werden. Der Guanylatzyklase-Aktivator Vericiguat induziert eine Vasodilatation durch direkte Stimulierung des Vasodilatators cGMP in einer Stickstoffoxid-mimetischen Weise. Ein Anstieg von cGMP kann auch die Verformbarkeit der Erythrozyten verbessern. Ein weiterer
December 29, 2024 at 4:27 PM
werden. Der Guanylatzyklase-Aktivator Vericiguat induziert eine Vasodilatation durch direkte Stimulierung des Vasodilatators cGMP in einer Stickstoffoxid-mimetischen Weise. Ein Anstieg von cGMP kann auch die Verformbarkeit der Erythrozyten verbessern. Ein weiterer
+++Breaking #Homöopathie News+++
Die Schweizer Pharmafirma Similasan AG hat wegen groben cGMP Verstößen nach einer Inspektion durch die FDA einen Warning Letter erhalten. So wurde u.a. ein Importstopp für ihre homöopathischen Augentrofen verhängt.
www.fda.gov/inspections-...
Die Schweizer Pharmafirma Similasan AG hat wegen groben cGMP Verstößen nach einer Inspektion durch die FDA einen Warning Letter erhalten. So wurde u.a. ein Importstopp für ihre homöopathischen Augentrofen verhängt.
www.fda.gov/inspections-...
Similasan AG - 658878 - 09/11/2023
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
www.fda.gov
September 23, 2023 at 6:49 AM
+++Breaking #Homöopathie News+++
Die Schweizer Pharmafirma Similasan AG hat wegen groben cGMP Verstößen nach einer Inspektion durch die FDA einen Warning Letter erhalten. So wurde u.a. ein Importstopp für ihre homöopathischen Augentrofen verhängt.
www.fda.gov/inspections-...
Die Schweizer Pharmafirma Similasan AG hat wegen groben cGMP Verstößen nach einer Inspektion durch die FDA einen Warning Letter erhalten. So wurde u.a. ein Importstopp für ihre homöopathischen Augentrofen verhängt.
www.fda.gov/inspections-...
This is super important reporting. However, cGMP isn’t just a phrase, it’s a set of standards set by FDA that manufacturers adhere to to ensure safety is met. www.fda.gov/drugs/pharma...
Facts About the Current Good Manufacturing Practices (CGMP)
It’s a fact! Current Good Manufacturing Practices (CGMP) help to establish the foundation for quality pharmaceuticals through regulatory standards.
www.fda.gov
August 12, 2025 at 12:15 PM
This is super important reporting. However, cGMP isn’t just a phrase, it’s a set of standards set by FDA that manufacturers adhere to to ensure safety is met. www.fda.gov/drugs/pharma...
Cyclase-generated 3',5'-cGMP activates PucsarTIR antiphage defense through a stepwise zig-zag aligned filament assembly https://www.biorxiv.org/content/10.64898/2026.08.12.744502v1
August 14, 2026 at 11:20 AM
Cyclase-generated 3',5'-cGMP activates PucsarTIR antiphage defense through a stepwise zig-zag aligned filament assembly https://www.biorxiv.org/content/10.64898/2026.08.12.744502v1
ロドプシングアニル酸シクラーゼと改変型 cGMP作動性 K⁺ チャネルを用いた神経抑制型オプトジェネティクス🌟
Optogenetic silencing using rhodopsin-GC and engineered cGMP-gated K+ channels🌟
www.science.org/doi/10.1126/...
@johvierock.bsky.social #OpenAccess
Optogenetic silencing using rhodopsin-GC and engineered cGMP-gated K+ channels🌟
www.science.org/doi/10.1126/...
@johvierock.bsky.social #OpenAccess
November 29, 2025 at 7:14 AM
ロドプシングアニル酸シクラーゼと改変型 cGMP作動性 K⁺ チャネルを用いた神経抑制型オプトジェネティクス🌟
Optogenetic silencing using rhodopsin-GC and engineered cGMP-gated K+ channels🌟
www.science.org/doi/10.1126/...
@johvierock.bsky.social #OpenAccess
Optogenetic silencing using rhodopsin-GC and engineered cGMP-gated K+ channels🌟
www.science.org/doi/10.1126/...
@johvierock.bsky.social #OpenAccess
... SIGHS.
You cannot produce medical product manufacturing facilities out of thin air in months.
It takes YEARS to bring a new facility online and producing medications or medical devices.
It takes Millions (or billions) of dollars, and Years of time to build a CGMP compliant plant.
You cannot produce medical product manufacturing facilities out of thin air in months.
It takes YEARS to bring a new facility online and producing medications or medical devices.
