Aldevron Breakthrough Blog: Research Grade Manufacturing

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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Suppliers – You Can’t Live Without Them!

Great relationships and open, honest communication with suppliers can reduce daily pain

These are unprecedented times with challenges we have never seen before. Maintaining a continuous supply of raw materials has become increasingly difficult since the start of the pandemic and with the on-going geopolitical uncertainty. The recent rise in oil prices is also increasing stress on everyone’s supply chains.

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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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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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Top things to consider when returning to the lab in the era of COVID-19

The work you perform is essential, and returning to the lab during the COVID-19 era poses several challenges. When you work with a safety-first mindset during your workday and follow the lab and local government regulatory guidelines, you may continue to carry out your essential duties while posing little risk to yourself and those around you. Here are some tips on how to smoothly transition back to work in the lab.

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What to Consider When Using DIY Kits for Plasmid DNA Production

Plasmid DNA purification has come a long way since Herbert Boyer and Stanley N. Cohen's experiments in the early 1970s. Molecular biology is now dominated by the various ways recombinant DNA and RNA can be manipulated, and purification techniques have evolved to meet this demand. In sharp contrast to the complicated, labor-intensive efforts that were needed in previous decades to extract even a small amount of DNA, there are now numerous easy-to-use DIY kits available that enable researchers to obtain the DNA they need.

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Using Quick Response Manufacturing (QRM) to Reduce Turnaround Times

"Biomanufacturing" and "efficiency" are two terms that are not commonly seen together, but researchers at the University of Wisconsin-Madison Engineering Department along with protein manufacturing experts here at Aldevron are taking big steps to change that.

The application of Quick Response Manufacturing (QRM) theory to biological processes is a unique initiative whose goal of reducing lead times for manufacturing operations is the core focus of the UW and Aldevron partnership. 

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