Pfizer Inc.: Trazimera

To support a well-controlled and consistent commercial production of PF-05280014, you will need to provide adequate data and information to confirm the stability of the MCB.

Provide the shipping validation summary report of the passive pallet shipper in the actual shipping lanes during winter and summer conditions in the BLA resubmission.

Agency's information request dated December 26, 2017. We disagree with your assessment that the © is a low risk operation.

10. The maximum hold time of PF-05280014 drug produc © proposed in the BLA is not supported by relevant microbiology data.

Provide summary microbial data from hold time studies conducted in the holding vessels used for PF-05280014 in the BLA resubmission.

For each capper, specify a maximum differential force and provide summary results which demonstrate container closure integrity after capping at a maximum differential force in the BLA resubmission.

Provide the LER study report in the BLA resubmission which describes the method performed and includes raw data (+/- gel clot) to support the reported percent recoveries.