Variation in excipients and continuous manufacturing

Controlling all variables is essential for Continuous Manufacturing of drug products. Excipients like APIs have inherent variation. Therefore it is of importance to understand the implications of this variation on continuous processes and thereby to the final product. DFE Pharma is applying fundamental and mechanistic analyses to gain understanding of the potential excipient variation on final product. Using this knowledge in formulation development is essential for successful implementation.

Continuous manufacturing is an emerging technology

FDA has defined emerging technologies like 3D printing and Continuous Manufacturing to achieve continuous supply of high-quality drugs in the US. Continuous processing has a great potential to address issues of agility, flexibility, cost, and robustness in the development of pharmaceutical manufacturing processes.

Strict control of all variables is necessary for high quality output

Continuous processes require extensive control strategies that can include process analytical tools (PAT), process controls (feedback and feed forward) and real time release testing (RTRT).

Inherent variation in excipients

Excipients play a key role in the design of a robust formulation and in the development of a continuous manufacturing process of a drug product. Excipients (and APIs) have inherent variation. A better understanding of excipients, and particularly their variability and limitations is key to accommodate the inherent variability in continuous processes.

Mechanistical insights of powder behavior in continuous processes

DFE Pharma recently performed study in which variation of excipients in continuous feeding and twin screw granulation is unraveled. Next to this the advantages of continuous mixing are emphasized.

Sharing intel on excipient variation

DFE Pharma has expertise of the functionality and variation of excipients in continuous processes. Next to uni-variate analysis, DFE Pharma is applying multi-variate analysis to gain better understanding of production variation. Combining the knowledge of a formulator or material scientist at pharmaceutical industry with the knowledge of DFE Pharma increases control. We are open to discuss your challenges, please use our contact page to get in touch.