FDA Law Blog: Biosimilars

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. By Sophia R.

Protein Production 59

Protein Production Production DNA Regulations 59

Dark Matter Blog

JULY 16, 2021

As soon as I learned about DNA and RNA, I wanted to be a molecular biologist. Last stops at RNA My last roles in biotech were where my original passion began: DNA and RNA. I did a postdoc with Paul Berg at Stanford, studying transcriptional regulation. The only subject in school that held my interest was biology.

Small Molecule 52

Small Molecule RNA Clinical Trials DNA 52

Codon

MARCH 24, 2024

Credit: Universität Würzburg Archives His key insight hinged upon the fact that living cells are essentially bags of liquid filled with enzymes, or proteins that speed up chemical reactions. Water accounts for 70 percent of a bacterium by mass; the other 30 percent includes everything else: proteins, RNA, DNA, lipids, and so on.

Engineering 86

Engineering Vaccine Production RNA 86

Codon

MARCH 20, 2023

Self-regulating living material with temperature-dependent light absorption. Digital nanoreactors to control absolute stoichiometry and spatiotemporal behavior of DNA receptors within lipid bilayers. Peroxisomal metabolic coupling improves fatty alcohol production from sole methanol in yeast. Nature Communications. Blackmore DG.

Virus 52

Virus Engineering RNA Small Molecule 52

Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” morphological cell changes or alterations in protein production or expression).

Production 40

Production FDA Therapies Biochemical Assays 40

PLOS: DNA Science

AUGUST 8, 2024

The brain’s hypothalamus malfunctions and can’t regulate appetite, and so children can’t sense when they are full. This part of chromosome 15 is especially unstable because highly repetitive DNA sequences bracket the genes associated with the symptoms. Repeats can cause slippage as DNA replicates.

Small Molecule 52

Small Molecule DNA Drugs Protein Production 52

Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S. & Xie X.S.

DNA 95

DNA Cell Biology Molecular Biology Engineering 95