Berkshire Sterile Manufacturing (BSM), a fill finish contract development and manufacturing organization (CDMO), completed their first GMP fill using their new low loss fill process. The process is an innovative sterile filling method that was designed to reduce drug product loss for low volume fills of less than 1.2 liters. An unintended benefit of the new process includes low shear.  

“This product was not manufacturable with the conventional fill finish process, so it was very exciting to be able to fill product that the client could use,” said BSM senior project manager, Alicia Rossie.

According to the company, the first sponsor to use the low loss fill process at BSM was motivated to reduce shear and avoid stainless steel for their liquid nanoparticle (LNP) drug product. The product was incompatible with the shear forces produced by peristaltic pumps and with the stainless steel in piston pumps.

Meanwhile, they opted to fill on BSM’s validated low loss fill process – a process that does not have a pump – to fill their drug product. BSM successfully manufactured vials with a 1mL fill volume for the sponsor to complete stability testing and clinical trials.

The low loss fill process uses a pressure vessel and a time/pressure filler to dispense the solution. Since the sponsor’s product was not compatible with steel, BSM utilized a vessel constructed of another material to pressurize the drug product, yielding 500 units with a 1 mL of product.

BSM expects to complete four other GMP fills using their low-loss fill process in the next few months. The process was validated in Dec. 2022 and demonstrated extreme accuracy and precision, low loss, and compatibility with shear-sensitive and viscous drug products. Filling occurs in an isolator for enhanced sterility assurance.