Archive for November, 2025

Rho GTPase Signaling in Structural Plasticity and Dendritic Spine Remodeling

Posted by Michael A. S. Guth on November 23rd, 2025

Rho GTPase Signaling in Structural Plasticity and Dendritic Spine Remodeling Structural plasticity, the physical reshaping of dendritic spines, is the anatomical correlate of long-term information storage. The dynamics of the actin cytoskeleton are the primary driver of these morphological changes, and the Rho family of small GTPasesโ€”RhoA, Rac1, and Cdc42โ€”serves as the master regulator of […]

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The BCM Theory and the Molecular Implementation of Metaplasticity

Posted by Michael A. S. Guth on November 23rd, 2025

The BCM Theory and the Molecular Implementation of Metaplasticity The Bienenstock-Cooper-Munro theory provides a theoretical framework for understanding how a synapse’s history of activity governs its future plasticity, a concept known as metaplasticity. It posits a sliding threshold, ฮธM, which determines whether synaptic activity will induce long-term potentiation or long-term depression. This dynamic threshold is […]

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The Molecular Symphony of Hebbian Plasticity: Beyond “Neurons That Fire Together

Posted by Michael A. S. Guth on November 23rd, 2025

The NMDA Receptor as a Coincidence Detector: A Deep Dive into Hebbian Plasticity The foundational model for activity-dependent synaptic plasticity is Hebb’s postulate, which finds its primary molecular mechanism in the N-methyl-D-aspartate (NMDA) receptor. This ligand-gated ion channel is unique in its requirement for dual activation: binding of the neurotransmitter glutamate and the simultaneous relief […]

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Pro-Oxidant High-Dose Vitamin C Infusions for Cancer

Posted by Michael A. S. Guth on November 22nd, 2025

๐“๐ก๐ž ๐š๐ซ๐ญ๐ข๐œ๐ฅ๐ž ๐›๐ž๐ฅ๐จ๐ฐ ๐ฆ๐ž๐ง๐ญ๐ข๐จ๐ง๐ฌ ๐š ๐ฌ๐ญ๐ฎ๐๐ฒ ๐ญ๐ก๐š๐ญ ๐ข๐ฌ “๐ฉ๐จ๐ฌ๐ข๐ญ๐ข๐ฏ๐ž” ๐ข๐ง ๐ญ๐ก๐ž ๐ฌ๐ž๐ง๐ฌ๐ž ๐ญ๐ฒ๐ฉ๐ข๐œ๐š๐ฅ๐ฅ๐ฒ ๐Ÿ๐จ๐ฎ๐ง๐ ๐ข๐ง ๐ญ๐ก๐ž ๐ฉ๐ก๐š๐ซ๐ฆ๐š๐œ๐ž๐ฎ๐ญ๐ข๐œ๐š๐ฅ ๐ข๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ฒ: ๐ฆ๐ž๐๐ข๐š๐ง ๐จ๐ฏ๐ž๐ซ๐š๐ฅ๐ฅ ๐ฌ๐ฎ๐ซ๐ฏ๐ข๐ฏ๐š๐ฅ ๐ข๐ง๐œ๐ซ๐ž๐š๐ฌ๐ž๐ ๐Ÿ๐ซ๐จ๐ฆ ๐Ÿ– ๐ฆ๐จ๐ง๐ญ๐ก๐ฌ ๐ญ๐จ ๐Ÿ๐Ÿ” ๐ฆ๐จ๐ง๐ญ๐ก๐ฌ. ๐“๐ก๐š๐ญ ๐ข๐ฌ ๐ง๐จ๐ญ ๐š ๐ฉ๐จ๐ฌ๐ข๐ญ๐ข๐ฏ๐ž ๐ž๐ง๐จ๐ฎ๐ ๐ก ๐ซ๐ž๐ฌ๐ฎ๐ฅ๐ญ ๐ญ๐ก๐š๐ญ ๐ˆ ๐ฐ๐จ๐ฎ๐ฅ๐ ๐ž๐ฑ๐ฉ๐ž๐œ๐ญ๐ž๐ ๐ฐ๐ข๐ญ๐ก ๐ˆ๐• ๐•๐ข๐ญ๐š๐ฆ๐ข๐ง ๐‚, ๐›๐ฎ๐ญ ๐ข๐ญ ๐ซ๐ž๐Ÿ๐ฅ๐ž๐œ๐ญ๐ฌ ๐ญ๐ก๐ž ๐š๐๐ฏ๐š๐ง๐œ๐ž๐ ๐ฌ๐ญ๐š๐ ๐ž ๐จ๐Ÿ ๐ญ๐ก๐ž ๐œ๐š๐ง๐œ๐ž๐ซ ๐š๐ง๐ ๐ญ๐ก๐ž ๐ฉ๐š๐ญ๐ข๐ž๐ง๐ญ๐ฌ’ […]

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BLA: Transforming Data into Regulatory Success

