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vanmaarsum

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vanmaarsum

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Sunday, 06/03/2007 2:31:11 PM

Sunday, June 03, 2007 2:31:11 PM

Post# of 19309
Animal-free cell culture ingredients hit the shelves

By Anna Lewcock

31/05/2007 - Danish firm Novozymes has launched its first range of animal-free recombinant cell culture ingredients from its new business unit in the UK, offering biopharmaceutical firms an alternative to traditional serum-based production methods.

The Biopharmaceutical Ingredients business has launched the first three products in the range, focusing on the most vital growth factors for the biopharma industry.

The animal-free ingredients now available include the recombinant human insulin-like growth factor, LR3, the only such product on the market for use in cell culture. Manufactured to good manufacturing practice (GMP) standards, the ingredient has been shown to promote equivalent or greater productivity than recombinant insulin in a variety of cell lines.

Novozymes has also introduced DeltaFerrin, the first recombinant human (holo) transferrin, for commercial cell culture which supports cell growth in a manner equivalent to human transferrin, and performs more consistently across multiple cell lines than chemical chelators tested.

Finally, the company has also developed a number of animal-free recombinant versions of the widely used serum protein albumin for large-scale biomanufacturing.

The new products have all been developed through a combination of in-house research and the addition of expertise from recent acquisitions in the form of Delta Biotechnology (albumin experts) and GroPep, who contributed LR3.

Products and ingredients free of animal derivatives are becoming increasingly popular as regulatory authorities begin to crack down in a bid to improve safety profiles, banning some ingredients altogether and enforcing strict quality control measures on other animal-based products.

The contamination risk from pathogens such as viruses or prions when using animal-derived ingredients, and the damage the BSE crisis caused some manufacturers, is pushing some companies towards animal-free alternatives in a bid to eliminate the threat.

Although those who make the shift to reduced-serum or serum-free products have in the past had to suffer a reduced yield as a result, the Novozyme products claim to offer equivalent or increased yields compared to their animal-based counterparts.

Animal-free products can also lead to increased productivity via another route, a spokesperson for the company told in-PharmaTechnologist.com:

"With serum the quality between batches can be very variable," he said.

"This causes real headaches in quality control and can lead to a drop in productivity through additional QC measures. In contrast, this [product line] is batch-to-batch consistent."

Although firms opting for the animal-free ingredients will be paying for the added safety and productivity the products offer, the company was unable to disclose any specific pricing details. Novozymes has partnered with major distributors such as SAFC to make its products available to the biopharmaceutical industry.

With more products due to be added to the range over time, the strategic moves by Novozymes in this area look to be paying off already, taking advantage of the trend in the industry towards biopharmaceuticals and animal constituent free ingredients.

According to the company's financial results for the first quarter of this year, the biopharmaceutical ingredients business is blooming thanks the recent activities, with sales hitting around €16m compared to just €3m for the same period last year.

http://tinyurl.com/23wwef
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