23 Questions with Harrison on
Analytical Development
23 Questions with Forge is our fast-paced series where our team members are challenged to answer 23 rapid-fire questions about trending topics in gene therapy development.
Harrison Dalby, Senior Associate Scientist in Analytical Development, takes us on a deep dive into the critical role of robust analytics in gene therapy manufacturing. Plus, he shows us a cool automation robot, and sets the record straight about his water polo championship.
Read the interview:
Hi! Can we interrupt you for a quick interview? It’s just 23 questions…
Harrison: Hello! No problem.
Tell us who you are, and what do you do at Forge?
Harrison: Sure. I’m Harrison Dalby and I am a scientist on the Analytical Development team at Forge.
What is the role of Analytical Development in an end-to-end CDMO like Forge?
Harrison: We work on developing tests (or assays in industry terms) so our clients can show regulatory bodies that their drug product is what we say it is, and that it is safe and potent.
What kind of samples do you test?
Harrison: In process, drug substance, and drug product samples from AAV batches are tested. We also test all plasmid and cell banks.
I've heard a lot about potency. Why is this so critical?
Harrison: Yes, potency is a highly critical assay. It’s an important assay to show functionality of the vector.
OK, time for a fun ice-breaker. Looks like you’ve been hiking! Where was that photo taken?
Harrison: Yes, my wife and I love to hike! We just got back from Portugal. That was Cabo da Roca.
Lately there’s a large focus on automation everywhere. Is Forge doing any automation in the AD process?
Harrison: We’re always looking to stay at the forefront of new technologies, including AI, and yes, automation.
In fact, I can show you a really cool robot…
Marina: I’m in!
Wow, I feel like we’ve been transported into the future! What does this do?
Harrison: It is an automated liquid handler. Basically, it can carry out tests that would normally be done by a scientist on the benchtop by hand.
Oohh…the robots are taking our jobs, aren’t they?
Harrison: Well, someone has to press the button, so my job is safe! In reality, robots are a great addition to our process. By automating these assays, we free up scientists for other critical tasks and decrease the chance of human error.
Personal question. I hear you’re a water polo champ? Tell us more.
Harrison: Ha! Not exactly…it was INNER tube water polo. I was on the OSU intramural team and we were champs two years in a row. Not many people know about the sport, but it’s exactly as it sounds!
Neat! So being that you’re in AD, what’s your favorite assay?
Harrison: Mass spectrometry!
How long does an assay take to develop?
Harrison: This depends on the analytic being pursued. One example is AUC could take up to a month of wet work.
What’s the next step then?
Harrison: Working with our Quality teams to perform assay qualification.
What is assay qualification?
Harrison: Running a strict study to show that the assay we developed is performing as it should consistently.
Then the assay is complete?
Harrison: No, now we have Validation! Hold on for a second please. This is set for a while, so let’s head out to Main Street and we can keep chatting.
Marina: Let’s go!
So, tell us more about how your team interacts with clients along their manufacturing journey?
Harrison: We are their partners every step of the way.
How do clients benefit from this partnership?
Harrison: It’s a joint effort and our shared goal is delivering safe and effective products to patients. They rely on Forge to ensure timely communications on progress during the AD process and we rely on them for SME input and approvals.
What’s the last big assay you worked on?
Harrison: DDPCR
Oh wow, that’s great! Well…actually…what’s DDPCR?
Harrison: Haha! DDPCR stands for Droplet Digital Polymerase Chain Reaction and it is an assay to quantify the amount of therapeutic product during different parts of process. This assay allows us to monitor the process, and evaluate if we are reaching the clients’ expectations.
Time for another fun question! I’ve seen Forge employees wearing these pins and been wondering what do they mean?
Harrison: It’s the blue flame pin. The color means I’ve been at Forge 4 years. I was here close to the very beginning when we were just a fledgling startup and it looked like that.
Wow...so much has changed! What differentiates Forge in the AAV manufacturing space from an AD perspective?
Harrison: Our platform assays are really geared to helping gene therapy developers from early stage to GMP, and can speed timelines by several months.
Is it true that your assays are all performed in-house?
Harrison: There are certain assays we wouldn’t want in our facility such as in vitro adventitious agents which are outsourced for safety. But Forge has an impressive list of in-house assays.
Last question. Is there anything else you want to share about working at Forge?
Harrison: I joined Forge because I wanted to make a difference I know that each test we perform has the potential to impact a life.
Marina: That’s great…I love to hear the motivation for what people do.
Harrison: Well, I have to go run a SECMAL (that’s a Size Exclusion Multi Angle Light Scattering). Want to come see?
I think I’m OK…you lost me at Light Scattering. You’ve already answered 23 questions. Thanks Harrison!
Harrison: Sure. When you’re ready to see a SECMAL look me up!