Thermo Fisher Scientific

Articles

Biologics—including vaccines, cell and gene therapies, monoclonal antibodies (mAbs), and their biosimilars—have great potential for the treatment and prophylaxis of a broad range of diseases. But, rapid and efficient development of new and effective biologics is no easy feat. With such drastic implications for time and resources, it is imperative that biologic manufacturers choose the right commercial collaborators from the start—agile partners who can improve predictivity, speed, and consistency to bridge basic and clinical research. 

QualTrak Real-Time PCR and Digital PCR Ecosystem for Streamlined Biologics Development (June 2023)

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

This case study summarizes the outcomes of several media optimization projects and how the results helped manufacturers to achieve their desired scale-up goals, including enhancing productivity, maintaining product quality, and potentially improving return on investment (ROI).

Custom Traditional and Multi-Omics Media Development Enhances Antibody Production in CHO Cells

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

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 (Apr 2023)

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.	