Tag: <span>subunit vaccines</span>

From the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs”

When I go to a therapeutic protein meeting, it’s very hard for me to hear these products referred to as “drugs.” But since they are being regulated by CDER, it’s a little easier to swallow. However, calling viral gene vectors and cellular therapies “drugs” is a bridge too far. My advice to my good friends at CBER is to keep calling their products “biologics,” or they may lose all of their regulatory responsibilities to CDER…

Read MoreFrom the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs”

Biologics Production

biologics bioproduction cber cder cellular therapies drug product FDA monoclonal antibodies odat regenerative tissues subunit vaccines viral gene vector

From the Editor-in-Chief: Many of the Toughest Biologicals are Becoming Easier to Produce

There are so many exciting things happening in the biotech industry. As we have all seen, antibody products are being approved for more and more cancer applications, in addition to those for auto-immune diseases, which used to dominate how they were being used. And of course, these applications are in addition to the many which use antibodies conjugated to chemotherapeutic drugs and imaging agents—where the antibody acts as a targeting mechanism. Then there are the hundreds of monoclonal and polyclonal antibody applications that have dominated diagnostic testing for decades…

Read MoreFrom the Editor-in-Chief: Many of the Toughest Biologicals are Becoming Easier to Produce

Biologics Production

aav adeno-associated virus air handling antibody conjugates biologics bioproduction cryopreservation diagnostic testing ind investigational new drug lentiviral vector systems monoclonal antibodies polyclonal antibodies regenerative tissues subunit vaccines transient transfection viral gene vectors