FDA Law Blog: Biosimilars

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.”

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FDA Regulations Production Small Molecule 95

Drug Target Review

NOVEMBER 1, 2023

We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant protein production. With all these diverse methods we characterise protein-ligand interactions in many ways.

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Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

Drug Target Review

JULY 5, 2023

5 And for the latter, the development of a technique to temporally track gene expression in CHO cells, which therefore has the potential to lead to the identification of targets to improve recombinant protein production. Biotechnol Progress (2010), 26: 1455-1464. Porter AJ, Racher AJ, et al. Zingaro K, Shaw D, et al.

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Engineering DNA Laboratories Production 105

Codon

MARCH 24, 2024

This was the founding ethos of Moderna, the mRNA vaccine developer, when it was launched in 2010 by Noubar Afeyan and Doug Cole at Flagship Pioneering. In 2012, an Israeli company called Protalix gained approval for their plant-based enzyme product for Gaucher’s disease. “It was about 6 p.m.

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Engineering Vaccine Production RNA 84

PLOS: DNA Science

JUNE 13, 2024

The most compelling evidence for the origin lies in the RNA genome sequence similarities between RaTG13 and SARS-CoV-2 – specifically, a part that encodes the “furin binding site” of the spike protein with which the virus adheres to host cells. The viruses differ at one end of the gene that encodes the spike protein.

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Virus RNA DNA Science 52

Codon

MAY 30, 2023

Read Maximizing protein production by keeping cells at optimal secretory stress levels using real-time control approaches. Read Modular metabolic engineering and synthetic coculture strategies for the production of aromatic compounds in yeast. Materials Today Bio. Read Living microecological hydrogels for wound healing.

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DNA RNA Engineering Vaccine 52

Codon

MAY 30, 2023

Read Maximizing protein production by keeping cells at optimal secretory stress levels using real-time control approaches. Read Modular metabolic engineering and synthetic coculture strategies for the production of aromatic compounds in yeast. Materials Today Bio. Read Living microecological hydrogels for wound healing.

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DNA RNA Engineering Vaccine 52