Aldevron Breakthrough Blog / Aldevron

Why Apply ISO 13485 Principles in a Protein Manufacturing Facility?

A stepping-stone in ongoing quality improvement

The ISO 13485 standard covers the quality management system (QMS) requirements for medical devices (like CT scanners, blood perfusion pumps, diagnostic IVD tests) including requirements for regulatory purposes. Certification is granted by a third-party registrar through an annual audit process with renewal every three years. Unlike global medical device governmental regulations, the ISO 13485 standard is the same whether you are manufacturing in Italy, Africa or the United States.
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Podcast: Insights into the Editing of the Human Genome

Where Can Novel Nonviral Polymeric Delivery Agents Take Us?

Collaboration has always been an important part of scientific research and discovery, especially when you combine the resources of strategic partners in science, clinical, engineering and manufacturing.

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BIO Convention Brings Optimism, Concerns

Timelines and Supply Chains Still Seen as Challenges

BIO International’s annual convention is one of the largest gatherings of biotechnology innovators in the world. The Aldevron team attending this year’s in-person gathering in San Diego observed that the past few years of COVID restrictions haven’t changed the high interest in our industry.

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Unique Perspectives, Unique Opportunities

TIDES USA pivots to RNA technology

We often hear how interest in, and use of, RNA technology is growing because of the COVID-19 pandemic. One discussion at the TIDES USA conference had a unique perspective: how Moore’s Law may now apply to RNA technology.

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Lessons Learned & Looking to the Future

Thoughts from the World Vaccine Congress

Managing the H1N1 outbreak in 2009 was considered a practice run for the recent SARS-CoV2 pandemic and, over the last two years, we certainly learned a great deal in being prepared for the next virus to gain a foothold. That was the backdrop as we returned to the World Vaccine Congress in Washington, DC.

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Seeking Faster Paths to the Clinic

Need for speed emphasized at American Biomanufacturing Summit

The American Biomanufacturing Summit, held in San Francisco in April, is a senior-level event attracting over 200 biopharmaceutical executives sharing the latest information from the industry. One top item consistently discussed was how the expectations of speed have been dramatically changed after how quickly COVID-19 vaccines were developed and moved to market, most particularly the mRNA vaccines.

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Webinar On Demand: mRNA/saRNA Manufacturing - Considerations to Accelerate the Path to Clinic

GEN webinar featuring Dr. Venkata Indurthi, Aldevron Chief Scientific Officer

Messenger RNA (mRNA) and self-amplifying RNA (saRNA) offer a unique opportunity for the development of novel therapeutics to treat a wide range of diseases. These modalities offer distinctive advantages over traditional therapies, from both biological and production standpoints. The success of RNA programs may depend heavily on the timeline to manufacture RNA molecules.

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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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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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