May 7, 2020 / 12:25 PM / a month ago

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

May 7 (Reuters) - ADMA Biologics Inc:

* 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: Further company coverage:

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