Issue:May 2018

EXECUTIVE INTERVIEW - Singota Solutions: Keeping Up With Trends & Technology as a CDMO

Each day at Singota Solutions, their team of experts focuses on getting products to patients faster by being an agile, accountable, and transparent CDMO. So, what sets Singota apart? Responsiveness and dedication to getting things done quickly are what they say their clients value. Singota collaborates closely with their clients, customizing services to support products moving through the development process. It is not always easy being a smaller CDMO, but clients that fit into their niche end up staying. Drug Development & Delivery recently interviewed Brent Lieffers, Senior Director of Operations, to discuss the need for keeping up with trends and technology as a CDMO.

Q: What does the typical Singota client look like?

A: Our clients range from small virtual firms with no internal testing or manufacturing capabilities whatsoever to some of the largest pharma companies in the world. Obviously, the needs across the spectrum of our clients are wide-ranging, which is fine, because we take an individual approach to each client we serve. We try to keep in mind that each of our clients, while unique, are all working toward an important goal – helping patients. And without exception, they want their project done on time, so we must be smart and judicious with our time to meet their needs.

Q: As a CDMO, you do not have any of your own products. Do you find it difficult to connect the dots from your service to the end users – patients?

A: Our company was founded with the goal of getting needed therapies to patients faster. We take that goal seriously, and actively foster a patient-centric culture. For example, we recently screened a movie for all our employees over a couple of lunch hours. The film was written and produced by a patient suffering from a disease for which one of our clients is pursuing a new and better treatment. We also seek out opportunities to meet patients who have directly benefited from work we have done for our clients. Those types of interactions keep our passion for helping patients alive and strong.

Q: Technology is advancing quickly in your industry. For instance, I noticed Singota is using a gloveless, robotic isolator workcell for aseptic filling. What prompted Singota to select this technology?

A: The innovative technology that allowed Singota to recently add aseptic filling to our CDMO capabilities was not even available just a few years ago. The speed with which technology advances continues to amaze me. However, it’s no secret that our industry has been slower than other sectors in adopting and embracing some of the newer technologies. Thankfully, I believe we are seeing more progress now, and I’m very encouraged with the support we have seen from the regulatory agencies and especially some of their focus groups, such as the Emerging Technology Team at FDA.

We decided to add the aseptic filling workcell to expand our services and offer a technology to our clients that would be flexible for different component types and help accelerate production times while providing the product quality they expect – if not better. The increase in availability of Ready to Use (RTU) containers, closures, components, and consumables was integral to our design and planning and allowed us to go from idea to User Requirements Specification (URS) to build/install to validation with very short and aggressive timing. And that again fits the company philosophy, to help our clients shorten their timelines and get products to patients in the clinic faster.

Q: Is it difficult to maintain and meet quality standards when trying to move quickly? How does a CDMO achieve that?

A: Quality always comes first. It might sound a bit cliché, but ensuring quality is everyone’s job, and at Singota, it’s our culture. There are some things that take time and can’t be avoided – equipment qualifications, personnel training, writing and reviewing copious amounts of documentation, etc. We work hard to do things right the first time, and in the long run, that saves time. We also work within our capabilities, being careful to not over promise…making sure we can do what is needed.

We can control our internal processes and also seek out suppliers who hold the same values for quality. We greatly value the work our key suppliers do for us. When we enter into a relationship with a supplier, we look at it as a collaborative partnership versus a traditional vendor/buyer association. We have developed some wonderful supplier relationships that allow us to work together closely to find the best ways to meet our clients’ unique needs while never compromising our quality standards.

Q: What are some industry trends you are seeing?

A: The trend toward smaller is well underway. The promise of personalized medicine has been around for a long time, but it is more than just a promise today. I believe the era of blockbuster drugs and massive manufacturing operations to generate millions of doses is transitioning to one of smaller patient populations and, by necessity, smaller and more flexible manufacturing processes. There will still be a need for some of those high-volume drugs, but that is not where Singota is looking to make a difference. Rather, we focus on high-value drug products that serve smaller patient populations and fit into our smaller manufacturing model.

Another industry trend we’ve noticed is the acceptance of robotics in pharmaceutical manufacturing. Automation and robotics are firmly established in most manufacturing sectors. And look at how far along autonomous vehicles have come in the past year or so. We can finally see this technology having an effect on our industry. Isolator technology has allowed us to remove the impact of operators from the initial aseptic environment, and robotics are now allowing us to remove operator variability from the process as well.

Q: Because flexibility is essential for smaller operations, how does Singota intend to address scale-up issues?

A: I recently heard the term “scale-out” used, as opposed to “scale-up,” and that is exactly how we are approaching our parenteral manufacturing. By adopting a platform approach, we can add capacity by directly duplicating current unit operations, not starting over creating larger versions of our processes. This allows a more seamless capacity expansion and avoids unnecessary downtime during the transition. Singota is a single-site company, but you can easily see how this philosophy is very attractive for multi-site manufacturers as well.

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