It takes Millions (or billions) of dollars, and Years of time to build a CGMP compliant plant.
February 14, 2025 at 9:02 PM
... SIGHS.
You cannot produce medical product manufacturing facilities out of thin air in months.
It takes YEARS to bring a new facility online and producing medications or medical devices.
It takes Millions (or billions) of dollars, and Years of time to build a CGMP compliant plant.
You cannot produce medical product manufacturing facilities out of thin air in months.
It takes YEARS to bring a new facility online and producing medications or medical devices.
It takes Millions (or billions) of dollars, and Years of time to build a CGMP compliant plant.
Posting happy memories today because I can.
First semester in a simulated cGMP lab facility! Took this selfie because my mom insisted to know what it looked like to be Lab Safe in a biomanufacturing setting.
I love being in the lab even if I look like a lunch lady 🧪
First semester in a simulated cGMP lab facility! Took this selfie because my mom insisted to know what it looked like to be Lab Safe in a biomanufacturing setting.
I love being in the lab even if I look like a lunch lady 🧪
November 7, 2024 at 12:11 AM
Posting happy memories today because I can.
First semester in a simulated cGMP lab facility! Took this selfie because my mom insisted to know what it looked like to be Lab Safe in a biomanufacturing setting.
I love being in the lab even if I look like a lunch lady 🧪
First semester in a simulated cGMP lab facility! Took this selfie because my mom insisted to know what it looked like to be Lab Safe in a biomanufacturing setting.
I love being in the lab even if I look like a lunch lady 🧪
'Using a genome-wide in vivo CRISPR screen, we identified phosphodiesterase 5 & its substrate cGMP as key modulators of DC migration. Advanced tumours disrupted cGMP synthesis in DCs to decrease their motility, while PDE5 perturbation preserved the cGMP pool to restore DC migration'
#TumorImmunology
#TumorImmunology
Rescuing dendritic cell interstitial motility sustains antitumour immunity - Nature
Disruption of dendritic cell (DC) interstitial motility in the tumour microenvironment promotes immune evasion, and enhancement of DC interstitial motility offers a route for DC-centric immunotherapy.
www.nature.com
July 2, 2025 at 12:29 AM
'Using a genome-wide in vivo CRISPR screen, we identified phosphodiesterase 5 & its substrate cGMP as key modulators of DC migration. Advanced tumours disrupted cGMP synthesis in DCs to decrease their motility, while PDE5 perturbation preserved the cGMP pool to restore DC migration'
#TumorImmunology
#TumorImmunology
And _even if it wasn't_, that would not be argument against DIY, if access to pharma quality CGMP-compliant HRT is being removed.
Because the alternative is detransition, and that has a body count too.
Because the alternative is detransition, and that has a body count too.
June 16, 2026 at 6:41 PM
And _even if it wasn't_, that would not be argument against DIY, if access to pharma quality CGMP-compliant HRT is being removed.
Because the alternative is detransition, and that has a body count too.
Because the alternative is detransition, and that has a body count too.
@altfda.altgov.info FDA warning letter to Abbott Labs re: much hyped wearable glucose monitors. Hello RFK Jr
Abbott Diabetes Care, Inc. - 722046 - 01/23/2026
CGMP/QSR/Medical Devices/Adulterated
www.fda.gov
February 3, 2026 at 7:00 PM
@altfda.altgov.info FDA warning letter to Abbott Labs re: much hyped wearable glucose monitors. Hello RFK Jr
March 15, 2024 at 8:09 PM
"[Moderna] said all product released by the company was tested and meets product specifications and international regulatory requirements."
you can't test into cGMP compliance!
you can't test into cGMP compliance!
I’m kind of surprised I haven’t seen anyone talking about this, but maybe bluesky isn’t the right crowd
FDA finds control lapses at Moderna manufacturing plant www.reuters.com/business/hea...
FDA finds control lapses at Moderna manufacturing plant www.reuters.com/business/hea...
reuters.com
www.reuters.com
December 22, 2023 at 3:28 AM
"[Moderna] said all product released by the company was tested and meets product specifications and international regulatory requirements."
you can't test into cGMP compliance!
you can't test into cGMP compliance!
in fairness to the courts, i guess, the statutory definition of "adulterated" includes drugs that were not made in compliance with CGMP (current good manufacturing practices). so a drug can be statutorily "adulterated" but not actually "adulterated" in the vernacular sense. but still, come on
August 17, 2026 at 2:31 PM
in fairness to the courts, i guess, the statutory definition of "adulterated" includes drugs that were not made in compliance with CGMP (current good manufacturing practices). so a drug can be statutorily "adulterated" but not actually "adulterated" in the vernacular sense. but still, come on
If you ever doubt the need for the FDA, go to their website and read their warning letters and their inspection findings. I worked in medical devices for 15 years and shit is wild. Here's my personal favorite of all time: a pharma lab running an unlicensed brewery in the back:
October 26, 2024 at 12:57 AM
If you ever doubt the need for the FDA, go to their website and read their warning letters and their inspection findings. I worked in medical devices for 15 years and shit is wild. Here's my personal favorite of all time: a pharma lab running an unlicensed brewery in the back:
News from US pharma CMO Veranova - entering the red hot space of bioconjugation:
veranova.com/news/veranov...
veranova.com/news/veranov...
