Manufacturing Troubleshooting
Manufacturing Troubleshooting
We are experts in the science underpinning formulation development and manufacturing processes. Our focus and expertise on research and development makes us uniquely capable of troubleshooting problems related to manufacturing processes at any scale. Typically, pure play CMOs may not have the required R&D mindset or capability to perform troubleshooting, which results in significant expenses and delays for clients.
We have experience with a variety of commonly occurring problems related to manufacturing process tech transfer and scale-up:
- Content uniformity of failure of low-dose drugs during scale up to 75 cubic foot dry powder blender
- Weight variations due to poor flow of powders observed in high-speed presses
- Root cause investigation and remediation of lack of uniformity during packaging operation for a pharmaceutical suspension product
- Dissolution failure during large scale manufacturing of coated multi particulate coated bead products
- Tablet capping upon scaling up to high-speed tablet press
- Stability failure due to formation of related substances when changing injection filling line
- Nitrosamine impurity remediation observed due to nitrite contamination in API
- Addressing gross content failure on commercial production
- Qualifying alternate API sources and remediating manufacturing failures that occur due to change in API source
- Solving dissolution specification failure through application of level 1 SUPAC changes with minimal regulatory impact
Our focus and expertise on research and development
makes us unique.
Our qualified formulation and process engineer scientists travel globally to the manufacturing location to understand the problem first-hand and to build a product working relationship with engineers, operators, and management at the CMO. We will then implement our experience and knowledge during our technical troubleshooting process review to ensure that your project stays on track and your commercial product stays on the market.