23 Questions with Ron & Mark on Forge's Facility Dedicated to AAV Manufacturing

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.

In our latest episode, we go inside the Hearth with Ron Chantung, Senior Vice President of Operations, and Mark Galinato, Senior Manager of Plant Engineering and Reliability, to showcase the infrastructure at Forge’s purpose-built facility for AAV manufacturing. From the flywheel that powers uninterrupted manufacturing to dedicated air handling systems and a walkable ceiling above our cGMP suites, Ron and Mark share how operational excellence and commercial readiness have been planned for and built into every layer of Forge, from day one. Watch the full video below!

Read the interview:

Hi! Can we interrupt you for a quick interview? It’s just 23 questions…
Ron: Talofa! Of course you can. Ask away.

Talofa to you! More on that in a jiffy. First, tell us who you are, and what is your role here?
Ron: My name is Ron Chantung, and I am the Senior Vice President of Operations here at Forge.

That’s a big title. What exactly does it encompass?
Ron: It is. And I’m really lucky that I have some of the best people I have ever met in my career to work with at Forge. They include MSAT, Manufacturing, Supply Chain, Planning, Project Management, Facilities and Engineering, and Site Services and collectively, we’re responsible for executing AAV manufacturing runs.

So, you’ve been at Forge for a year, and you were previously with Ajinomoto?
Ron: Yes. I was fortunate to work at one of Aji Bio-Pharma’s businesses where I gained valuable experience in drug substance and drug product manufacturing. Getting the opportunity to work here has been the privilege of a lifetime.

Forge is one of the largest CDMOs dedicated to AAV in the world. How are you leading capacity growth while maintaining strict adherence to cGMP standards?
Ron: Our commitment to Operational Excellence (or Op Ex as we say) as a high-growth CDMO is two-fold…one is to improve employee and client satisfaction through optimizing processes, and two is creating sustainable, controllable reliability with our commitments to clients and patients.

OK, we usually start off with a fun ice-breaker to get to know you better. I heard that you are a Pacific Islander and you are a surfer! Any lessons from the ocean that inform how you lead high-stakes manufacturing?
Ron: Yes, I was born and raised in southern California. My parents were immigrants to California in the late 60s from Western Samoa. I spent a lot of time at the beach in Orange County. The ocean is constantly changing and dynamic based on factors like weather, tide, wind, time of day. Over the years I’ve learned that dedication, practice, displaying a sense of calm, and the right equipment or boards make or break a surf session. Applying those principles like self-motivation, a positive attitude, accountability to work and the staff is my personal commitment to Forge. Knowing that the Hearth was purpose-built by like-minded leaders and a top-notch facility is the foundation we rely on to make life changing gene therapy drugs.

That makes me want to see some of this facility for myself. Can you show me around?
Ron: I have a better idea. I’m going to send you to someone who can show you some really cool aspects of the Hearth. Ask for Mark…he’s great.

See you later then!

Are you Mark?
Mark: Now I can hear you better! Ron asked me to show you some critical utilities in our facility.

First, what do you do here at Forge?
Mark: I am Senior Manager of Plant Engineering and Reliability, and I’m a leader within our facilities and engineering team. We are responsible for the support of overall facility and equipment performance, reliability, and regulatory compliance for both cGMP and non-cGMP operations.

What is that you were looking at?
Mark: The flywheel, Uninterruptible Power Supply (or UPS) is one of two backup power systems in our facility and operates in coordination with on-site generators. During power events such as sags, dips, or outages, the flywheel delivers stored kinetic energy to provide immediate, short-duration power, bridging the gap until the generators assume the full electrical load.

So how much power exactly does that flywheel provide?
Mark: 3.2 megawatts, which is equivalent to powering 32,000 homes in an hour!

Wow! How does this impact the clients we serve and their patients?
Mark: Ultimately, the flywheel supports continuous manufacturing, ensuring patients get the medicines they need.

What can you tell me about capacity expansion?
Mark: As we speak, our cross-functional subject matter experts are conducting comprehensive utility assessments to continue to meet any client needs as they prepare for commercialization. For example, we are updating life-cycle documentation and critical equipment to support commercial readiness.

Interesting! Mark, you get a fun question. I hear you and Ron see each other on the golf course often too. Is that right?
Mark: Yes, golfing is one of my passions. Ron and I love to hit the driving range together to work on his short game.

Haha! Can you tell us what Op Ex (as I hear you call it) looks like for you on a daily basis?
Mark: Yes, Operational Excellence inspires every one of our daily actions, from the moment we turn the lights on to how we troubleshoot any issues to every step of the manufacturing process.

I want to get back to commercial readiness…can you say more about that?
Mark: We’ve been deliberately building toward commercial manufacturing from day one. These are our air handlers here, for example. We installed them years ago with that intent. Our air handlers provide the cGMP suites with proper ventilation, humidity, and pressure. It is also equipped with UV lights inside that also provide an additional layer of protection and keep the handler clean.

That was great foresight. Do these ducts feed into the entire building?
Mark: Our air handler is dedicated to supplying clean, controlled air to our cGMP suites, where strict regulatory standards differ greatly from normal office or lab spaces. This specialized system ensures that all cleanrooms maintain cGMP-compliant air quality.

Wow! Can you show us where these lead?
Mark: Actually, I’ll send you back to Ron. He’s doing a duct inspection above our suites right now.

Perfect! Thanks Mark.

I feel like I’m on a movie set! Where are we?
Ron: Yup! We’ve recreated the HVAC duct where Bruce Willis as John McClane says, “Come out to the coast, we’ll get together, have a few laughs…”

Is that a line from Die Hard?
Ron: You know your movies!

And is this a common sight at other manufacturing facilities?
Ron: No, this is not typical! It was an intentional decision to have a walkable ceiling above our cGMP suites. It offers a safe accessible platform for maintenance without interrupting activities in the suites. It also optimizes efficiency by reducing downtime and increases suite footprint by utilizing the vertical space.

So, Forge has been part of Ajinomoto for a while now. How have things on the ground changed?
Ron: Over the years the Aji Bio Pharma umbrella expanded to include small molecule, oligonucleotide, ADCs, large molecule, and through Forge, gene therapy manufacturing. It’s been exciting to observe and participate in the scope, growth, synergies between our partner sites, and especially their legacy in operational excellence integrating our commitment to ASV.

I’ve heard about ASV. Can you tell me more about it?
Ron: ASV stands for “Ajinomoto Shared Values.” It is our business approach to solving challenges while creating social and economic impact. Forge is a proud contributor to ASV by producing life-changing gene therapies for patients with genetic diseases.

Ah! There’s so much more I want to ask you, but that’s 23 questions! We’ll need a sequel soon…
Ron: That sounds like a plan. Die Hard with a Vengeance. I’m in!

Thanks Ron (and Mark!) for that incredible look at the inner workings of this facility.