Aseptic Fill & Finish
Before being sent into the cGMP filling suite, your product is formulated and sterile filtered to ensure a stable and quality final drug product. If you have an existing formulation, we can transfer and adapt your process to our facility. If your product is in need of a clinical or commercial formulation, our formulation scientists will work with you to design a formulation that addresses any challenges with stability, efficacy, potency, or safety that are associated with your molecule. In executing the product formulation, we have special expertise in complex liquid formulations such as liposomes & nanoparticles, conjugates, crystallized proteins, adjuvants, and viscous products. In formulating product, simple or complex, we leverage the use of microfluidizers and static mixers, and can perform filtrations on the scale of syringe filters up to cartridge filtration.
Once we have your formulated product ready for filling into vials or syringes, the liquid product is transferred directly to the appropriate cGMP fill suite to be aseptically filled into the final dosage form. Whether you are entering the clinic to achieve proof of concept or pushing on into commercialization, we have the capability and capacity to support you with formulated product in vials or syringes.
PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.
QUALITY & REGULATORY
Taking pride in our history of quality.
Aseptic formulation and fill of a micronized drug suspension. We have produced many suspension products that incorporate the use of a sterilized inline homogenizer (for drug wetting) and a sterilized Microfluidizer (for particle size reduction to micron-sized particles). Product was filled with constant mixing to maintain the suspension. Aseptic process simulation with growth promoting media was used to validate the process.