Research and Development
Enhancing Product Quality and Characterization in Pharmaceutical Excipient Manufacturing R&D.
At our pharmaceutical excipient manufacturing facility, we place the utmost importance on ensuring the highest quality standards for our products. To achieve this, we follow a comprehensive approach to characterizing and analysing the components involved in the manufacturing process.
We recognize the critical role of excipients in maintaining the physicochemical properties of our drug products. Hence, we conduct thorough characterization of excipients, taking into account their functionality, physic chemistry, and safety aspects. This meticulous characterization process ensures that the selected excipients are suitable for the intended formulation, facilitating process ability, compliance, and long-term stability.
In order to meet the specific requirements of our solid or liquid dosage forms, we engage in pre-formulation studies. These studies focus on determining key physicochemical properties, such as solubility at different pH levels and temperatures. Through the analysis of these properties, we gain valuable insights that enable us to optimize the formulation and enhance the overall quality of the product.
Our product development strategy emphasizes the integration of biophysical and biochemical characterization techniques. By adopting this holistic approach, we ensure that the molecule remains stable throughout its lifecycle and complies with regulatory standards. By utilizing a diverse range of characterization methods, we can effectively assess the stability of the product and develop it in accordance with the highest quality standards.
To obtain regulatory clearances and evaluate the dosage integration properties and compatibility with other substances, we conduct laboratory-scale development of our batches. This allows us to perform rigorous testing, ensuring that the product meets the necessary standards before progressing to large-scale production.
Developing our products is a critical process involving conducting pre-formulation studies tailored to address specific formulation requirements. By thoroughly investigating the physicochemical properties of the product, we are able to make informed decisions that enhance its quality and efficacy.
To ensure stability and compliance throughout the manufacturing process, we conduct extensive testing and validation of lab-scale batches. This approach ensures consistency in methods and processes during large-scale production. By implementing a detailed Technology Transfer procedure, we guarantee that the product retains its desired quality attributes during scale-up.
and Product Development Reports
Comprehensive stability studies are conducted to thoroughly evaluate the performance of our products over time. These studies encompass aspects such as formulation optimization stability and potential re-formulation of primary packaging. We generate and provide regular data as required by our clients, supporting the ongoing development of the product. This enables us to make informed decisions and continuously improve the quality of our products.