BioTech 365
MARCH 10, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: PCR-test reveals risk of genotoxity of genome editing. from European Biotechnology – first and foremost in European biotech [link].
Medical Xpress
FEBRUARY 3, 2023
Fraunhofer researchers have succeeded in using the bioresorbable silica gel Renacer to produce an electrospun membrane that is neither cytotoxic to cells nor genotoxic.
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XTalks
JUNE 21, 2024
The ban, endorsed by member states in April 2024, follows scientific research indicating harmful chemicals in smoke flavorings. The ban targets artificial smoke flavorings linked to genotoxicity concerns. Genotoxicity involves damage to genetic material within cells, increasing cancer and inherited disease risks.
Camargo
DECEMBER 22, 2021
Pediatric Research Equity Act (PREA) Requirements. A nonclinical safety evaluation program typically includes pharmacology, general toxicity, toxicokinetics, nonclinical PK, reproductive toxicity, genotoxicity, and carcinogenesis. Nonclinical Requirements. Chemistry, Manufacturing, and Controls (CMC) Strategies.
The Pharma Data
MARCH 8, 2021
The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies. About Molnupiravir.
Pharmaceutical Technology
JUNE 26, 2022
Placing traditionally siloed drug substance and drug product development activities within a single organization that also has commercial manufacturing capabilities accelerates clinical development and builds in quality and robustness of supply.
XTalks
MAY 13, 2022
Curia is a global contract research, development and manufacturing organization (CDMO) that specializes in drug discovery, spanning the entire product lifecycle from target to lead candidate identification, development, manufacturing feasibility, through to commercialization and post-marketing. Analytical Instrumentation.
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