Services

DEVELOPMENT, TESTING, STUDIES, MANAGEMENT AND CONSULTING

The STRATUM team offers expertise in pre-formulation and peptide formulation development, lyophilization cycle development, analytical method development and qualification, method validation, quality control, stability testing, test article preparation for toxicology testing and animal studies, and other technical support needed in the development of peptide pharmaceutical and medical device products. We believe that our services will be of particular benefit to academic researchers and small companies that may not possess the capability to carry out the required development studies to enter their active pharmaceutical ingredient (API) into clinical studies. We have the resources to complete the development work required for the CMC section of an IND.   

services include:

FORMULATION DEVELOPMENT

  • Liquid Formulations of Peptides and Proteins

  • Lyophilized Formulations of Peptides and Proteins   

ANALYTICAL DEVELOPMENT

  • Method Development

  • Pre-Formulation Support

  • Analytical Support for Product   Development
     
  • Method Optimization and Transfer   

CHEMISTRY TESTING

  • Finished Goods Testing

  • Reference Standard Characterization

  • Test Method Qualification and   Validation


STABILITY STUDIES

  • Forced Degradation Studies

  • Stability Protocols and Programs

  • Real Time and Accelerated Stability

FINISH & FILL PROJECT MGMT

  • Identification of cGMP facility

  • Project Management

  • Technology transfer
     
  • Engineering runs   


PHARMACEUTICAL CONSULTING

  • Process validations

  • Method validations
     
  • Quality control