Aldevron Breakthrough Blog: Clinical Grade Manufacturing/cGMP

The Benefits of Streamlining and Standardizing Plasmid DNA for Cell and Gene Therapies

Manufacturing standardization for cell and gene therapies (C&GT) has received increased focus in the last several years, spurred by the rapid exponential growth witnessed in this field. The resulting need for improved access to high-quality raw materials, including plasmid DNA, has made standardization integral to streamlining the development process for this biologic product category. 
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Applying Experience - Partnering with Pioneers to Deliver Plasmid for Discovery Through Commercial Application: On Demand Video

Aldevron recently hosted a webinar through FIERCE Biotech titled: Applying Experience - Partnering with Pioneers to Deliver Plasmid for Discovery Through Commercial Application.

Listen below to hear featured presentations from Cindy Biffert, VP of GMP Nucleic Acids Business Unit at Aldevron, Barry Byrne, M.D, P.h.D, Associate Chair of Pediatrics and Professor at UFL, Director of Powell Gene Therapy Center, and Earl and Christy Powell University Chair in Genetics, and Christine Sheaffer, Manufacturing Operations Lead at Spark Therapeutics. 

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The Pivotal Role of Plasmid DNA

Plasmid DNA has historically been 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 our nearly 23 years of plasmid DNA manufacturing expertise, Aldevron has helped facilitate the advance of these important therapeutics. We continue to invest in additional capacity and novel capabilities to support biopharma manufacturers into the future.
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Plasmid DNA Insights: Expanded Focus on CMC in Gene & Cell Therapy Development

Aldevron recently hosted a webinar through Endpoints news titled: Plasmid DNA Insights: Expanded Focus on CMC in Gene and Cell Therapy Development.

Arsalan Arif, the publisher and founder of Endpoints News moderated the well-balanced, industry expert guest panel featuring Dr. Anthony Davis, Chief Executive of Dark Horse Consulting, Ken Bonnell, SVP of Quality and Regulatory at Aldevron; Biswarup Dasgupta, Director of Quality Assurance at Sarepta; and Frank Bonnelly, Director of Supply Chain at Encoded.

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Evaluating Quality Systems with Your Manufacturing Partners

A common question we receive from clients is how to evaluate a new manufacturer's quality system, and how to verify that it complies with global regulatory bodies' prescribed guidance, especially since the landscape surrounding regulatory guidance is constantly changing as the cell and gene therapy industry evolves.

Luckily, I was fortunate enough to sit down with Ken Bonnell, Aldevron’s Senior Vice President of Quality and Regulatory Affairs, to learn more about how to evaluate manufacturing partners, what to look for, and what is important. You can continue to read our conversation in this article or listen by checking out the video below!

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Virtual Facility Audits Now Available

Challenging times require creative solutions. Especially now, when in-person contact is discouraged yet first-hand, observed information is critical, we all depend on fresh ways to think about how we provide access and insight.

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