CRISPR Electroporation of T Cells Improves Treatment in Patients with Refractory Cancer

MaxCyte Puts A Focus On: Winston Harvey, MSA, MHA, Manager, Clean Room Manufacturing

Winston Harvey, who has worked at MaxCyte for almost two years, is a management professional experienced in organizational planning and development, team building, mentoring and leadership, as well as lean and GMP manufacturing. He excels at facilitating change in a workforce to support re-engineering initiatives and meeting organizational operating, financial and quality objectives.

What drew you to MaxCyte?

Someone at MaxCyte contacted me and shared that they were moving into a new facility with expanded in-house manufacturing capabilities. Having never heard of MaxCyte, I began looking into the company and was intrigued and impressed by its science, products and how all of it came together to benefit people. I called them and Karen from HR explained to me that they would soon be manufacturing ExPERT™ processing assemblies (PAs) for GMP and clinical research applications in-house in a new facility. Her energy and excitement about the company was contagious so I applied and got the job. When I started, I had one person on my team. Fast forward almost two years later and now I have nine people.

What do you enjoy most about working here? About your team?

There are several things I enjoy about working at MaxCyte – the diversity of the people, their kindness – everyone is personable and down to earth. The company is amazing, and I’ve never worked anywhere like this, especially one that treats hourly employees so well. They treat everybody equitably. Our CEO takes the time to come around and talk with people – he knows all my employees by name, which is impressive.

My team members are very conscientious and love their jobs. They are on the front line, building PAs with care in a clean environment to ensure that we are sending out high-quality products. They recognize that the reputation of the company depends on us. I really appreciate my team and everything they do – they’re awesome!

Why is the work you do critical to the company’s mission (to pursue cell engineering excellence to maximize the potential of cells to improve patients’ lives)?

I have made sure that my team understands that the PAs we are manufacturing are used to literally save people’s lives. The ExPERT™ GMP PAs provide the scale and quality standards required for our partner’s clinical research that may turn into treatments and cures that will transform human health. Therefore, everything we do in the GMP clean room is done with intent.

When we move within the room, we don’t pace back and forth so as to not stir up particles. If we are working at the bench, we don’t jump up and quickly walk across the room. Unless you are working in a level one clean room, particles still exist in every environment. We make sure that we’re intentional in our movements and how we behave so as to not impact the quality of our PAs.

They’re trained in how to properly clean the clean room, and maintain that cleanliness, even before entering the room. We test for particles every single day and do bio lock viable testing with the plates.

We are also focused on organizing and labeling – success is all about ‘everything has a place, and everything is in its place.’ We’ve actually developed a system where everything is categorized. For example, we have all of our PPE on shelves with the product number, name, amount on hand, and reorder rate and quantity. I’ve assigned different assemblers to specific areas and all of my team have had some level of success training, which is part of the lean process.

Mistakes in manufacturing of other products may just be an irritant for some people, but for our products, it could impact somebody’s health or life. Our work is vital to this company and to the viability of people.

What is your team’s biggest priority for serving MaxCyte’s partners and how does it fit into the Company’s strategic growth plans?

A year ago, we moved into our new facility that contained a 1,400 square foot, state-of-the-art, ISO-7 clean room, that we had validated, bringing manufacturing in-house from our third-party manufacturing vendors. We started with two assemblers and two types of PAs and today, my team of nine has the capability to build many more products in much larger quantities to support the growth of our partners and customers.

As we continue to bring more manufacturing in-house, our biggest priority is validation and adoption runs. We recently added automation with our electrobus (EB) applicator, which applies the film used to perform the electroporation. We’ve also brought in an ultrasound welder. Currently, our EBs are pressed by hand, but we now have a machine that will place them in the carousel until they are ultrasonically welded together. With these types of automation, we will be able to significantly increase our throughput.

As the company continues to invest in expanding its capabilities to support its partners’ commercial efforts, we’ve made sure that we have the capacity to meet their needs during this transition to the new clean room. We’ve retained our third-party manufacturer to mitigate any risk of not being able to build enough of the necessary PAs; we’ve been able to keep plenty of product on the shelf and have never had a back order, even during the pandemic.

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