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Six Factors for Biotech Companies to Consider When Choosing Next-Generation Contract GMP/CMC Laboratories

PPD

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Reflecting on ELRIG’s Drug Discovery 2022 

Drug Discovery World

Meanwhile, Stratech Bio were on hand to answer enquiries about their range of raw materials, kits and assays for R&D or bioprocessing projects. Not to mention, the 2023 calendar which, if the year-on-year trajectory continues in the same way as Drug Discovery 2022, should be a landmark year for drug discovery. .

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Early phase support for plasmid DNA supply to secure future manufacturing

Drug Discovery World

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). Figure 1: The integrated development pathway for cell and gene therapies.

DNA 130
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Advances in cell line development

Drug Discovery World

Reece Armstrong offers an overview of cell line development and outlines the benefits the technology is bringing to biopharmaceutical developers. Cell line development is an essential underpinning of the drug development process, enabling teams to test, optimise and manufacture therapeutics at a commercial scale.

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The path to improved safety of gene-based products

Drug Discovery World

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Novel gene-based drugs can be severely impacted when HCPs are not distinguished and quantified individually. coli, and Pichia cells. 2022): 947.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. Even under the shadow of the Covid-19 pandemic, 1.2