We have encountered a result of some unqualified liquid Mab formulation during a batch manufacturing run. There are several (1-3) white-colored visible micro-particles suspended in the middle of the final liquid formulation in the vial. We have conducted DOE studies to define the process parameters; basically the parameters for the Fill and Finish like temperature, filling speed, however the results hasn't provided any clues. Currently, we are working with a research group in Italy to try to do some particle ID studies.
Please give some insights to help us to start with. How can we call this kind of appearance defect? Is there any reference or paper to check?
Thank you for your time to read. Please leave your thoughts down below.
Before all that tests, check the overall cleanliness, any defective polymeric source(s) in the experimentation-storage-processing etc., greasy material presence and, probably degraded or impure raw material- the starting point. The next would be to go to the ionic sources including cationic or anionic (of whatever molecular sizes) in the process steps being generated or already present. If the final product qualifications are literally matching, problem is in media and surrounding material which is producing the white entities. Sudden pH changes are also responsible for these kinds of impurities provided ionic components are being carried in the production.
Thank you.
- Badges
- Science topic
- Similar topics
- Biological Science
- Biochemistry
- Biochemical Techniques
- Analytical Chemistry
- pH