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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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Blood Donor Day 2023: Experts weigh in 

Drug Discovery World

In acknowledgement of Blood Donor Day 2023, DDW spoke with industry experts about the significance of blood donorship in drug discovery. BCA members and affiliates ramped up to collect over 670K doses which were used to treat patients before other therapies were available.

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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.

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Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies). In fact, the FDA estimates that the accelerated approval program is responsible for access to life-saving anti-cancer therapies a median of 3.4 years before they would have been available otherwise.

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Advances in cell line development

Drug Discovery World

The market for cell line development is currently rising due to an increased focus by the life sciences sector on biopharmaceuticals and targeted therapies. According to Grand View Research, the global cell line development market was valued at $4.81 There are a lot of considerations to take when choosing a cell line.

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