Biomanufacturing Featured Articles
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Genome Editing Using mRNA-Lipid Nanoparticles For CAR T Cell Therapy
11/22/2023
Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.
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Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
11/20/2023
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
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Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
11/16/2023
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
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Start Pharma 4.0: Examples To Advance Ultra-Cold Storage Of Drug Substances
11/15/2023
See how adopting the standardized and fully automated processes of Industry 4.0 can contribute to your cost efficiency, patient safety, and sustainability in pharmaceutical manufacturing.
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Achieving Speed And Scale With Optimized Synthesis Solutions
11/15/2023
Realize optimal coupling efficiency and increase your productivity for oligonucleotide drugs by selecting the right synthesizer and prioritizing automation to define and tweak synthesis methods.
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Ready To Amplify Plasmid (pDNA) In Bacteria?
11/14/2023
Explore how to use and amplify pDNA from the development of recombinant proteins and viral vectors to advanced bio-therapeutics such as mRNA vaccines.
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1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next
10/30/2023
The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
10/25/2023
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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Key Takeaways Of Annex 1: What It Means For Your Cold Chain Management
10/19/2023
What are the practical implications of the latest Annex 1 update, specifically for cold chain management?
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Challenges In Viral Vector Production & Innovative Solutions
10/18/2023
Single-use technology is playing a large role in increasing flexibility and reducing contamination risks for the biopharmaceutical industry. Take a deeper look into all of the advantages and challenges.