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Quality by design with a focus on biosimilars

Pharmaceutical Technology

For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve. Even minor amounts of biological contaminants in your sample could cause unwanted biological effects,” Dr Amiji says.

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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. Exosomes are extracellular vesicles that contain molecular cargoes (such as various proteins, RNAs and DNAs) specific to the origin cell.

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Improving quality control for CAR T cell therapies

Drug Discovery World

To prevent these potentially fatal side effects, the US FDA recommends that manufacturers who generate CAR T cells using retroviral or lentiviral vectors screen out batches that contain more than four transgene copies per cell 13. Meanwhile, droplets that do not contain the template strand only emit weak fluorescence.

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COVID-19 Pandemic Coverage

XTalks

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months. Drugs and Vaccines.