ABSTRACT
There are two stages where a biological product requires filling in containers for long-term storage. First, it comes at the end of the downstream cycle when a purified solution of a protein drug is ready to be filled into containers as a bulk drug that will be shipped out to companies to formulate and finish the product in a dosage form for the end customer. The second stage of filling is to formulate the bulk and fill into end-customer dosage form, a syringe, vial, or ampoule. The presterilized, single-use concept has already been realized with several off-the-shelf filling systems using peristaltic or gravimetric dosing. Many existing systems, however, are designed for low-speed, small-batch filling operations. Aseptic filling systems are available to fill bottles, bags, or drums from 5 milliliters up to 1,000 liters. There are tremendous advantages to the use of single-use, presterilized dosing systems for commercial filling operations.
