SAFC Biosciences has unveiled an analogue of insulin specifically designed for the large-scale manufacturing of recombitant biopharmaceuticals, promising security of supply and product consistency.
Although recombinant insulin is primarily supplied as a therapeutic to the diabetes market, it is also used as a growth factor supplement for the industrial production of biopharmaceuticals.
However, the long term supply of recombinant insulin to the biopharmaceutical manufacturing market is uncertain, since its demand by diabetics makes it prone to market fluctuations and shortages.
In addition, the manufacture of recombinant insulin has been modified to include an animal derived component, despite the sustained pressure from regulatory authorities to eliminate animal derived products from biopharmaceutical processes.
So SAFC is targeting the industrial cell culture market with LONG R3IGF-I (LONGTMR3), a recombinant growth factor analogue of human insulin-like growth factor I (IGF-I), which is produced by E.coli in a completely animal-component free (AFC) system.
This growth factor binds to IGF-I receptors to stimulate cell growth in serum-free media, but, unlike insulin, it is made exclusively for use in cell culture.
It promotes cell proliferation, increases cell survival, inhibits intracellular apoptotic pathways, extends culture longevity, eases transition to serum-free media and increases recombinant protein production.
Furthermore, SAFC says LONG R3 is currently used in several biopharmaceutical products approved by US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) and is being evaluated by more than 100 companies.
"The launch of the growth factor LONG R3 marks a major breakthrough in the commercial production of a number of key recombinant biopharmaceutical proteins," Rod Kelley, president of SAFC Biosciences, commented.
"We are pleased to offer a supplement for serum-free media, designed specifically for industrial cell culture use, which will ease concerns of supply chain managers worldwide as well as alleviate regulatory pressures due to its animal component-free status."
In 2000, SAFC, a member of the Sigma-Aldrich Group, obtained exclusive marketing and distribution rights for LONG R3 from Australian biopharmaceutical firm GroPep.
GroPep says it has manufacturing capacity to supplement more than 80m liters of serum-free media and can rapidly scale up manufacturing if required.
Moreover, a duplicate cell bank is also stored off-site, while a second manufacturer is currently being qualified.
"The uncertainty in the market has provided GroPep and SAFC Biosciences with an opportunity to inform the industry that LONG R3 can be reliably sourced for the long term and is devoid of any animal components," Bob Finder, CEO and managing director of GroPep, said.
"These features are crucial to the industrial manufacture of biopharmaceuticals and we believe that the launch of this campaign could not be more timely, since users of recombinant insulin will now have a superior alternative."
LONG R3 is available as a freeze-dried powder in 1, 5, 10, 20 or 50mg size vials and a liquid formulation of the growth factor is also available as a custom product for large-scale manufacturing applications.