Brief: Adma Biologics Conformance Batch Production For Bivigam Is At Double Plasma Volume Of Current FDA Approved Process

ADMA Biologics

07/05/2020 13:22

May 7 (Reuters) - ADMA Biologics Inc  ADMA.O :
    * ADMA BIOLOGICS INC -  CONFORMANCE BATCH PRODUCTION FOR
BIVIGAM
IS AT DOUBLE PLASMA VOLUME OF CURRENT FDA APPROVED PROCESS
    * ADMA BIOLOGICS INC - THERE HAVE BEEN NO SIGNIFICANT
CHANGES TO
MANUFACTURING PROCESS, IN-PROCESS CONTROLS OR FINAL RELEASE
TESTING
    * ADMA BIOLOGICS INC - AT INCREASED SCALE, OBSERVED SAME
POTENCY
AND PURITY OF IG PRODUCTION PROCESS AS FDA-APPROVED PROCESS
    * ADMA BIOLOGICS INC - UPON APPROVAL, ANTICIPATES IT WILL BE
IN
POSITION TO PRODUCE DOUBLE PEAK FORECASTED QUANTITY OF BIVIGAM
    * ADMA BIOLOGICS INC - ANTICIPATES SUBMITTING APPLICATIONS
TO FDA
FOR INCREASED PRODUCTION SCALE CONFORMANCE BATCHES OF BIVIGAM
DURING 2H

Source text for Eikon:  ID:nGNX41JrsT 
Further company coverage:  ADMA.O 

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