Peptide development

Accelerating formulation development and manufacturing of peptide drug products

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. However, 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.

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.

Solid_Oral_Dosage_Form_tablets_Capsules

Our expertise

  • 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 

Our services 

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. 

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

Vial of liquid being held by a purple gloved hand

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

Info sheet

Peptide Development Strategies

To find out more about how Quotient Sciences can support your peptide development program, take a look at our latest information sheet. 

Access info sheet

Person looking at laptop with Quotient Sciences Webinar Page on the screen

On-demand webinar

Accelerating Peptide Development

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.  

Watch webinar 

Study Volunteer sitting at a table speaking to a study professional dressed in a lab coat looking at a welcome brochure.

Client case study

Injectable route switch for peptide formulation optimization

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. 

Access case study 

Get in touch
Humanity can’t afford to wait, so neither can we.
Let’s talk.