BioHale Sucrose is part of its new portfolio, BioHale, targeted at the biopharmaceutical manufacturing industry; the product, said to be low in endotoxin levels, looks to provide purity stabilization for biologics.
Excipients of high purity with low endotoxin levels are needed for the manufacture of injectable formulations, noted DFE Pharma. High endotoxin levels can undermine a finished product’s purity, biological activity, and shelf life, as well as potentially affecting patient safety.
“The stabilization process of biological drugs is challenging, as they are sensitive to temperature and light, susceptible to shearing and degradation, and not as durable and robust as small molecules,” Bas van Driel, CEO, DFE Pharma, told us.
Sucrose has a stabilization effect on biologics during the formulation process; it forms a glassy sugar coating around the biologic which inhibits molecular mobility, thereby stabilizing the drug.
COVID-19 linked shortages
Security of supply is of utmost importance and the demand for high quality excipients has grown, said the producer. The market has seen a shortage of certain excipients, including sucrose, due to the extraordinary hike in demand for such components arising from the production of COVID-19 vaccines, reported the Germany headquartered company.
Production of BioHale Sucrose has been underway for the past few months in DFE Pharma’s fully GMP and FDA audited facility in the north of the Netherlands.
“We anticipated the increased demand and have been investing in capacity; we are prepared to further scale up as needed,” said van Driel.
DFE Pharma, which is a long-standing producer and supplier of excipients for use in oral solid dose, inhalation, and nutraceutical formats, can commit to a global customer base due to its production locations in Europe, India and New Zealand, broad sales network, distributors and agents in more than 100 countries, stressed the CEO. “We can guarantee a robust supply chain, consistency of quality and high purity.”
Dual sourcing at its sites also backs up that promise of raw material supply security, he added.
The use of BioHale Sucrose is not limited to any therapeutic area, and BioHale excipients can be used for either the parenteral, ophthalmic, inhalation or oral route.
Going the biopharma route
DFE Pharma is already supplying lactose products used in injectables. “But three years ago we decided to expand our product range, and to create a division focused specifically on the biopharma space.
“As a market leader in pharmaceutical excipients, we are constantly looking at how to improve our services and products through innovation and the broadening out of our portfolio. The biopharma sector is appealing as it has been growing in recent years and is expected to further expand in the near future - almost 50% of new medicines in the pipeline are biologics, and the value of biologics is anticipated to overtake that of conventional medicines by 2024,” said van Driel.
The company is gearing up to launch an additional product in the BioHale line. BioHale Trehalose, said the CEO, will be introduced to the market in the coming months.