Thursday, May 12, 2022 Daily Archives

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

The development of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional…

Poloxamer: A Simple and Powerful Solution for Accelerating Dissolution

While oral administration remains the most popular route for drug delivery, many of the active pharmaceutical ingredients (APIs) in use and development today exhibit low bioavailability, owing to low solubility which leads to a lower passage through the intestinal membrane, a key step to enter the systemic circulation. As such, formulators have developed a toolkit of enabling formulation techniques to increase bioavailability, including solid-state modification, formulation with lipids, salt formation with meglumine and complexation with cyclodextrins. However, the high degree…

Emergent ditched 400m vaccines amid quality and staff issues, report finds

Emergent BioSolutions hid evidence of contamination and destroyed nearly 400 million doses of J&J and AstraZeneca vaccines, a US Government staff report has found. Emergent was one of the benefactors from the US Government’s efforts in countering COVID-19, winning a Trump Administration contract worth $628 million to make the Johnson & Johnson (J&J) and AstraZeneca vaccines. However, the contract development and manufacturing organization (CDMO) was hit with an FDA Form 483 and a directive to stop production at its Bayview,…