Aldevron Breakthrough Blog: Clinical Grade Manufacturing/cGMP

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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Combining Resources to Streamline and Standardize Therapies

Academics and manufacturing making processes better

Witnessing firsthand the growth of cell and gene therapy to progress more programs to the bedside is an exciting time in the biotechnology industry, particularly with new partnership approaches being developed. I was able to get an overview of one particular partnership during a podcast featuring Tom Foti, VP of Protein Business unit at Aldevron, and Kris Saha, Ph.D., Associate Professor of Biomedical Engineering, Medical History and Bioethics at the University of Wisconsin.

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Four Major Steps Involved in mRNA Manufacturing

From potential to solution

For more than two decades, in vitro transcribed (IVT) messenger RNA (mRNA) has been considered for its potential to address unmet medical needs and to transform the development and manufacture of medicines. This potential was suddenly realized by the unprecedented response to Covid 19, ushering in a new era in the application of mRNA technologies to solve challenging health problems.

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Unspoken Themes

Big topics not always on conference agendas

For events such as Biotech Week Boston, industry leaders, suppliers, regulatory agencies and academia come together to collaborate, present and partner on topics related to biotechnology, specifically therapeutics. And every year there is an unspoken theme you don’t see on the agenda, where speakers, attendees and sponsors discuss shared pain points, challenges and what the future could hold. 

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How Did My Project Get So Expensive?

The Hidden Costs of Multiple Tech Transfers

Move fast. Limited funds. Novel ideas. These are consistent themes I’ve noticed in conversations with hundreds of biotechs over the last 20 years, and rightly so. However, these elements sometimes overshadow the need to evaluate the complexities and costs associated with GMP manufacturing in support of a clinical trial, along with what’s needed for manufacturing at phase III and beyond.

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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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