Aldevron Breakthrough Blog: Quality

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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A Maturing Market

Expectations, oversight and transparency

From the early days of therapeutics development, a common refrain has been that GMP manufacturing takes longer and costs more than expected. This can be traced back to when programs often started in academic laboratories, which then needed substantial analytical and process development as a program moved towards clinical stages.

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Expanding an Analytical Framework

Increased expectations, increased accountability

Rapid evolution. In short, that’s what we’re seeing in the method development and assay life cycle field. The concepts have been around for quite some time, but now with updated and new guidance for analytical life cycle and analytical method development, we’re seeing a more dynamic period emerging in the space. This includes increased expectations for analytical method development and increased accountability for reporting development data.

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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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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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Investments in Innovative Methods: Rapid Sterility Testing

Speed, control and comparable results: these are among the foremost needs of contract development and manufacturing organizations (CDMOs) and our clients when it comes to plasmid DNA that will be used to support cell and gene therapy at a research, clinical and commercial level. As an early adopter of rapid sterility testing, Aldevron delivers on all three.

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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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