Aldevron News: Gene Therapy

Plasmid DNA Insights: Expanded Focus on CMC in Gene & Cell Therapy Development

Gene and cell therapy developers are contending with the implications of the evolving regulatory environment while trying to progress programs as quickly as possible to address unmet needs and secure first-mover advantage in competitive indications. Regulators are facilitating efforts to truncate development timelines through a series of designations that can expedite programs while also making efforts to implement standardization.

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In the News: Pharma's Almanac - The Pivotal Role of Plasmid DNA

Plasmid DNA was key to the development of biologic drug manufacturing. Today, it plays a critical role in the production of next-generation cell and gene therapies and vaccines. With its plasmid DNA manufacturing expertise, Aldevron has helped facilitate the advance of these important therapeutics. The company continues to invest in additional capacity and novel capabilities to support biopharma manufacturers into the future.

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Genprex Taps Aldevron to Enable Full Commercial Scale Plasmid DNA Manufacturing Capabilities

Genprex, Inc. (NASDAQ: GNPX), is collaborating with Aldevron to secure GMP plasmid DNA manufacturing capacity for Genprex's Oncoprex™ gene therapy portfolio.

The manufacturing program supports upcoming clinical trials, including Oncoprex™ in combination with Tagrisso®, which has received FDA Fast Track Designation. The collaboration with Aldevron will enable full commercial scale plasmid DNA manufacturing capabilities. 

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Aldevron, Nature Technology Corporation Team up to Offer Nanoplasmids™ for Gene Therapy Manufacturing

Aldevron has announced the immediate availability of NanoplasmidsTM and antibiotic-free RNA-OUT technology for use in gene therapy manufacturing. Through a license agreement with Nature Technology Corporation (NTC), Aldevron can now provide its clients the option of using NTC’s plasmid technology to provide a more efficient system for manufacturing viral vectors used in gene and cell therapy.

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Genprex™ Manufacturing Partner Aldevron Completes Significant Step in Manufacturing for Oncoprex™ Clinical Development Program

Newly manufactured plasmids will be used in clinical trials evaluating Oncoprex™ in combination with targeted therapies and immunotherapies

Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, announced that its manufacturing partner, Aldevron, has successfully completed the manufacturing of the TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA pursuant to the manufacturing agreement between Genprex and Aldevron that was announced in September 2018.

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