STEM Pros:

Ashley Craddick, Senior Director of GMP Manufacturing

Senior Director, GMP (Good Manufacturing Practices) Manufacturing

Forge Biologics

Please provide a summary of your job or research. What is an average day like?  What are some duties performed?

I am responsible for manufacturing clinical and commercial Adeno-Associated Vector (AAV) that are used for the treatment of rare genetic diseases. AAV are viruses that can be used to deliver DNA to target cells. They are the most common viral vectors used in gene therapies because they can enter different types of cells, don’t cause viral illness in humans, and usually don’t trigger an immune response. AAVs are also useful in neuroscience research.  I specialize in the downstream purification and fill processes. My average day is ensuring the manufacturing team is set up for success to execute on client productions. I am involved in a lot of strategic thinking and planning for my group and the entire organization. I interface with the clients often to ensure we are delivering the product with the highest integrity and proper amount for their patients and/or clinical trials.

What is your educational background and what prompted you to go this direction?

I have a Bachelor’s Degree in Chemistry and Biology. I have a certificate in Executive Leadership and am pursuing my MBA. My original career plan was Dental School, I shifted gears after my undergrad when I only got into school across the country and my grandmother was ill. I got into Gene Therapy right away and haven’t looked back. It’s an amazing field and I couldn’t imagine not being in it.

What have you struggled with or overcome in your educational path or life path to get to this point?

I grew up on the west-side of Youngstown, OH which is an area that has struggled economically and with high crime rates. I never needed anything growing up, but we also got through things with what we had. I attribute my hard worth ethic and sense of pride to my upbringings and where I am from. I was the first in my family to graduate college.

What is the best part of your job/research?

The best part of my job is the science! We bring ideas to life and provide access at scale to medicines that give hope to patients that have no other options. Working in the rare disease space is a very unique opportunity that also gives the work we do a purpose to service the people and families affected by their condition.

What is the worst part of your job?

The worst part is getting things wrong. It’s not uncommon to have failures in science and we learn so much from that, but it’s tough to manage through especially when there are patients waiting for their treatments.

What’s the most exciting part of your job?

The most exciting part is seeing all the amazing programs come through our manufacturing facility. It’s amazing to see all the different indications that gene therapy can help!

What has changed about your profession in the past ten years?

In the past 10 years there has been a significant paradigm shift to focus on platform production processes that target HEK293, or Human Embroyonic Kidney Cell 293. This cell 293 is commonly used to make AAVs. There is a lot of focus now on using this cell in suspension-based bioreactor manufacturing. A bioreactor is a single use container in which raw materials and living cells, such as the plasmids and HEK293, are put together to create desired products. There is also a new focus on more structured downstream purification techniques which occur after the bioreactor stage to make the AAV ready for injection. There has been a lot of development on the design of the vector that deliver genes to patients, as well to ensuring the safety and quality of the therapeutics.

What do you think will change in the next ten?

I think automation and Artificial Intelligence/Machine Learning will become prevalent over the next 10 years. This will change the way vector constructs are designed and selected. I think we will see an increase of process automation too beginning with filling product into vials and making its way throughout the entire process. I can see gene therapy reaching oncology and non-rare disease spaces to treat even more patients as we continue to advance the technology for scaling up!