Minimizing volume losses in small-scale aseptic fill finish for high-value drug products

Minimizing volume losses in small-scale aseptic fill finish for high-value drug products

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About this white paper:

Aseptic filling is common since many drug products are denatured during terminal sterilization. However, sterile filling can involve significant drug product loss. This is concerning for high value drug products, where the active pharmaceutical ingredient (API) is either exceptionally expensive, complex to produce, or have long production lead times. It is possible that a drug product can exceed $1Million for a single liter. This is the same volume that many CMOs providing aseptic filling expect to lose during the fill finish process. 

This white paper discusses how hold up volumes or losses can be minimized by determining the elements that contribute to them and working to minimize or eliminate each. This paper presents several solutions to reduce volume losses during filtration, filling, and inspection. If these solutions are implemented correctly, volume losses can be minimized to 50 – 75mL for 1L of drug product. The portion of drug product lost will be even less for larger drug product volumes.

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Reducing loss in fill finish for high-value drug products