At the heart of a culture of quality is the desire to continually improve. From the use of digital tools to increase efficiency to innovating a leading brand to tackle tough customer challenges, Nutrition & Biosciences continues to enhance the solutions it provides to customers, including the quality of its excipients.
Decades of producing our quality excipient chemistries have led us to continually deliver product quality on a reliable, consistent basis. This expertise allows us to understand how even slight process modifications can impact product performance. Digital tools can now analyze thousands of data points daily to optimize our processes and ensure better products.
We utilize the power of Advanced Analytics tools to tap into the huge amount of data generated throughout the production process. This analysis delivers new insights to address variability throughout the manufacturing chain, resulting in even more stable processes, fewer supply disruptions, and even greater batch to batch consistency – all within strict validated parameters.
Digital models of our processes allow us to better evaluate the impact of many production factors—from raw materials to reaction parameters and more. This data output is tracked on dashboards to monitor how the aspects of production can run under optimal conditions. Our well-established management of change systems ensure that manufacturing changes follow stringent cGMP and International Pharmaceutical Excipients Council (IPEC) guidelines.
Technically unavoidable particles (TUPs per the IPEC 2015 guidelines) have presented challenges for pharmaceutical customers and excipient suppliers. Many customers and suppliers are confronted by the inherent variability of standard testing and the lack of a common measurement method across the industry.
Most excipient suppliers have struggled to make the reduction of TUPs in their dosage forms actionable. Until now. Nutrition & Biosciences is proud that its Avicel® microcrystalline cellulose (MCC) brand, known for exceptional quality and performance, has a lower TUP profile with its Avicel® LS product range. The range can help reduce the concerns caused by TUPs.
More than that, Nutrition & Biosciences is using digital expertise to predict the probability of TUPs showing up on the surface of a tablet or capsule.
This short video shows our TUPs Calculator™ in action- An app that takes key quality parameters and converts them into statistical probabilities. It allows pharmaceutical customers to understand tablet surface visible speck probability on MCC Speck count, Tablet geometry and MCC concentration.