Thermo Fisher Scientific
Articles
Straight From the Source: Streamlining Scale-up With Quality Raw Materials
June 19, 2023
As processes increase in scale, the greater raw material volumes and stricter quality requirements can make it challenging to deliver an effective and economically feasible product. In this how-to guide, we discuss the common challenges that developers face when moving through process development and outline the essential steps for streamlining scale-up through effective raw material sourcing.
Format Follows Function: Media Considerations for Future-Proofing AAV Manufacturing Processes
June 19, 2023
Although the potential of gene therapy has been established for decades, it is only in recent years that the industry has seen a major turning point with the first therapies receiving approval in the late 2010s. As the potential of these therapies is realized, the question of the hour is: how do we manufacture AAV gene therapies sustainably in the long term?
QualTrak Real-Time PCR and Digital PCR Ecosystem for Streamlined Biologics Development (June 2023)
June 02, 2023
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.
Successful Manufacturing of Dry Powder Media From Development to Large-Scale cGMP Production: A Two-Phase Strategy
April 26, 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.
Custom Traditional and Multi-Omics Media Development Enhances Antibody Production in CHO Cells
April 26, 2023
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).
Reducing Risk in Bioproduction with Facilities Equivalency
April 26, 2023
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.