Our Approach

At Pharmatek, we understand that every peptide project is unique. With more than 40 years of combined experience working with a variety of peptides, Pharmatek’s scientists bring the skills and know-how to tackle some of the most difficult peptide development challenges. Our customized, knowledge-based approach to peptide projects ensures a smoother journey from the bench to the clinic.

Our Peptide Experience Includes:

•Non-Specific Binding
•Aggregation
•Hygroscopicity
•Instability of Liquid Formulations
•Complex HPLC Traces & Need for Method Orthogonality
•Compound Sparing Approach to Development

We base our approach to formulation and analytics on the physical and chemical properties of each peptide and have built a robust development program that will meet IND requirements and generate meaningful stability data.

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Capabilities

  • Orthogonal Method Development
    • Reversed Phase
    • Ion-Exchange
    • Size Exclusion
  • Plasma Compatibility Studies
  • Accelerated Studies w/Arrhenius Prediction
  • Working Reference Standard Programs
  • In-Use Hygroscopicity
  • Adsorption Studies
  • Stability in Dosing Configurations
  • Lyophilization
  • UV Spectrophotometry (Turbidity, Assay)
  • EP Clarity

CMC Expertise

  • Chemistry & Sequence Driven Analytical Methods Development & Management
  • Tox Formulation Development & GLP Support
  • Phase Appropriate Formulation Strategy
  • In-Use Stability Considerations
  • Lyophilized Process Development & Scale-Up Considerations
  • Phase Appropriate Optimized Manufacturability
  • Tech Transfer
  • Fill Finish Network