Posted by Michael A. S. Guth on November 7th, 2025

๐‚๐Œ๐‚ ๐‘๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฒ ๐’๐ญ๐ซ๐š๐ญ๐ž๐ ๐ฒ ๐ข๐ง ๐š ๐ง๐ฎ๐ญ๐ฌ๐ก๐ž๐ฅ๐ฅ: ๐ˆ๐ญ’๐ฌ ๐ญ๐ก๐ž ๐š๐ซ๐ญ ๐จ๐Ÿ ๐ญ๐ฎ๐ซ๐ง๐ข๐ง๐  ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ฑ ๐ฆ๐š๐ง๐ฎ๐Ÿ๐š๐œ๐ญ๐ฎ๐ซ๐ข๐ง๐  ๐๐š๐ญ๐š ๐ข๐ง๐ญ๐จ ๐š ๐ฌ๐ญ๐จ๐ซ๐ฒ ๐จ๐Ÿ ๐œ๐จ๐ง๐ญ๐ซ๐จ๐ฅ ๐š๐ง๐ ๐œ๐จ๐ง๐ฌ๐ข๐ฌ๐ญ๐ž๐ง๐œ๐ฒ ๐ญ๐ก๐š๐ญ ๐ซ๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฌ ๐œ๐š๐ง ๐ญ๐ซ๐ฎ๐ฌ๐ญ. ๐…๐จ๐ซ ๐š ๐๐ก๐š๐ฌ๐ž ๐Ÿ‘ ๐›๐ข๐จ๐ฅ๐จ๐ ๐ข๐œ, ๐ญ๐ก๐ข๐ฌ ๐ฆ๐ž๐š๐ง๐ฌ: โœ… ๐…๐ซ๐จ๐ฆ ๐ƒ๐ž๐ฏ๐ž๐ฅ๐จ๐ฉ๐ฆ๐ž๐ง๐ญ ๐ญ๐จ ๐‚๐จ๐ฆ๐ฆ๐ž๐ซ๐œ๐ข๐š๐ฅ: ๐‰๐ฎ๐ฌ๐ญ๐ข๐Ÿ๐ฒ๐ข๐ง๐  ๐ญ๐ก๐ž ๐ฌ๐ก๐ข๐Ÿ๐ญ ๐ญ๐จ ๐š ๐ฏ๐š๐ฅ๐ข๐๐š๐ญ๐ž๐, ๐ฌ๐œ๐š๐ฅ๐š๐›๐ฅ๐ž ๐ฉ๐ซ๐จ๐œ๐ž๐ฌ๐ฌ ๐ฐ๐ข๐ญ๐ก ๐š ๐ฌ๐œ๐ข๐ž๐ง๐œ๐ž-๐›๐š๐œ๐ค๐ž๐ ๐œ๐จ๐ฆ๐ฉ๐š๐ซ๐š๐›๐ข๐ฅ๐ข๐ญ๐ฒ ๐ฉ๐ฅ๐š๐ง. โœ… ๐๐ฎ๐ข๐ฅ๐๐ข๐ง๐  ๐ญ๐ก๐ž ๐‚๐จ๐ง๐ญ๐ซ๐จ๐ฅ ๐๐š๐ซ๐ซ๐š๐ญ๐ข๐ฏ๐ž: […]

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New Biologics License Application (BLA) Paved with CMC

Posted by Michael A. S. Guth on November 7th, 2025

๐“๐ก๐ž ๐ฉ๐š๐ญ๐ก ๐ญ๐จ ๐š ๐ฌ๐ฎ๐œ๐œ๐ž๐ฌ๐ฌ๐Ÿ๐ฎ๐ฅ ๐๐‹๐€ ๐Ÿ๐จ๐ซ ๐š ๐›๐ข๐จ๐ฅ๐จ๐ ๐ข๐œ ๐ข๐ฌ ๐ฉ๐š๐ฏ๐ž๐ ๐ฐ๐ข๐ญ๐ก Chemistry, Manufacturing, and Controls (๐‚๐Œ๐‚) ๐๐ž๐ญ๐š๐ข๐ฅ๐ฌ. ๐€๐ฌ ๐š ๐‚๐Œ๐‚ ๐‘๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฒ ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ข๐ฌ๐ญ, ๐ฆ๐ฒ ๐Ÿ๐จ๐œ๐ฎ๐ฌ ๐ข๐ฌ ๐จ๐ง ๐š๐ง๐ญ๐ข๐œ๐ข๐ฉ๐š๐ญ๐ข๐ง๐  ๐š๐ง๐ ๐š๐๐๐ซ๐ž๐ฌ๐ฌ๐ข๐ง๐  ๐ก๐ž๐š๐ฅ๐ญ๐ก ๐š๐ฎ๐ญ๐ก๐จ๐ซ๐ข๐ญ๐ฒ ๐œ๐จ๐ง๐œ๐ž๐ซ๐ง๐ฌ ๐›๐ž๐Ÿ๐จ๐ซ๐ž ๐ญ๐ก๐ž๐ฒ ๐›๐ž๐œ๐จ๐ฆ๐ž ๐ช๐ฎ๐ž๐ฌ๐ญ๐ข๐จ๐ง๐ฌ. ๐“๐ฐ๐จ ๐œ๐ซ๐ข๐ญ๐ข๐œ๐š๐ฅ ๐š๐ซ๐ž๐š๐ฌ ๐จ๐Ÿ๐ญ๐ž๐ง ๐๐ž๐Ÿ๐ข๐ง๐ž ๐ญ๐ก๐ž ๐ฌ๐ฎ๐œ๐œ๐ž๐ฌ๐ฌ ๐จ๐Ÿ ๐š ๐›๐ข๐จ๐ฅ๐จ๐ ๐ข๐œ ๐ฌ๐ฎ๐›๐ฆ๐ข๐ฌ๐ฌ๐ข๐จ๐ง: 1. The Comparability Protocol:ย A well-defined comparability protocol […]

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