Thermo Fisher Scientific

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.

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.

When evaluating a potential vendor, whether for a catalog medium or custom formulation manufacturing, it is important to ensure it can meet your unique needs. This article details five top considerations to carefully evaluate when selecting a cell culture media supplier. Learn how to maximize confidence in your media supply, optimize productivity and help achieve long-term efficiency.

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.

Explore QualTrak to find the right bioanalytical tools by modality, phase, and applications. Optimize biopharmaceutical drug development with suggested efficient workflows supported by consistent assays & reagents manufactured under GMP manufacturing principles, automated instruments, premium service & support, and a vertically integrated supply chain. The Applied Biosystems family of most-cited qPCR solutions is designed to simplify your process and expedite your results. Stop wasting your time in page hopping to find bioanalytical tools. And check out this once centralized location for qPCR, dPCR & CE workflows!

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).

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.

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.

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.

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.

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:

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

Learn how Gibco™ Rapid Prototyping can help idenitfy the most feasible cell culture media for cGMP scale-up.

This session will address ways to help streamline media manufacturing, including rapid, small-scale non-cGMP media prototyping and proprietary media formulation outsourcing options.

How to achieve robust and consistent high-quality productivity for successful commercial manufacturing is dependent on clearly defining your criteria for successful scale-up. This article explains how using a fully optimized cell culture medium, and identifying it early in the development process, should be part of the criteria as they can avoid time-consuming and costly redevelopment at scale-up.

This brochure presents Gibco™ products and dedicated support services backed by a robust global manufacturing network to help you scale up your AAV manufacturing workflow with confidence and meet your project goals

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.

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?

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.

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.

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).

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.

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.

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.

Automated HPLC method development and robustness tests for abacavir, lamivudine, dolutegravir, and their related compounds in Triumeq drug product.

Out-of-the-box usability of Thermo Scientific™ UltiMate™ 3000 and Vanquish Core HPLC instruments for the compendial analysis of commonly prescribed drugs.

Development of a robust LC method for metolazone and related impurities using analytical quality by design best practices.

Quality control (QC) testing of pharmaceuticals must be rigorous and involves multiple techniques including GC-MS, LC-MS, IC, and elemental analysis techniques.

Method modernization is often less difficult than the common perception, and good practices can be put in place to streamline and facilitate the process.

A UHPLC method development system for efficient scouting of chromatographic elution parameters.