Norwich's expertise in granulation processes was proven when a customer brought forth a product with a deadline for a Phase III clinical trial, but had no reliable scale-up process in-place to consistently produce robust tablets with the desired performance characteristics. Formulation and process variables were affecting the drug’s product performance and the overall compressibility was poor, producing defective tablets.
With in-house granulation and compression expertise, the Norwich team defined granulation conditions in a pilot-scale fluid bed capable of consistently producing granules with the desired compressibility and product performance characteristics. The Norwich team identified important formulation and process variables with correlated responses to critical quality attributes. The critical variables were optimized resulting in clinical supply assurance for the client. Norwich re-designed the compression tooling to effectively remove air during compression, and in an innovative move, optimized the product's stability by controlling vital process variables during the coating operation.
Norwich's thorough understanding of the operating parameters involved in fluid bed processing, with respect to controlling critical process variables, resolved the challenges presented during the initial transfer activities. The manufacturing process was optimized to mitigate product performance issues and consistently produce product meeting critical quality attributes. Development activities were completed in collaboration with the customer and within the aggressive timeline. The Phase III trial was successfully initiated, moving the product closer to regulatory filing and sparking renewed investor interest in Norwich's client.
With in-house granulation and compression expertise, the Norwich team defined granulation conditions in a pilot-scale fluid bed capable of consistently producing granules with the desired compressibility and product performance characteristics. The Norwich team identified important formulation and process variables with correlated responses to critical quality attributes. The critical variables were optimized resulting in clinical supply assurance for the client. Norwich re-designed the compression tooling to effectively remove air during compression, and in an innovative move, optimized the product's stability by controlling vital process variables during the coating operation.
Norwich's thorough understanding of the operating parameters involved in fluid bed processing, with respect to controlling critical process variables, resolved the challenges presented during the initial transfer activities. The manufacturing process was optimized to mitigate product performance issues and consistently produce product meeting critical quality attributes. Development activities were completed in collaboration with the customer and within the aggressive timeline. The Phase III trial was successfully initiated, moving the product closer to regulatory filing and sparking renewed investor interest in Norwich's client.