Cell and Gene Therapy, Industrial Impact

The EU Clinical Trials Regulation − What You Need to Know

March 22, 2022

The EU Clinical
The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic. 

Spotlight

Feldan Therapeutics

Since its beginning, Feldan has valued internal research with the aim of innovating, changing standards of care and redefining quality of life. With the recent development of the Feldan Shuttle, this approach is starting to show its promises. Feldan’s mission is to develop regenerative medicine therapeutic applications based on Feldan’s proprietary technology. The scientists at Feldan have developed the Feldan Shuttle, a protein-based technology platform that directly delivers proteins – such as nucleases or transcription factors - inside cells to specific cellular compartments.

OTHER WHITEPAPERS
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Long-term follow-up studies of cell and gene therapies

whitePaper | September 29, 2022

The market is experiencing a surge in the availability of cell and gene therapies (CGTs); it’s estimated that by 2025 as many as 20 will be introduced into the US each year.1,2

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Lentivirus production study in the scale-X™ fixed-bed bioreactor

whitePaper | April 24, 2023

Implementation of a metabolite-based cell density<br /> estimation and evaluation of harvest strategies for<br /> Lentivirus production with HEK293T cells

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Innovative strategies to maintain product integrity in Biologic andBiosimilar clinical studies

whitePaper | August 7, 2022

The number of biologic new molecular entities approved by the FDA has increased over the last five years indicates a growing focus on biosimilar.

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GMP Grade PMSF and Protease Inhibitors

whitePaper | February 23, 2023

Phenylmethylsulfonyl fluoride, better known as PMSF, is a small molecule serine protease inhibitor used to prevent unwanted proteolysis.

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Considerations for migrating a drug product presentation from vial to pre-filled syringe

whitePaper | December 9, 2022

There is an upward trend for pharmaceutical companies to ask their contract development and manufacturing organisations (CDMO).

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70 years of wood modifcation with fungi

whitePaper | March 18, 2022

Fungi are usually seen by the wood used only as destroyers or parasites. Material infestation should be avoided as far as possible for wood preservation reasons.

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Spotlight

Feldan Therapeutics

Since its beginning, Feldan has valued internal research with the aim of innovating, changing standards of care and redefining quality of life. With the recent development of the Feldan Shuttle, this approach is starting to show its promises. Feldan’s mission is to develop regenerative medicine therapeutic applications based on Feldan’s proprietary technology. The scientists at Feldan have developed the Feldan Shuttle, a protein-based technology platform that directly delivers proteins – such as nucleases or transcription factors - inside cells to specific cellular compartments.

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