Standardizing a TFF Operation
An industry leader in the development and production of biopharmaceuticals, with a USA-based commercial-scale GMP manufacturing facility, required the automation of a semi-manual tangential flow filtration (TFF) step to eliminate process risk.
The client’s Drug Master File could not be modified as a result and in addition, the process needed to be standardized to add the capability of greater cross-training.
The client preferred SOP driven processes with a single operator, or few skilled operators, trained to carry out the processes to ensure repeatability. However, this left operators constantly supervising GMP processes during campaigns and when the decision was made to scale-up the process, this was unsustainable.
Developing a Solution
An automated solution for a previously manual TFF process was required, which could be capable of executing the customer’s existing SOP while also simplifying and standardizing the process from the operators’ point of view. This way, a greater number of staff could be trained to carry out the process step.
In addition, logistically the solution had to have a small enough footprint to fit into the designated space.
The Parker domnick hunter SciPure TFF GMP-ready automated single-use tangenital flow filtration system was able to successfully deliver an automated solution. We implemented SciPres single-use pressure sensors inline for pressure monitoring and interlocks, as well as a 21 CFR Part 11 compliant data historian directly into their semi-manual process
As the room was very small, the SciPure design was able to eliminate two scales by integrating a WeighStation gravimetric fluid handling platform into the skid to mount the retentate bioprocess container, as well as adding automation to calculate and display the permeate weight without requiring a physical permeate scale.
The SciPure TFF solution was capable of executing the customer’s existing semi-manualSOP.
An additional benefit was that the SciPure TFF solution added the capability for cross-training and eliminated the learning curve associated with gaining experience in running the process.