Peptide Drug Development
Accelerate the development of your peptide therapeutic drug product.
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.
About Peptides
Due to their high selectivity and potency, peptide drug products are a rapidly growing area within the pharmaceutical industry for oncology, metabolic disease, and rare and orphan indications. The complexity and unique physicochemical properties of peptides present many challenges to drug developers.
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.
Experts in formulation development
Quotient Sciences' 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.
- Peptide characterization and pre-formulation
- Biopharmaceutics profiling to guide route of delivery and formulation strategy
- Pre-clinical and clinical formulation development and optimization
- Phase I clinical assessment in healthy volunteers
Dosage forms for a variety of delivery routes
- Oral, including regional delivery
- Parenteral, including intravenous (IV), subcutaneous (SC), and intramuscular (IM)
- Inhaled
- Nasal
- Topical
- Rectal
- Vaginal
Clinical testing capabilities
- First-in-human (FIH) studies
- Relative bioavailability studies to optimize drug delivery technology performance
- Absolute bioavailability studies
- Bioanalysis
Candidate development
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:
- Analytical development using appropriate techniques
- Liquid chromatography with mass spectrometry (LC-MS)
- Reversed-phase high-performance liquid chromatography (HPLC)/ultra-performance liquid chromatography (UPLC) with ultraviolet (UV), size-exclusion, and charged aerosol detection
- Light scattering methods
- Chemical stabilization (solid and solution state)
- Assessment of aggregation and binding
- Characterization in biorelevant conditions
- In-vitro permeability assessment
- Bioanalysis
Pre-clinical development
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:
- Solution development for oral and IV dosing
- Animal model selection appropriate for the drug delivery strategy
- Permeability enhancement by use of excipients and targeted drug delivery
- Safety assessment and dose selection of permeation enhancers
Clinical development
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:
- Formulation design for a wide range of FIH dosage forms
- Adaptive clinical trial design solutions that allow dose strength and/or functional excipient selection based on emerging pharmacokinetic (PK) data
- Use of controlled-release coatings and permeation-enhancing excipients for oral, nasal, and other non-parenteral formulations
- Imaging using gamma scintigraphy to evaluate dosage form performance in the gastrointestinal (GI) tract
- Sterile manufacturing of peptide products for IV, SC, and IM injection
Integrated strategies to accelerate peptide development
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:
- Accelerating molecules from FIH to proof of concept (POC)
- Selecting and optimizing clinical formulations
- Optimizing formulations to minimize injection site reactions
- Managing route switches from parenteral to alternative routes such as oral delivery
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Info SheetPeptide Development StrategiesPeptide drug products continue to gain popularity in the pharmaceutical industry due to their high selectivity, high potency, and good safety profile. However, formulating peptides can present many challenges for drug developers because of their unique physicochemical properties.
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Peer Reviewed PublicationScientific Paper_Development and approval of rybelsus (oral semaglutide): ushering in a new era in peptide deliveryDownload our latest scientific publication entitled: Development and approval of rybelsus (oral semaglutide): ushering in a new era in peptide delivery
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Case StudiesEndevica Case Study - Peptide Program using Translational PharmaceuticsEndevica Bio is developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Read how they leveraged the Quotient Sciences Translational Pharmaceutics platform for this program.
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Case StudiesEnsysce Biosciences Case StudyRequest a copy of our latest case study with Ensysce Biosciences about how our integrated strategies helped them achieve their regulatory milestones faster for PF614-MPAR, an Extended Release product.