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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. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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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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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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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. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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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. During the webinar, Dr. Bahassi gave a brief schematic of how personalized, targeted assays can be developed to detect somatic mutations from cfDNA ( Figure 1 ).

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

Drug Discovery World

With only 10% of these conditions indicated for an approved therapy, there is a sizable opportunity for scientists and companies to develop treatments for patients with no other options to turn to. At this stage, qPCR can be used to check for IVT efficiency, residual DNA contamination and adventitious agents such as microbes.

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Improving quality control for CAR T cell therapies

Drug Discovery World

And as researchers study all of these factors, they are also discovering that CAR T cell development and manufacturing require a new approach to quality control to ensure their safety and efficacy. Developing the first CAR T cell therapy. These treatments have shown success in treating a variety ofcancers 4.