Ferro develops high-purity parenteral sugars
maltose and trehalose sugars at the recent CPhI in Madrid, designed
to improve product quality and broaden the market for injectable
protein-based APIs.
These sugars aim to meet the emerging needs of customers seeking to stay ahead of the regulatory curve in the rapidly evolving biopharmaceutical market, which is being driven by the rising number of biologic drugs coming though the biopharma industry's pipelines.
The injectable drug market in particular is growing strongly at present, as most therapeutic protein drugs must be administered by injection.
When stabilising lyophilised proteins for injectable therapies, sugars are regularly used in order to ensure the proteins reconfigure correctly,
Sugars are technically categorised as excipients, and their regulations, which are outdated, are more tailored to oral, rather than parenteral therapies, allowing the use of food-grade sugars for injectable drugs, which actually require a much higher purity level of sugar.
As a result, adverse patient reactions have been associated with sugar polymers in injectable drugs. In addition, protein stability and efficacy can also be compromised by microbial contaminants and trace metal ions, which are not measured in food-grade sugars.
In response to this, the US, EU and Japan now apply the same rigorous manufacturing guidelines to sugar exipients as they do for APIs.
>Ferro's multicomprendial sugars are manufactured from the highest purity raw materials and are further processed under cGMP (IH-Q7A compliant) conditions suitable for the manufacture of regulated injectable formulation grade ingredients.
This assures that injectable formulations using these IH-Q7A-compliant sugars will adhere to API specifications and ease the regulatory approval of drug applications.
"Ferro is the only manufacturer of sucrose, maltose, galactose, manitol and trehalsoe which are IH-Q7A compliant, lot-to-lot consistant and have chemical and microbial purity," Dr John Minatelli, senior director commercial development told In-PharmaTechnologist.com.
Additionally, these sugars offer reduced transition metal ion and sugar polymer (glucan/oligomer) content (which can interfere with protein reconfiguration) and improved lyophilised protein drug stability.
"The cost of sugars is small compared to a kilo of protein-based therapeutic worth millions of dollars," said John Wailang, director, chemical and process technology, Ferro.
"Because biopharmaceuticals are very expensive, customers don't want to risk mixing a very expensive product with a low grade sugar," Minelli said.
US-based Ferro Pfanstiehl provides API chemical process development and contract manufacturing services for the pharmaceutical, biotechnology and other industries. The company specialises in isolation, purification, synthesis and development of high purity and low endotoxin injectable formulation ingredients, pharmaceutical intermediates and APIs.
