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Hello there, i have the following question regardless of the functional assay prior to the Clinical trial. Do we need to use validated methods for the SPR (FCgamma receptor and IgE binding) for the characterization purpose? ------------------------------ Alejandra Cruz Innovation Manager México Mexico ...

Hello everybody. We have a single use Biotec facility with just one process of manufacturing at the moment (mAb). However, we are about to share this facilty with a process of manufacturing another protein using cell insect expression plattform, and we are plannig the modifications to the facility ...

Hi all,  Thanks for your comments, I understand better we don't intend to use the drug product with the new cell culture media in the clinical study, we are exploring two possibilities:  to execute the clinical study with material manufactured with the current process and implement the change ...

Hi all,  What is the documentation to be supplied, if we want to implement a change of culture media to increase the productivity of the upstream process, after of manufacturing clinical material but before of submit marketing authorization? I appreciate your comments, ----------- ...

Hello: What is your opinion regarding the DRAFT GUIDANCE, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin? Do we need to performance a extensive clinical study or a bioequivalence PK is enough? Thanks in advance! Alejandra Cruz Project ...