Novozymes Biopharma says its new hyaluronic acid has sustainability, safety and production benefits for the pharmaceutical manufacturing sector.
The firm launched the excipient, named Hyasis, at CPhI in Frankfurt last week where Kim Johansen, sales director at Novozymes Biopharma, told in-Pharmatechnologist.com how it differs from hyaluronic acids (HA) already on the market.
“We produce Hyasis in an aqueous process using water and filtration whereas standard hyaluronic acid is produced using organic solvents,” he said, adding that “we also have a different bacterial strain we’ve modified to enable it to produce hyaluronic acid which is non-pathogenic.”
He went on to explain that this differs from traditional HAs that are either produced in strains of the Streptococci bacteria, which are pathogenic and can cause a variety of side-effects when used as drug ingredients, or extracted from rooster combs .
“Because it is derived from recombinant bacteria the purity profile of the material is much better [than competitor HAs]. We’ve reduce the levels of a lot of critical parameters in the material, such as iron, heavy metals, nucleic acids…so it can be used in a variety of more critical therapeutic areas.”
From a manufacturing standpoint there are also advantages according to Johansen, who highlighted the fact Hyasis is produced using spray drying, rather than precipitation, fluid bed or vacuum oven-based techniques as a particular strength.
“The production benefits we get out of this have an enormous impact for our clients,” he added, going on to say that Novozymes will roll out new grade or molecular weight versions of the product every few months with extra effort being taken for those intended for drug applications.
“Some of the grades that are for pharmaceutical use have higher demands for the dossier around the product so it takes a little while to launch those.”
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 developing the product for applications in ophthalmic drug delivery which Johansen said would be an important market going forward.
To meet this demand Novozymes has constructed a dedicated manufacturing plant in Tianjin, China, which became operational late last year.
The launch came just days before the news that biologics manufacturing products supplier Repligen was to acquire Novozymes Biopharma Sweden for €17m ($22.7m), however, this deal will have no impact on the Novozymes' Hyasis business.
A Novozymes spokeswoman told in-Pharmatechnologist.com that: "The acquisition here is only for a small part of Novozymes Biopharma. Hence the acquisition of Novozymes Biopharma’s unit in Sweden by Repligen has no bearing on Hyasis.
"Essentially Novozymes is divesting a smaller part of its Biopharma business that is not central to our core business which is focused around Albumin and HA based technologies.
Sixty-five people are employed at the Novozymes Biopharma’s facility in Lund, Sweden that Repligen is buying.
The spokeswoman said that "It is expected that a large portion of these employees will be joining Repligen, but as we are not aware of Repligen’s long term plans for the business, we cannot comment on any future impact on the organisation."