RESOMER® Sterile is the world’s first sterile PLGA polymer designed to allow a completely aseptic processing and avoid potential detrimental effects that may occur to solvent purified or vacuum distilled polymers, sensitive APIs or drug products during terminal sterilization. Utilizing a proprietary manufacturing process, this sterile PLGA polymer is supplied as a white powder tuned for optimized bulk density that makes it easy to handle during formulation. A wide range of RESOMER® catalog and RESOMER® Select products are suitable for use with RESOMER® Sterile as additional sterile PLGA polymer solutions.

RESOMER® Sterile is a sterile PLGA polymer designed for use with complex parenteral drug products that enables improved process controls and streamlines aseptic processing. It is suitable for use with a wide range of RESOMER® standard or RESOMER® Select custom polymers including solvent purified or vacuum distilled polymers. As this sterile PLGA polymer requires no further sterilization, it creates significant flexibility to streamline process steps for the aseptic manufacturing of parenteral drug products. To minimize degradation and protect overall polymer integrity, the proprietary sterilization process delivers an extremely low sterility assurance level (SAL) of 10-6. This process is not only robust but highly repeatable for optimum sterile PLGA polymer outcomes.

The improved process controls and streamlined steps for simplified aseptic processing with this sterile PLGA polymer can help to avoid potential detrimental effects on the polymer, sensitive APIs, or drug products that may otherwise occur during terminal sterilization. When used during electron beam (e-beam) sterilization, which is favored by many pharmaceutical companies due to its relatively mild conditions, potential affects including polymeric agglomeration, aggregation or fusion can be avoided and polymer degradation minimized. To enable easy handling during formulation and to further enhance processing performance, it is supplied as a free-flowing white powder or granular form that is tuned for optimized bulk density.

As a sterile PLGA polymer, RESOMER® Sterile provides the flexibility to formulate drug products utilizing a range of common powder or solution-based technologies during aseptic processing including hot melt extrusion. To simplify downstream drug product manufacturing, it is ideal for use when sterile filtration is not possible, such as for highly viscous solutions, with special solvents that are not compatible with the filtration membrane or to have the flexibility to decide for a more sustainable, cost effective and environmentally compatible option and reduce the amounts of solvents if a sterile filtration would require very high dilutions to be feasible.

RESOMER® Sterile builds upon more than 30 years of excellence for biocompatibility and safety that has been established under the RESOMER® portfolio of excipients for parenteral controlled release. Supply of sterile PLGA polymers can be conducted from either of our two GMP manufacturing sites in the U.S. and Germany. The platform is suitable for use with all catalog and custom RESOMER® polymers applicable for use with parenteral controlled release drug products.