Formulation Development
Setting New Standards in Pharmaceuticals
Formulation Development with Quality by Design
We specialize in the development of final formulations for biologicals, biosimilars, and generic formulations. Our approach is focused on Quality by Design (QbD) principles and a thorough risk assessment process. We navigate each stage of development to ensure that our formulations meet the highest quality standards.
After several rounds of formulation development and optimization, we carefully select the most suitable formulation based on scientific justification and performance evaluation. This final selection is made to ensure that the formulation not only meets quality standards but also performs reliably in real-world applications.
Formulation Development Services
Key stage include:
- Defining Critical Quality Attributes
- Analytical Development
- Reference Product Characterization
- Comparability Exercise
- Formulation Development Based on DoE
- Final Formulation Selection and Justification
Frequently Asked Questions
How does Profarma approach formulation development?
Profarma employs a systematic approach to formulation development, starting with comprehensive preformulation studies. Our team of experts works closely with clients to select the best excipients and develop robust formulations. We use advanced technologies and methodologies to optimize and scale up the formulation for commercial production.
How does Profarma ensure the stability of formulations?
Profarma conducts extensive stability testing under various conditions to ensure that formulations remain stable and effective throughout their shelf life. We follow ICH guidelines for stability testing and provide comprehensive data to support regulatory submissions.
How does Profarma ensure reference product comparability?
Profarma conducts thorough comparative studies to ensure that the new formulation is comparable to the reference product in terms of quality, efficacy, and safety. This includes dissolution testing, bioavailability studies, and other analytical assessments to demonstrate equivalence.
How can I get started with Profarma’s formulation development services?
To begin, contact Profarma through our website or customer service line. Our team will discuss your specific needs and provide a tailored proposal for formulation development to ensure your product meets all quality, efficacy, and regulatory standards.