Cell Culture Media Manufacturing

Resources for cell culture media manufacturing

Whether you have your own proprietary formulation, are looking to improve performance, or need an additional supplier to offer support, optimizing your media manufacturing should be an essential step in your process. Subscribe to receive additional articles, tips, white papers, and more.

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Scale-up manufacturing

From regulatory considerations and capacity evaluation to optimizing your formulation and format, early assessment of your process can be key to achieving a smooth and economical transition to GMP manufacture. Read on for industry perspectives and support with your roadmap to efficiency and success.

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Article: Vaccine bioproduction: An industry in the spotlight

The emergence of SARS-CoV-2 thrust the vaccine manufacturing industry into the spotlight in 2020. The race to manufacture unprecedented volumes of life-saving vaccines had begun and the bioprocessing industry rapidly responded.

Read about the different vaccine platforms being utilized to prevent the spread of a wide range of pathogens, how vaccine developers have been able to produce vaccines so quickly, and how manufacturers have maintained supply of these vaccines globally.

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Regulatory environment

Podcast: Navigating the biopharmaceutical regulatory environment

The biologics regulatory environment is complex and often requires support and expertise to navigate.

In this podcast, Mike Brewer, Director and Global Principal Consultant, Regulatory for BioProduction and Kasey Kime, Senior Manager of Regulatory Affairs, from Thermo Fisher Scientific, explain key regulatory considerations and how Thermo Fisher can help biologics manufacturers, especially those with proprietary cell culture media formulations, achieve compliance.

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A microscopic view of cells, colored blue

Infographic: What goes into your production media?

Is it best to source animal origin (AO) or animal origin–free components (AOF)? What additional components are available? Which components do I need to enable optimal growth of my specific cell line?

This infographic offers some of the answers to these questions, discusses the benefits and drawbacks of each source, and explores the roles played by different cell culture media components.

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contamination challenges scale up

Article: Raw materials in upstream bioproduction: Challenges and solutions

Cell culture media can directly affect the success of the entire bioproduction process. For this reason, the smooth development, optimization, and manufacture of cell culture media is critical to prevent production delays and unexpected extra costs. Discover solutions to common challenges faced when establishing an efficient cell culture media, including optimizing media chemistry, controlling for impurities, and maintaining consistency. Learn how prioritizing these areas during development could help you achieve consistency throughout your workflow.

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Maintaining GMP consistency

Fundamental to success during GMP manufacturing is consistency. The importance of robust supply chains, high quality raw materials, and an experienced and established partner cannot be understated. Learn how securing these key elements can help keep you on time and on track throughout your bioprocessing journey.

A picture displaying collaboration between individuals

Article: Preparing for the green light: Considerations for post-approval biologic manufacturing

The primary goal of all biopharmaceutical developers is to efficiently get their life-changing therapeutics into clinics to help as many patients as possible. This means that a robust strategy for reliable large-scale commercial manufacture is essential well before initial approval.

Planning your strategy requires a number of considerations, ranging from raw material quality and supply assurance, to both in-house and external manufacturing capacity. This article discusses these further and details additional considerations when developing a successful post-approval manufacturing strategy.

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A picture of clusters of cells

Infographic: The importance of raw materials for protein quality and consistency

The importance of raw materials for protein quality and consistency. When transitioning to commercial manufacture, maintaining consistency of raw materials is vital. Even minor impurities can have a major impact on protein quality attributes and batch-to-batch consistency—ultimately resulting in changes to the safety and efficacy of the end product.

Discover strategies used to maintain end-product consistency during commercial manufacture. Additionally, learn more about the investigatory process required when inconsistency is detected and steps to resolution from a real-life case study.

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A picture of viral cells, colored red

Article: From meeting demand to the new normal: how biologics production is shifting in response to the coronavirus health crisis

SARS-CoV-2 has forced the bioprocessing industry to quickly adapt—developing new vaccines and treatments at a record pace while working to minimize the impact of these rapid changes on other projects. The unprecedented strain on supply chains has impacted all corners of the industry, from clinical development to production, ushering in a number of changes.

As we move quickly from the new normal to the “next normal,” discover what this means for the future of bioprocessing. Read more to learn about the shifting trends and rapid innovation brought on by this health crisis and how the bioprocessing industry has adapted.

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A picture containing bars of a graph, showing growth

Infographic: What’s causing variability in your formulation?

Some raw materials are more commonly associated with variability than others. Knowing which raw materials most commonly contain unexpected trace elements will help to reduce the likelihood of out-of-specification materials causing costly delays to your process. Find out if you have any high-risk raw materials in your formulation and how to successfully characterize them.

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Bioprocessing resources

Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing:

Style Sheet for Global Design System