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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Even minor amounts of biological contaminants in your sample could cause unwanted biological effects,” Dr Amiji says.

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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. The team used two safeguard methods to prevent the bacteria and their modified genes from escaping into the wild.

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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. FoundationOne ® Liquid CDx (Foundation Medicine; end-to-end commercial provider). Bahassi during the webinar and is shown in Table 1.

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

Drug Discovery World

In addition, the purity of the final product can be evaluated by using ultrasensitive digital PCR, to detect any residual non-mRNA products, and 16S sequencing, to identify bacterial contamination. The structure of the mRNA is of key importance as it influences the translation efficiency and stability of the transcript in the cell.

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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.

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Improving quality control for CAR T cell therapies

Drug Discovery World

Although this type of contamination has not yet been reported in humans, RCVs can form rapidly growing T cell neoplasms, another type of cancer. Unlike qPCR, which requires users to generate a standard curve to estimate the concentration of DNA or RNA in a sample, ddPCR technology quantifies nucleic acids directly. Clinicaltrials.gov.[link].

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Can your LNP manufacturing platform cope with the pace of the mRNA revolution?

Pharmaceutical Technology

Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022. GlobalData pharmaceutical analysts project that RNA-based gene therapies for oncology will grow from zero in 2022 to $4.6 billion by 2028. billion by 2028.