production – Talk Bio

Vaxcyte Strikes up to $1B Fill-Finish Manufacturing Deal with Thermo Fisher at North Carolina Facility

1 week ago talkbio0Tagged biomanufacturing, commercial supply chain, Manufacturing, North Carolina, PCVs, pneumococcal conjugate vaccines, production, Thermo Fisher Scientific, United States, Vaccines, VAX-24, VAX-31, Vaxcyte

Vaxcyte; Thermo Fisher Scientific; fill-finish manufacturing; North Carolina; pneumococcal conjugate vaccines; PCVs; VAX-31; VAX-24; commercial supply chain; biomanufacturing; U.S. vaccine production; $1 billion deal

Continuous Bioprocessing for Bispecific Antibodies: Innovations Accelerating Therapeutic Antibody Production (2024–2025)

2 weeks ago talkbio0Tagged Antibodies, Bispecific, antibody engineering, Automation, bioprocess, bioprocessing, Continuous, high-throughput, innovation, oncology therapeutics, production, Protein Purification, scale-up, Therapeutic Antibody

continuous bioprocessing; bispecific antibodies; therapeutic antibody production; bioprocess innovation; high-throughput production; antibody engineering; scale-up; oncology therapeutics; protein purification; automation

FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

3 weeks ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing

Roche injects $550M into Indianapolis hub to scale up CGM production

5 months ago talkbio0Tagged Continuous glucose monitoring, Indianapolis, Investments, Manufacture, production, Roche (company), United States

Indianapolis, Roche (company), Continuous glucose monitoring, production, Manufacture, Investments, United States

Novartis to invest $23B in manufacturing so ‘all key medicines’ can be made in the US

6 months ago talkbio0Tagged Biological Factors, Investments, Manufacture, Novartis, production, United States

Novartis, United States, Investments, Manufacture, production, Biological Factors, Novartis

Novo Nordisk Invests $1.1 Billion to Expand GLP-1 Drug Manufacturing in Brazil

6 months ago talkbio0Tagged Brazil, Claros facility, Diabetes, Glucagon-Like Peptide 1, Investments, Montes, Nordisk, Obesity, Ozempic, pharmaceutical manufacturing, production, Wegovy

Novo Nordisk , GLP-1 production , Brazil investment , Wegovy and Ozempic , Diabetes treatment , Obesity treatment , Montes Claros facility , Pharmaceutical manufacturing

Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA

6 months ago talkbio0Tagged Advanced Manufacturing Technology, Biologics License Application, Cell Shuttle, Cell Therapy, Cellares, Identifier, Investigational New Drugs, production, Technology, United States Food and Drug Administration

Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs