Every year, an estimated 300,000 children are born globally with a severe form of sickle cell disease. This is a genetic disease that causes red blood cells to be a sickle shape, leading to episodes of pain and anaemia, along with the potential of stroke or kidney damage.
CRISPR genome editing has enormous potential as a means to treat genetic disorders, such as sickle cell disease. However, despite massive success in pre-clinical experiments, the impact of CRISPR in the clinic has been relatively limited.
One problem is a lack of options for large-scale delivery of CRISPR enzymes to patients.
Earlier this month, Aldevron and Synthego co-sponsored a GEN webinar exploring excitingnew research into how to deliver genome editing enzymes in vivo into patient cells.
The team at Aldevron is excited to virtually celebrate our recent expansion in Madison and share the great progress we’re making and opportunities ahead in the world of gene therapy.
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!
This was a significant month for our industry, and for the world. Vaccine development has been around in some form for centuries, but this month revealed groundbreaking transformations in controlling a global pandemic.
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.
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.
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.
Aldevron has taken the basic design of heating, ventilation, and air conditioning systems (HVAC) for biological manufacturing clean rooms a step beyond the industry standard. The result is a super-clean system in our primary facility that allows us to produce the highest quality plasmid DNA, proteins and enzymes. In fact, from a cleanliness standpoint the Aldevron HVAC system is the cleanest I’ve worked on in my 20 years in the industry.