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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Even minor amounts of biological contaminants in your sample could cause unwanted biological effects,” Dr Amiji says. coli, where small amounts of contaminants could cause significant toxicity. In addition to this, there often needs to be additional scrutiny when assessing biosimilarity, especially as it concerns toxicity.

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Eurofins GeneScan Technologies Announces AOAC PTM Accreditation for the VIRSeek SARS-CoV-2 Detection Workflow on Environmental Surfaces under the AOAC SARS-CoV-2 Emergency Response Validation Program

The Pharma Data

The VIR Seek SARS-CoV-2 Solution is a comprehensive workflow for the detection of SARS-CoV-2 on environmental surfaces that includes swabbing of environmental surfaces, RNA extraction, analysis by Reverse Transcription PCR (RT-PCR) and evaluation by an advanced algorithm.

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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. Also, exosomes are mostly being used for the detection of circulating RNA and microRNA. “An Regulatory Approvals for Exosome-Based Liquid Biopsies.

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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. Biopharmaceutical filtration systems are designed to remove impurities and contaminants, to improve safety, purity and shelf life of the product. Particle Removal: This is the primary function of these filtration systems.

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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

Gene Delivery Systems Genetic material, in the form of DNA or RNA, does not easily enter cells without the aid of a delivery system. These individuals provide a perspective that is equally important for consideration when evaluating the risks to the study participants and clinicians, as well as to the community where the study is conducted.

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World’s Top 10 Pharma Companies (By 2023 Revenue)

XTalks

Issues of nitrosamine contamination during manufacturing have also plagued Januvia since 2022, compounding the decline in sales. RNA, radioligand and cell and gene therapy are three technology platforms that Novartis is focused on besides biologics and traditional small molecules. Bristol Myers Squibb Revenue in 2023: $45.00

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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.