Manufacturing

PROMAXX microsphere manufacturing brings the benefits of a water-based process with tight microsphere size control and high drug loading to product development.

Simple robust process

The PROMAXX manufacturing process consists of a simple, robust, gentle process that is water-based whenever possible. This has been shown to preserve the drug’s protein structure and activity.

Scalable and transferable

PROMAXX's manufacturing process has been shown to be scalable from laboratory-scale batches to full commercial-scale production. Moreover, Baxter has experience with technology transfer, and providing you the option to integrate our formulation technology into your manufacturing operations.

Tight size control increases yield

The PROMAXX system results in high yield by producing homogeneous microspheres that are spherical and uniformly sized. Direct control of microsphere size eliminates the need for complex, expensive size-sieving processes, thus decreasing costs and increasing yield.

High drug loading

In the PROMAXX system the drug candidate, with or without carrier protein, forms the microsphere matrix. This allows for very high drug loading which may significantly reduce the volume of product required for drug administration.

Comparison of Drug Delivery Technologies
	PROMAXX Technology	Other Polymers	Lipid
Versatile
Multiple types of drugs	+	+	+/–
Multiple routes of administration	+	+	+
Simple Manufacturing
No size sieving	+	–	–
High loading	+	–	–
Scalable	+	–	–
Adaptable to contract manufacture	+	–	–

PROMAXX sustained release products

The first application for the PROMAXX technology was the development of two sustained release formulations. One-Month and Three-Month injectable sustained release formulations were developed using the PROMAXX microsphere technology. These formulations demonstrated an appropriate pharmacological effect, when tested using a standard rat model.