Quality – Talk Bio

The Perfect Storm: Why 2025 Will Be the Year of GxP AI in Pharma

2 months ago talkbio0Tagged Administration occupational activities, Aortic Valve Insufficiency, data-driven innovation, Drug Development, GxP, pharmaceutical manufacturing, Quality, regulatory

GxP AI, pharmaceutical manufacturing, regulatory compliance, data-driven innovation, quality management, drug development

FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

2 months ago talkbio0Tagged alpha 1-antitrypsin, Chengdu, Chinese Language, Dosage Forms, Failed, import alert, innovation, Inspection (procedure), manufacturers, Quality, Science of Chemistry, United States Food and Drug Administration, Wuhu

FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical

Novo Nordisk Invests $409M in New Quality Control Lab in Denmark

5 months ago talkbio0Tagged Biotechnology, Denmark, Dosage Forms, Nordisk, Quality

Novo Nordisk, quality control lab, Denmark, pharmaceutical investment, biotechnology

Advancements in Hematology: Shaping the Future of Blood Disorder Diagnosis and Treatment

5 months ago talkbio0Tagged Anemia, Sickle Cell, Clinical Practice Guideline, gene therapy, Hematological Disease, Hematology (discipline), Improvement, Quality

Hematology, Blood Disorders, Sickle Cell Disease, Gene Therapy, Clinical Guidelines, Quality Improvement

FDA Raises Sterility and Quality Concerns at Mark Cuban’s Dallas Drug Compounding Facility

6 months ago talkbio0Tagged concerns, Cost Plus, Cuban, Dallas, Dallas facility, Infertility, Massive, Quality, United States Food and Drug Administration

Mark Cuban, Cost Plus Drugs, FDA, sterility concerns, quality issues, drug compounding, Dallas facility

Mitigating Risks in mRNA Manufacturing: Strategies for Smooth Transition from Preclinical to Clinical Stages

6 months ago talkbio0Tagged analytical method, Automation, bony process, clinical transition, Control Groups, Materials, Preclinical, Quality, regulatory, Risk Management, RNA, Messenger

mRNA manufacturing, risk management, preclinical to clinical transition, quality control, regulatory compliance, raw material selection, process automation, analytical methods.