Accelerating ATMPs Speed to Market Through Flexible and Future-Proofed Manufacturing Capacity Solutions

In this interview, Pete Makowenskyj shares insight into how G-CON Manufacturing is providing flexible manufacturing opportunities to meet the growing ATMP manufacturing demand, through sustainable, ‘future-proofed’ solutions.

Could you please introduce yourself and explain a little about what G-CON is involved in?

My name is Pete Makowenskyj, I’m the Director of Design Consulting at G-CON Manufacturing. Our team is responsible for the engagement of our clients and understanding process requirements to ensure that we can put together a suitable solution based on our prefabricated cleanroom technologies.

G-CON was founded in 2009, so we are a relatively young company. Our technology was born through the need of the autologous cell therapy space. We were founding our sister company at the time, which was in the autologous cell therapy space, and they needed to expand their manufacturing capacity. They constantly had to shut down their site, which meant that they couldn’t stockpile their drugs, so they couldn’t treat patients during the time where the facility was shut down. That gave rise to G-CON. At the time there were no pre-fabricated autologous cleanroom solutions on the market. The goal of our technology was to help facilitate the ability to expand capacity without interrupting existing manufacturing space.

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How can we overcome key issues associated with ATMPs speed to market?

In this space, specifically the ATMP space, a lot of our clients’ primary drivers right now is speed to market. They’re looking to get their therapies out there as fast as possible because these are lifesaving therapies that are often meeting an unmet need in our patient populations. Getting this capacity up and running fast to ensure that the clinical trials can be conducted as fast as possible, or to get commercial operations up and running without any downtime, are some of the things that our clients are really keen on right now.

I think this was really exemplified in the recent Covid-19 crisis. Before, there was no capacity to build out all of these vaccines and support a global population. Getting these facilities up and running in as short an amount of time as possible was really one of the main drivers to get us past this pandemic as soon as possible. Obviously, that hasn’t happened as many would have thought it would have, back when these vaccines were originally introduced, but the important thing is they’re saving lives. The ability to get the capacity up and running sooner was just saving that many more lives as fast as possible.

How did the pandemic affect capacity availability and speed to market?

Initially what we saw with Covid-19 was a lot of mandated shutdowns, so there were some intrinsic delays when clients weren’t able to work on site. The good thing with our solutions is that we were given a certain designation so that we didn’t need to shut down, because we were in the space where our technology was deemed critical for infrastructure that needed to be supported in that interim and in the environment surrounding Covid-19. We had to ensure that we had proper social distancing and that proper procedures were in place.

Our technology allowed us to operate as a center of excellence. We prefabricate everything off-site and can control the conditions in which we operate – in this field you don’t often have that luxury. We were able to help support our clients by manufacturing off-site so that we weren’t crowding their site and they were able to have their onsite trades do their thing, while we were supporting this critical piece of infrastructure at our site. In this way our technology was well suited to operate in the Covid-19 environment. I think a lot of our clients appreciated that and it took a lot of pressure off the onsite demands that they were facing.

How can flexibility aid the development process for ATMPs?

Our technology is very flexible in nature. We are able to support clients who aren’t necessarily sure what their process may look like. Many times we are actually designing the clean room facilities as our clients are still developing that process. This is still a relatively young or immature space compared to other segments in the biotech space, so that is something that we need to accommodate for, for a lot of our clients, and ensure that we can still meet their facility needs, but concurrently design along with them.

Building a manufacturing site off-site is one luxury that we do have – our technology is also mobile. When we talk about looking at ways that infrastructure may not be appropriate in the future, this solves that problem. You can move these PODs and either redistribute the manufacturing network to another location within the client’s manufacturing network or repurpose them for a completely different need. This is something that you can easily do, unlike a typical fixed installed facility.

What else contributes to enabling flexibility and stable development for ATMP developers?

Our goal is always to help guide our clients as much as possible by showing them what we’ve done that has worked in the past.

We have developed an assortment of catalogs, most recently we launched our viral vector catalog. The goal there is to provide a starting base to look at and understand what works and what would work for them. We’re not necessarily reinventing the wheel every time as it’s not necessarily needed in this space. As long as the client provides a flexible design space within our facilities, having them see how it’s been done in the past and how they can leverage that kind of GMP compliant facility layout, they’ll just tweak things here or there to suit their specific needs. They’re not necessarily starting off with a blank sheet of paper, and that’s really very helpful for a lot of our clients.

A lot of them are also in a space where they don’t have an existing manufacturing network. A lot of these companies in the ATMP space are doing manufacturing for the first time. They’re going from a virtual model where they’re reliant on studios to take manufacturing in-house. That also alleviates some of the constraints that we may see where they don’t have a historic team that’s done this day in, day out for them.

What advice would you give to someone developing ATMPs and exploring their manufacturing workflows?

One of the things that that they don’t need to do today, is over-expand capacity. There have been a lot of lessons learned where too much infrastructure went up too early and the anticipated market demand didn’t align with the actual future capacity requirements. Now you’re able to design a facility and build it out incrementally, which has allowed our clients to more effectively utilize their capital and prioritize where the funds needs to be, as opposed to having a huge capital expenditure on a new facility. Being smart about how you design and build out your facility and incrementally expand capacity is a luxury that wasn’t always there in the past.

How are manufacturing workflows designed with future capacity demands in mind?

We do like to understand what the future capacity needs would be for any client. Through that lens, we would help them develop a model that allows them to easily expand their capacity, and not necessarily have to shut down their manufacturing space. So that’s one thing that we want to make sure that we can properly understand and assess early on in a project, to ensure that that they have that need met.

The other thing is, especially in the autologous space, allowing clients the flexibility to redistribute their manufacturing network. There were a lot of talks five or so years ago about distributed manufacturing. It is becoming something more prevalent today and we’re seeing that the higher levels of automation in this space, from the process equipment side, lessens the demand on operator experience to run these facilities, so that the equipment itself is helping to support the process rather than being reliant just on people. This is giving rise to more people considering a decentralized manufacturing space as you can actually do this closer to the patient itself.

What considerations are made in order to future-proof these solutions?

I think a lot of what it comes down to now, when future proofing these facilities, is to ensure that you don’t have waste. You don’t want to have facilities that are mothballed, you want to have facilities that can handle different types of processes, that you can’t always encounter today, and that that gives our clients a lot of flexibility to operate a facility that they know will work not just for the next five years, but for the next ten, twenty, thirty years. That wasn’t always the case when you had a lot of purpose built facilities with a lot of stainless steel coupled with single use technologies. The facilities today go hand in hand with a high level of flexibility and that gives rise to a more sustainable type of facility, that’s longer lasting.

This interview was produced in partnership with G-CON Manufacturing.

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