News of the product, which will be officially launched later this year, comes ahead of Novozyme’s presentation at the joint SOE and AAO conference in Switzerland next month.
Khadija Schwach-Abdellaoui, Novozymes' director of biopharmaceutical application development told in-Pharmatechnologist.com the firm will report data from an in vivo study which showed the HA was not associated with lesions on the cornea and “can be used as a safe ingredient in topical ophthalmic formulations.”
She also stressed the advantages of Bacillus-derived HA for manufacturers, claiming that its porosity and reduced particle size means the product dissolves up to 35 per cent faster than Streptococcus derived HA’s.
“Pharmaceutical companies are under ever-increasing pressure to take new products to market faster, working with raw materials that are already Q7 cGMP compliant will accelerate regulatory processes and significantly reduce testing time, making HA economically efficient.”
HA for delivery
Novozymes has been building its Bacillus-derived HA business since 2002 when it acquired the technology required to manufacture the recombinant product for use in topical medicines.
Since 2005 the firm has been on developing the product for applications in ophthalmic drug delivery which, according to Schwach-Abdellaou, is set to be an important market going forward.
“Over the next few years, there will be more products that combine HA with therapeutics for the treatment of OA, ophthalmic diseases, adhesion prevention and other applications.”
To meet this demand Novozymes has constructed a dedicated manufactruing plant in Tianjin, China. The facility, work on which began in 2009 , is due to become operational later this year.
“Our goal has always been to develop a more consistent source of sodium hyaluronate, with a high degree of purity and the new facility deliver largescale Q7 cGMP grade HA that will enable all regulatory requirements for using HA in drug products to be met.”