User Community

"This would be of great help for sure, better knowing and modelling the relationship between structure and function and above all the predictive impac...

"Yes, understanding the structure–function relationship of heterogeneous biomolecules is essential for setting patient-centric specifications. It help...

"The dossier holder (client) is responsible for the specifications, even if the product is manufactured by a CRO. The CRO may propose or assist in dev...

"Planification is or should always be possible even for biological products this means that planning for doing DoEs to define NOR and PAR is available...

"I think in general, one could always overthink ECs. Nonetheless, in earlier phases with little prior knowledge, effort is needed to set up ECs. It is...

"The implementation of the Analytical Target Profile (ATP) within the company involved several important aspects. Initially, the ATP served as a tool ...

"Robustness testing is a frequently debated topic, particularly regarding how and when it should be performed. Guidelines are often interpreted to mea...

"The statistical approach underlying an assay failure risk assessment can take many forms. Populating the various fields of an FMEA can be supported b...

"In my opinion, using trending data to complement—or even shorten—validation studies should not be an issue, provided it's done appropriately. The pri...