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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
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United-states , American , Kenneth-farrugia , Ester-lovsin-barle , Jove-graham , Ralph-basile , Jessica-graham , Mallory-degennaro , Jayen-diyora , David-dolan , Andreas-flueckiger , Spiro-megremis

RNA Interference With Zilebesiran for Mild to Moderate Hypertension

This phase 2 randomized trial examines the antihypertensive efficacy and safety of different zilebesiran dosing regimens.

Ukraine , Chicago , Illinois , United-states , Cambridge , Cambridgeshire , United-kingdom , Pennsylvania , Canada , Philadelphia , University-of-chicago , Helsinki

Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety

Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
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California , United-states , San-diego , Switzerland , Swiss , Theo-zacharatos , Amanda-mcfarland , York-university , Valsource-inc , Parenteral-drug-association , University-of-florida , Regulatory-affairs

How do cell therapy manufacturers ensure quality in critical raw materials?

This article explores the quality control practices in place for cell therapy manufacturers when usingcritical raw materials.

Aimee-molineux , European-committee-for-standardization , International-conference-on-harmonization , Laboratory-standards-institute , Sponsored-content , European-directorate , International-conference , Sample-curve , Analytical-procedures-text , Confirmation-assay , European-committee , Vitro-diagnostic-reagents

1 Day Online Process Validation Guidance Requirements Course: Focus on FDA and EU Annex 15: Qualifications and Validation

1 Day Online Process Validation Guidance Requirements Course: Focus on FDA and EU Annex 15: Qualifications and Validation
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Dublin , Ireland , Maryland , United-states , Baltimore , Barrya-friedman , Laura-wood , Union-carbide , Ohio-state-university-in-microbiology , E-st-office-hours-call , Office-hours-call , American-cyanamid

Control of external contaminants during CGT materials production

The quality of materials and reagents used in Cell and Gene Therapy (CGT) production processes plays avital role in determining both the product quality as well as therapeutic safety, and external contaminantsmust be strictly controlled.

Aimee-molineux , Chapters , National-institute-for-biological-standards , Drug-administration , European-medicines-agency , International-conference-on-harmonization , Sponsored-content , Gene-therapy , Tissue-engineered-products , Biological-origin , Gene-therapy-medicinal-products , European-collection

Vivani Medical Provides Business Update and Reports Third Quarter Financial Results

Vivani Medical Provides Business Update and Reports Third Quarter Financial Results
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California , United-states , Australia , State-of-california , Australian , Sean-leous , Donald-dwyer , Bydureon-bcise , Adam-mendelsohn , Drug-administration , Nasdaq , Vivani-medical-inc

SciTech Readies for First-In-Human Trial with Clinical Supply of ST-001 nanoFenretinide

SciTech Readies for First-In-Human Trial with Clinical Supply of ST-001 nanoFenretinide
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David-schaffer , Prnewswire-scitech , Earle-holsapple , International-conference-on-harmonization , Scitech-development , Delivery-platform , United-states-pharmacopeia , International-conference , New-drug , Orphan-drug , T-cell-lymphomas ,

Cannabix's MSBS Marijuana Breathalyzer Technology Advances

VANCOUVER, British Columbia, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Cannabix Technologies Inc. (CSE: BLO) (OTC PINK: BLOZF) (the “Company or Cannabix”)...

Vancouver , British-columbia , Canada , United-kingdom , Geneva , Genè , Switzerland , British , Rav-mlait , Drug-enforcement-administration , International-conference-on-harmonisation , International-conference-on-harmonization

SciTech Readies for First-In-Human Trial with Clinical Supply of ST-001 nanoFenretinide

/PRNewswire/ --.SciTech announced today that it has successfully manufactured the clinical supply of its lead drug candidate, ST-001 nanoFenretinide, to...

David-schaffer , Earle-holsapple , Prnewswire-scitech , Scitech-development , International-conference-on-harmonization , Delivery-platform , United-states-pharmacopeia , International-conference , New-drug , Orphan-drug , T-cell-lymphomas ,