Thermo Fisher Scientific

Articles

Media manufacturers must offer global redundancy at harmonized manufacturing facilities to enable streamlined capabilities–especially for their customers outsourcing proprietary cell culture media formulations. This paper details Thermo Fisher’s manufacturing equivalency approach utilized at two global facilities located in Miami, Florida, and Grand Island, New York.  

Reducing Risk in Bioproduction with Facilities Equivalency (Jan 2024)

The importance of successfully scaling up cell culture media cannot be overstated. Not starting the process soon enough can introduce issues with solubility, manufacturability, procurement, and cost management. This article considers technical and commercial best practices that drug developers may enact so that they, their suppliers and media manufacturers, and in turn, their cell culture media remain on the most efficient path to market.

Accelerating Cell Culture Media Manufacturing From Rapid Prototyping Through cGMP (Jan 2024)

In this project, Thermo Fisher Scientific worked with a multinational biopharmaceutical company to investigate trace element variability in its custom cell culture media. Within a year, using a risk-based, collaborative approach, both teams were able to thoroughly characterize incoming specific raw materials and implement proactive measures for reducing the risk of impurities, ultimately providing the company with a long-term risk mitigation strategy.		

A Collaborative Study for Understanding Trace Element Variability in Custom Cell Culture Media (Jan 2024)

Read about the process utilized and results gained from the use of a two-phase scale-up strategy to manufacture three complex dry powder medium (DPM) formulations. The success of these projects relied on consistently producing acceptable prototype and cGMP material within the customer’s specifications and manufacturing timelines.

Successful Manufacturing of Dry Powder Media From Development to Large-Scale cGMP Production: A Two-Phase Strategy (Jan 2024)

 Biotech, BioPharma’s, CDMOs, CROs who are investigating promising nucleic acid-based drug candidates like vaccines, mAbs, and other biologics & biosimilars must go through stringent quality control checks for their molecular entities to ensure safety & efficacy of their drug candidates. Explore the best quality control workflows using QualTrak qPCR ecosystems. Learn more inside this eBook about the benefits of:


Real-Time PCR & Digital PCR in QC of Biopharmaceutical Discovery & Development

Learn how Gibco™ Rapid Prototyping can accelerate your journey to cGMP