Novozymes Biopharma signs agreement to supply GMP albucult® (recombinant albumin) for use in medical devices

The agreement will result in the launch of the first Class III medical device (used in high-risk applications such as pacemakers and heart valves) containing albucult.

Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, has signed a supply agreement for albucult, recombinant albumin, with one of the world’s leading manufacturers of medical disposables for open-heart surgery.

This supply agreement further strengthens the relationship and consolidates the already successful partnership between Novozymes and this leading manufacturer of medical disposables for open-heart surgery. The agreement will result in albucult being used in a Class III medical device product for the first time. Class III devices are highly regulated high-risk medical devices, for example pacemakers and heart valves.

“Novozymes Biopharma is pleased to consolidate its position in the medical device market with the signing of this long-term agreement. This continued partnership demonstrates our strength and extensive understanding of manufacturing, regulatory affairs, and global supply, making Novozymes an ideal partner to work with,” says Dermot Pearson, Marketing Director, Novozymes Biopharma.

Improved biocompatibility in life-support devices
Class III devices are life-support or life-sustaining devices, and their stability and biocompatibility (the ability of a medical device implanted in the body to be compatible without eliciting any undesirable effects) are critical for the success of the medical treatment/intervention. The use of albucult within such medical devices (pacemakers, heart valves, etc.) offers improved biocompatibility – therefore improving the chances of the device being accepted by the body.

Use of albucult in Class III medical devices also offers a range of other unique advantages, including sustainability of supply at GMP-compliant levels and batch-to-batch consistency, which can significantly reduce lot-testing burdens for clients. 

Derived from Novozymes Biopharma’s proprietary yeast expression technology, albucult delivers unprecedented performance and quality benefits to medical applications including device coating, sealants, and cell therapy applications. A recombinant human albumin developed and supplied for use as a bulk drug or device-manufacturing ingredient, albucult can also be used in advanced cell therapy products.