Berkshire Sterile Manufacturing (BSM), a MA-based fill finish CMO, has developed a new sterile filling process designed to reduce product loss for high-value drug product candidates. The process is intended for customers that have limited drug product and need to conserve every drop. It is additionally well suited for customers that have very small volume delivery needs with excellent precision. According to the company, filling is entirely isolator-based, easy to operate, and has demonstrated superior repeatability and accuracy.
 
Batches up to 1.1 L of drug product can be processed in a single run with very high precision and accuracy. During fill studies, individual fill volumes remained within 1% of the set dispense volume down to fill volumes as little as 75 micrograms.
 
“We were motivated to find a solution for a client that only had 150 to 300 mL of drug product available to fill. In their engineering runs, a significant amount of that product was lost in the tubing, filter holdup, and priming. This left the client with very little product from their starting batch,” said Process Engineering Manager, Dr. Jake Krans. “We met internally to develop a new fill process that would extend their product so that medicine could go to patients instead in line purges, line losses, weight checks, transfer losses, and other areas that reduce the amount of product available for the patient.”
 
“While the initial purpose of the process was to reduce product loss, we found that it had several other advantages, such as improved fill weight precision and compatibility with shear sensitive and viscous products,” said Vice President of Formulation and Tech Transfer, Dr. Xufeng Sun.