To get your compound into a clinical trial, a stable drug product needs to be produced. For this, several development activities need to be performed and we will help you in setting these up at our qualified partners:

Formulation development

A formulation suitable for administration to patients needs to be developed. This formulation needs to be such that the API remains stable during storage.

Analytical method development and validation for its intended use

Methods to analyze the drug product (i.e. concentration, purity, pH, etc.) are to be developed and validated for their intended use. OctoRelease will make sure that the validation of the method will be done phase appropriate.

Stability Studies: Assessing the Durability of the Drug Product

Stability studies are crucial to determine the shelf life of your drug product under various storage conditions. OctoRelease’s team evaluate the stability of your formulation over time, ensuring that it maintains its potency, purity, and safety throughout the duration of the clinical trial and beyond. Our commitment to stability testing ensures that your drug product is safe and effective for patient use.

OctoRelease: Your Comprehensive Partner for Stable Drug Product Development

With OctoRelease as your partner, you can rest assured that your drug product development journey is in expert hands, from formulation development to analytical method validation and stability studies. Our team is committed to providing you with the knowledge, guidance, and support you need to successfully produce a stable drug product that meets the highest quality standards and regulatory requirements.

Partner with OctoRelease and embark on a journey towards a stable drug product that empowers you to bring breakthrough therapies to patients.