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. And, like it has before , the District Court of D.C. recently grappled with this very question in Ipsen v.

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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.

Fragment Screening 96

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. Recombinant protein therapeutics from CHO cells — 20 years and counting. 2007), 103(7): 40–47.

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Engineering DNA Laboratories Production 105

Dark Matter Blog

JULY 16, 2021

At Biogen, my group’s work covered a range of technology development areas including protein production in mammalian cells, intracellular protein delivery (our work on HIV Tat started the field of cell-penetrating peptides) and novel gene delivery vehicles, as well as biological drug discovery and development.

Small Molecule 52

Small Molecule RNA Clinical Trials DNA 52

Codon

AUGUST 10, 2023

BMC Systems Biology (2007). Link The PURE system for the cell-free synthesis of membrane proteins , by Kuruma Y. & Link An integrated cell-free metabolic platform for protein production and synthetic biology , by Jewett M.C. Link Cell-free biosensors for rapid detection of water contaminants , by Jung J.K,

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DNA Cell Biology Molecular Biology Engineering 98

Codon

AUGUST 10, 2023

BMC Systems Biology (2007). Link The PURE system for the cell-free synthesis of membrane proteins , by Kuruma Y. & Link An integrated cell-free metabolic platform for protein production and synthetic biology , by Jewett M.C. Link Cell-free biosensors for rapid detection of water contaminants , by Jung J.K,

DNA 52

DNA Cell Biology Engineering Molecular Biology 52