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Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Scientists engineer safe, virus-resistant E coli for research

Drug Discovery World

The work promises to reduce the threats of viral contamination when harnessing bacteria to produce medicines such as insulin as well as other useful substances, such as biofuels. Currently, viruses that infect vats of bacteria can halt production, compromise drug safety, and cost millions of dollars. “We

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Also, exosomes are mostly being used for the detection of circulating RNA and microRNA. “An

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FDA approves twice-yearly resistant HIV therapy from Gilead

pharmaphorum

In trials, 81% of participants taking the regimen achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable after six months, with 83% showing continued suppression in viral load after a year. Lenacapavir is the first and so far only capsid inhibitor to reach the US market.

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Unlocking the potential of mRNA for the future treatment of rare diseases 

Drug Discovery World

At this stage, qPCR can be used to check for IVT efficiency, residual DNA contamination and adventitious agents such as microbes. The post Unlocking the potential of mRNA for the future treatment of rare diseases appeared first on Drug Discovery World (DDW). The identity of the transcript is confirmed by Sanger sequencing.

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Improving quality control for CAR T cell therapies

Drug Discovery World

For example, one clinical trial examined the safety and efficacy of a CAR T cell that includes a suicide gene, which produces a toxic protein that causes the CAR T cells to die upon exposure to a drug 10. In general, cell therapies represent a new kind of ‘drug’—one that is living, and therefore cannot be fully predicted or controlled.

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Biopharmaceutical Filtration: A Deep Dive

Roots Analysis

It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Techniques Involved in Biopharmaceutical Filtration Process Biopharmaceutical drugs often require specialized filtration techniques to remove impurities and ensure the final product meets purity and safety requirements.