Biomanufacturing Featured Articles
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Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing
6/12/2023
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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3 Action Items For The US Bio/Pharma Industry To Mitigate Supply Vulnerabilities
6/12/2023
The United States’ reliance on foreign manufacturers of API has been a known fact for several years. We can mitigate our supply vulnerabilities, but bio/pharma companies and the FDA both have roles to fill in this need.
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Will POC Manufacturing Unlock The Value Of Autologous Cell Therapies?
6/5/2023
To shorten the treatment journey for autologous cell therapy patients, a promising model that appears to be emerging is point-of-care (PoC) manufacturing in major cancer and academic medical centers and hospital networks. PoC has the potential to address other ongoing concerns, such as the reduction of risks and costs.
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Can Life Sciences Untangle Tech Transfer?
5/19/2023
Explore the complexities of tech transfer, what is slowing tech transfer down on a commercial level, and the two-pathway approach you can take when adopting digital native tools.
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Let’s Explore Packaging For Aseptic Manufacturing
5/19/2023
When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.
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FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs
5/4/2023
In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. This article summarizes the guidance in a helpful FAQ format.
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SAR – Sequence-Activity Relationships for Efficient Protein Engineering
5/1/2023
As protein-based therapeutics gain traction in the greater market, innovative techniques aimed at their optimization have become a key driver for industry.
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Aldevron Announces Expansion Of mRNA Production Capability
5/1/2023
Aldevron, a leading global manufacturer of DNA, RNA and proteins used in cell and gene therapies and vaccine development, will expand its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities enabling mRNA cGMP manufacturing services from Master Cell Bank through to Drug Product.
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Era Of Post Spray Drying: Fermentation Fluid Management Platform
4/17/2023
If you are looking for an alternative to spray drying for your bulk intermediates, there's a plate-based freezing and thawing system that may provide a controlled and uniform solution.
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4 Risk Mitigation Strategies For mRNA Production
4/17/2023
Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.