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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cultivated foods, grown directly from animal cells, have the potential to drastically decrease negative health and environmental impacts. With large-scale manufacturing and commercialization of such products now possible, one of the main challenges has been the cost of manufacturing customized cell culture growth media. When assessing a media manufacturing, there are five key factors to consider.
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