Newsletter | September 29, 2022

09.29.22 -- Accessing In-House Plasmid Production To Secure Supply Chains

In-House Plasmid Production To Secure Supply Chains

Access to plasmid is a significant stumbling block in downstream biopharmaceutical manufacturing; instability in manufacturing, as well as issues identified post-sequencing, are perhaps bigger factors in this problem than capacity, but each are important considerations for companies looking to streamline their development efforts.

The Future Of Viral Vector Manufacturing: Yield Optimization

The ability of viral vectors to target specific cells has made them one of the most promising treatment modalities to emerge in recent years, but the specificity enabled by this tropism has created scale-up complexities. Ensuring optimal yield for engineered viral vectors is crucial to ensuring their eventual commercial viability.

Early Plasmid Optimization For Long-Term Commercial Success

Choosing the right plasmid can help prevent costly delays in the development life cycle. Core to this is selecting a supplier with the quality assurance protocols and good manufacturing practices (GMPs) in place to facilitate optimized plasmid production.

Navigating Analytical Requirements For GMP Viral Vectors

The key to success is establishing appropriate strategies, beginning with fundamental testing, expecting additional regulatory requests, being prepared for assay variability, recognizing the limits of current understanding, and ensuring that comparability studies will be possible by retaining material from preclinical batch runs and stability studies.

The Andelyn Difference

By expediting the development and production of leading-edge therapies, more patients than ever before can now be treated. Andelyn Biosciences supports patients from preclinical through commercial manufacturing.

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Work with Andelyn Biosciences from start to finish of your product or as a partner at any stage of your project — preclinical through commercial scale.

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