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.