Drive efficient product development that meets regulatory standards.
GRA’s experts provide extensive support to organisations in both Formulation Development and Stability studies that ensures biopharmaceutical molecules are developed efficiently and meet regulatory standards.
Formulation strategy involves designing and developing a biopharmaceutical to ensure its safety, efficacy, and stability. Quality by Design (QbD) and Design of Experiment approaches for Formulation strategy can be applied. GRA supports key aspects of this that include:
- Pre-formulation Studies: assessing the physical and chemical properties of the drug substance to guide formulation development.
- Excipient Selection: choosing appropriate commercially viable excipients to enhance drug stability, bioavailability, and patient acceptability.
- Dosage Form Design: developing the optimal dosage form (e.g., tablets, capsules, injectables) based on the biotech molecule's properties and intended use.
- Process Development: establishing robust drug product manufacturing processes to ensure consistent product quality.
- Regulatory Strategy: advising on phase appropriate regulatory requirements and preparing documentation for regulatory submissions.
Stability studies are essential to determine the shelf life and storage conditions of a biotech molecule. These types of studies that GRA can design, support and analyse demonstrate the time that the drug maintains its efficacy, safety, and quality. Activities performed include:
- Strategic Stability Planning: designing and implementing the biotech molecule’s stability programme considering clinical phase and available batches. A living plan that is updated as changes to the process development program are introduced.
- Stability Testing: preparing protocols and managing stability studies to assess the drug's behaviour under various environmental conditions (e.g., temperature, humidity, storage position).
- Forced Degradation Studies: exposing the biopharmaceutical to extreme conditions, eg. high pH, low pH, oxidation and light, to identify potential degradation pathways and methods that are stability-indicating.
- Data Analysis and Reporting: analysing stability data trends using appropriate statistical tools to predict the shelf-life of the drug. These are summarised in comprehensive reports prepared to support compilation of regulatory submissions.
- Shelf-Life Determination: establishing the drug's shelf life based on stability data and regulatory guidelines.
- Regulatory Compliance: ensuring that stability studies comply with relevant ICH guidelines (e.g., ICH Q1A(R2), ICH Q5C).
By leveraging our expertise, GRA help clients navigate the complexities of formulation strategy and stability studies, ultimately enhancing and accelerating the likelihood of successful biopharmaceutical drug development and regulatory approval.