Veranova Announces Strategic Investment to Establish cGMP Bioconjugation Capability in Devens, MA | Veranova
veranova.com
June 16, 2025 at 4:38 PM
News from US pharma CMO Veranova - entering the red hot space of bioconjugation:
veranova.com/news/veranov...
veranova.com/news/veranov...
Optogenetic silencing by combining a rhodopsin cyclase with an engineered cGMP-gated potassium channel www.science.org/doi/full/10....
July 15, 2026 at 12:40 PM
Optogenetic silencing by combining a rhodopsin cyclase with an engineered cGMP-gated potassium channel www.science.org/doi/full/10....
It’s infuriating, especially with bird flu looming. Vaccines, fluoride, pasteurization, sunscreen, hand-washing with soap, N95 masks, and drugs proven to be safe and effective and manufactured under cGMP will all come under attack.
November 13, 2024 at 3:44 PM
It’s infuriating, especially with bird flu looming. Vaccines, fluoride, pasteurization, sunscreen, hand-washing with soap, N95 masks, and drugs proven to be safe and effective and manufactured under cGMP will all come under attack.
HEILIGE MUTTER MARIA DER CGMP
was geht denn ab 😆
was geht denn ab 😆
June 30, 2026 at 8:53 AM
HEILIGE MUTTER MARIA DER CGMP
was geht denn ab 😆
was geht denn ab 😆
'Your unapproved ophthalmic drug products are especially concerning from a public health perspective, particularly given your firm’s significant violations of CGMP regulations. Ophthalmic drug products [...]' Wie die dir FDA mitteilt, dass sie äußerst unzufrieden mit deiner Arbeit ist. 😂
+++Breaking #Homöopathie News+++
Die Schweizer Pharmafirma Similasan AG hat wegen groben cGMP Verstößen nach einer Inspektion durch die FDA einen Warning Letter erhalten. So wurde u.a. ein Importstopp für ihre homöopathischen Augentrofen verhängt.
www.fda.gov/inspections-...
Die Schweizer Pharmafirma Similasan AG hat wegen groben cGMP Verstößen nach einer Inspektion durch die FDA einen Warning Letter erhalten. So wurde u.a. ein Importstopp für ihre homöopathischen Augentrofen verhängt.
www.fda.gov/inspections-...
Similasan AG - 658878 - 09/11/2023
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
www.fda.gov
September 23, 2023 at 7:05 AM
'Your unapproved ophthalmic drug products are especially concerning from a public health perspective, particularly given your firm’s significant violations of CGMP regulations. Ophthalmic drug products [...]' Wie die dir FDA mitteilt, dass sie äußerst unzufrieden mit deiner Arbeit ist. 😂
The warning letter I was quoting can be found here: www.fda.gov/inspections-...
Cue Health, Inc. - 675673 - 05/09/2024
CGMP/QSR/Medical Devices/Adulterated
www.fda.gov
May 14, 2024 at 1:53 AM
The warning letter I was quoting can be found here: www.fda.gov/inspections-...
How well we remember that…we actually had S protein made in plants by early Feb as a putative vaccine. Doesn’t help when your entire country doesn’t have a cGMP pilot plant to MAKE the damn thing!
December 27, 2024 at 8:22 AM
How well we remember that…we actually had S protein made in plants by early Feb as a putative vaccine. Doesn’t help when your entire country doesn’t have a cGMP pilot plant to MAKE the damn thing!
This is not the first time this distributor has been cited by the fda for rodent contamination and other unsanitary conditions. From 2018: 🤢
www.fda.gov/inspections-...:
www.fda.gov/inspections-...:
Gold Star Distrbution., Inc. - 562931 - 10/19/2018
Gold Star Distrbution., Inc., CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
www.fda.gov
December 30, 2025 at 10:00 PM
This is not the first time this distributor has been cited by the fda for rodent contamination and other unsanitary conditions. From 2018: 🤢
www.fda.gov/inspections-...:
www.fda.gov/inspections-...: