mRNA Technology

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Clinical Induced Pluripotent Stem Cell (iPSC) Reprogramming and Cell Differentiation

Over the past decade Allele Biotechnology has developed and patented (USPTO 10119150, 10155929) its proprietary iPSC reprogramming and differentiation methods that are based on non-integrating mRNA technology to enable the clinical use of iPSCs. mRNA based reprogramming allows for precise stoichiometric control of reagents and yields robust stem cells with unparalleled efficiency.

Our technical team has adapted all of our methods and reagents for cGMP production that is fully compatible with USFDA standards. These methods have been validated in our San Diego cGMP facility and can be used in our facility our out licensed for various projects.

Publications:

Feeder-Free Derivation of Human Induced Pluripotent Stem Cells with Messenger RNA

Feeder‐Free Reprogramming of Human Fibroblasts with Messenger RNA

 
 

cGMP Facility

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cGMP iPSC Production

Current Good Manufacturing Practice (cGMP) is the United States Food and Drug Administration’s (FDA) monitoring program to ensure quality pharmaceuticals manufacturing. cGMP regulations establish minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.

Our 18,000 square foot cGMP facility is located in San Diego at the heart of the biotech sector. It has over 4,000 square feet of clean room space rated up to Class 3 (ISO 5). The facility’s modular design enabled multiple projects to occur simultaneously while ensuring strict adherence to US FDA guidelines.

The space also contains a dedicated QC and Process Development lab to enable protocol adaptation and engineering runs as well as dedicated medical offices for controlled sample collection.

 
 

Opportunities

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Working with Allele

There are a few ways to work with Allele to harness our iPSC reprogramming and differentiation technology along with our clinical development capabilities.

Licensing Existing iPSC Lines

cGMP iPSC lines that have been developed in our San Diego facility are currently available for licensing. These lines are fully consented, documented, qualified and ready for clinical development. Lines can be licensed on an exclusive or non-exclusive basis. Contact us to learn more or receive information about our available iPSC lines.

Custom Manufacturing

Our dedicated scientific staff can work with you to initiate and execute a clinical development and manufacturing plan. Key steps include

  • Technology Transfer for the use of external protocols

  • Process Development

  • Analytical Development

  • Scale Up and further process adaptation

Contact us to learn more about our custom development and manufacturing capabilities.