciences, we understand that each peptide is unique, and that there is no “one-size-fits-all” approach to formulation design. With over 30 years of experience working on a variety of peptide programs for a range of delivery routes, our scientists are skilled at developing strategies to reduce degradation and instability while maximizing absorption and bioavailability.
Our approach to formulation development is based on the physical, chemical, and biopharmaceutic properties of each peptide, and we build robust, fit-for-purpose early development programs that meet Investigational New Drug Application (IND) and other regulatory requirements.
At Quotient Sciences, we offer standalone or fully integrated drug product development and clinical testing services for peptide programs. With development and manufacturing services spanning the entire development pathway, we can support your program from candidate selection to commercial launch.
In this phase, we develop an experimental plan that is tailored to the stage of development and the availability and purity of your drug substance, often using material-sparing approaches. This enables us to recommend a lead molecule and a drug delivery strategy to pursue for in-vivo animal studies.
We can support:
Peptides often present unique stability and permeability challenges, so we provide a well-designed and adaptive plan for pre-clinical in-vivo screening and safety assessments.
Our expertise includes:
The clinical performance of a peptide can deviate from the outcome predicted by pre-clinical data. For non-parenteral routes, such as oral and nasal delivery, a complex formulation approach may be required for the FIH trial.
Our scientists are experienced with:
At Quotient Sciences, our unique Translational Pharmaceutics® platform accelerates peptide development by integrating formulation development, real-time adaptive manufacturing, and clinical testing, all under one organization and a single program manager. Flexible study protocols and rapid ‘make-test’ cycles enable formulation optimization in real time based on arising clinical data, which reduces development risks, maximizes the probability of success, and saves time and costs.
Key applications include:
Our webinar, "Accelerating Peptide Development: Strategies to optimize the formulation and manufacture of peptide therapeutics," 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.
Client case study
Stealth BioTherapeutics had already developed an IV formulation of their peptide drug target, and they asked Quotient Sciences to develop a SC formulation to enable patient self-administration for a different indication. It was important to ensure the tolerability of the formulation while achieving similar PK parameters. Using the Translational Pharmaceutics platform, Quotient Sciences developed a formulation design space to enable flexibility to adjust both the dose and volume of injection administered to healthy volunteers, with decisions about what would be dosed in the next dosing period informed by the PK and tolerability data from the previous dosing period. As a result, a SC formulation that was well tolerated and hit the required target PK parameters was identified in less than 7 months.