ADMA Biologics Inc (NASDAQ: ADMA) is heading to the top of the market this morning, and with good reason. The company said the FDA has approved its extensive manufacturing process. Here’s the scoop:
In the press release, Damage Biologics said the U.S. Food and Drug Administration has approved the company’s extensive manufacturing process, which will allow fractionation and purification of a 4,400-liter plasma pool to produce intravenous immunoglobulin.
The company further explained that the IVIG plasma pool scale of 4,400 liters for BIVIGAM will enable ADMA to expand the plant’s total capacity from 400,000 liters to an expected peak throughput of up to 600,000 liters.
Importantly, this approval allows the company to produce expanded capacity BIVIGAM with the same high quality as the previous production scale, all using the same equipment, release test assays, disposables and labor. In essence, the capacity increases with minimal cost increase.
As a result, the company said this will likely translate into meaningful gross margin improvements as manufacturing throughputs go through the standard 7 to 12-month manufacturing cycle for plasma-derived therapies.
In addition, the approval allows the company to offer BIVIGAM in two bottle sizes, 50 ml and 100 ml.