Ques- At Preclinical stage (for a biosimilar company), how many Drug Substance and Drug Product batches should be set /charged. Currently, we follow ICH Q5C strictly. Is that OK?
I have generated some information for you (please see below):
1. Health Canada (Information and Submission Requirements for Subsequent Entry B iologics (SEBs) “The measurement of quality attributes in characterisation studies does not necessarily entail the use of validated assays, but the assays should be scientifically sound and provide results that are reliable. Those methods used to measure quality attributes for batch release should be validated in accordance with ICH guidelines (ICH Q2A, Q2B, Q5C, Q6B), as appropriate.”
2. Semler Research - Formulation Development institute for preclinical studies:
“Stability study: Solution stability, pH depended solubility, process equipment compatibility study, filter compatibility study, solid state stability, stress stability, photo stability, accelerated stability study as per ICH guidelines “ Ref -http://www.hotfrog.com/Companies/Semler-Research-Centre/Semler-Research-Formulation-Development-221182
3. FDA Generic Drugs: Information for Industryhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm
4. Division of Manufacturing and Product Quality (HFD-320):http://www.fda.gov/aboutfda/centersoffices/cder/ucm096102.htm
There are several specialists in product manufacturingincluding Pre-Approval Inspections (NDA/ANDA), Process Validation, Product Stability and others that you can contact directly.
Hope that this will help
Thank you for your time and concern...