Maryland Startup Apsis Healthcare Systems Striving to Simplify Drug Development Where Technology and Biology Meet
University of Maryland alumni, Sathya Janardhanan, founded Apsis Healthcare Systems in 2018 to help biotech and pharma companies of all sizes simplify drug development through process automation and leveraging the power of Big Data.
Janardhanan, a chemical engineer by trade, started his career in the oil industry but was inspired by what he saw as the growing promise of technology applications in biotech. He pivoted to biotech, joining Amplimmune, Inc. in 2015; he then worked for MedImmune as an analytical development scientist, and eventually became an early employee at NextCure, Inc. and served the company as a senior scientist before launching Apsis Healthcare (Apsis), which is located in Gaithersburg, Maryland.
“I started off as a chemical engineer, and where I studied, this was geared towards the petroleum industry and the chemical sector. As an undergraduate student, I was inspired by the innovation happening in the petroleum sector and saw that a lot of this technology could be applied in the biotech industry to improve drug development,” stated Janardhanan.
“Every day there are millions of dollars pumped into R&D, but there is still an untapped need for advanced engineering to solve the ongoing challenges in the biotech industry. It is still a challenge for drugs with potential to see the light of day because companies struggle with the transition from R&D to manufacturing. Many companies still have to either rely on CMOs or build a manufacturing site both of which are expensive, and the shared tech transfer challenges, in either case, are immense,” he added.
While Janardhanan was at NextCure, he leveraged his chemical engineering background and his prior experience in protein chemistry and drug development to help the company build novel automation infrastructure from scratch.
“Most early stage companies that choose to internatize manufacturing infrastructure want to build something that fits their needs as an early stage company and enables them to run a dynamic range of processes that are easy to transfer out to a third party or a future business partner. This novel automation is intended to give early-stage biotechs access to instrumentation and manufacturing equipment that could help them operate like any commercial company but at a fraction of the cost,” stated Janardhanan.
“So I developed novel process hardware that could help carry out process development in a sophisticated manner and then move seamlessly into manufacturing. It was a remarkable experience for me — it struck me that if I could make more advanced technology it could benefit both late stage organizations and early stage companies to make the tech transfer process from development to manufacturing easier and failsafe. I could do this while also introducing leaps in the type of underlying detection that was driving process decision-making,” he added.
This propelled him to launch Apsis.
Apsis is a startup with a small group of experienced engineers and biochemists that understand the remarkable potential that exists when technology and biology intersect. The young, emerging company is developing technology to fill product development gaps by connecting and integrating resources to rectify inefficiencies. Apsis Healthcare is building a suite of hardware and software tools in addition to eventually offering its clients a unique blend of services that will help drug scientists, process engineers and decision makers overcome process challenges.
Apsis will offer its clients a continuum of tools and services that will simplify and streamline transitioning drugs from research benches to clinics around the globe. Apsis’s first offering will be a future-ready automation product focused on the Biotech Chemistry, Manufacturing, and Controls (CMC) space.
“As an industry we run a lot of processes every single day. There is a ton of information that can be collected. So how do you make sure you can harness all this information? Bioprocess Engineers are not generally computer science majors, so how do you give them the tools that they need to better collect data and do better things with it?” questioned Janardhanan.
“This is a hardware and a software problem,” he added.
Apsis is currently developing its own novel Process Analytical Technology (PAT) tools. The concept behind PAT is to help teams leverage the ample information generated by a process to gain a greater understanding of the process itself while empowering engineers to take action in real-time to control the process and mitigate risks. The real challenge, according to Janardhanan, is not generating as much productivity from a single bioreactor or unit operation; rather, the challenge is finding ways to use data captured in real-time to reduce the risks of running a bad batch.
“Early stage companies are always trying to do more with less. Many early stage companies try to move into clinical manufacturing having done only 5 to 10 development runs. They are trying to get a view into their process in a few runs. For later stage companies, they develop a Phase III ready process early on, knowing fully well it might not make it there. The priorities for early and late stage companies are different…But our PAT and software can give early stage companies a better view into their processes; our products are also applicable to later stage companies, empowering them to share knowledge better with their partners,” stated Janardhanan.
“One of the quirks of the biotech industry is that the way we share knowledge is completely rudimentary. We essentially take this complex process and analytical data and we dumb it down into PowerPoint slides, which do no justice to the underlying raw data of these processes. We try to give these companies the ability to collect a large amount of data and share it with their partners for future development. Our cloud data lake is a platform that they can use to share data with their teams to better develop their process and product, ultimately de-risking it,” he added.
“Anyone that has done a business development transaction knows that a company with a very well developed process, and a deep understanding of that process, almost always gains a significantly better valuation than a company that does not. A potential buyer wants to understand how much risk is involved and having a lot of data de-risks the acquisition in a buyer’s mind,” continued Janardhanan.
Apsis is integrating its PAT product with the Cloud, introducing elements of Artificial Intelligence and Machine Learning. The company’s ultimate goal is to integrate its products with its own data process cloud so that companies can use the platform to scale, generate data visualization and build data models. Eventually, Apsis will provide early stage and late stage biotechs a fully integrated suite of enterprise hardware, software and consulting service products.
The company is currently working on securing biopharma partnerships for the use of its Process Chemistry detection and collection, called Curie, which uses spectroscopy and other process chemistry detection. At the same time, the company is striving to gain traction in the industry with its process data cloud, a Software as a Service (SAAS) product, that sits on top of existing manufacturing systems. They hope to make mathematical model development, deployment and use a simple exercise for bioprocess engineers in small and large companies.
“We’re really doubling-down on product development right now. Our hope is that later this year companies will have that pent up demand for new innovation and technology development.
By the end of 2020 and into 2021, we hope to see greater adoption of our PAT hardware and we expect to release the first version of our process data cloud in early 2021. Our goal is to see both of these products take on a life of their own by the end of 2021, where we see companies use our PAT process data collection hardware and maximize its use via our process data cloud. By staying focused we can really apply our immersive development model with our partners,” stated Janardhanan.
“Customer adoption is the best currency you have when you decide to go for venture capital. You can let your customers tell your story. We’re a fully bootstrapped company. We are very focused on gaining customer adoption and making sure our customers are comfortable with our PAT and process data cloud. Once we can show a few quarters of growth, we’re confident that will paint the picture that VCs want to see,” he added.
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