Redefining cell line development
Emma Pickup, Sciad Communications, interviews Dr Ian Taylor, Chief Business Officer, Solentim
Solentim is redefining the cell line development workflow. Completion of its new ecosystem offers an unrivalled solution for the enhancement of cell line development workflows and is designed with medicines’ regulators such as the FDA and EMEA in mind. Following the launch of Solentim’s new ICON™ instrument and dedicated STUDIUS™ software, the two of which complete the company’s cutting-edge ecosystem, we spoke with Dr Ian Taylor, Chief Business Officer, Solentim, to find out what this means for cell line development and the future of antibody therapeutics.
The new ICON instrument is tailored to improve cell line development for monoclonal antibody production. Can you tell us why antibody therapeutics are such an important area for Solentim to be focusing on at the moment?
Antibody therapeutics is an area of huge and accelerating development around the world. Treatments using monoclonal antibodies (mAbs) to fight infection or disease are highly specific, have fewer adverse side-effects and are often more effective than traditional therapeutics. Typically based on IgG and secreted by CHO cells, many commercial mAbs are already manufactured at very large scale. The current size of the global next generation antibody therapeutics market is worth USD 3.83 billion and is expected to grow at CAGR of 13% to reach USD 7.06 billion by 2025.
Additionally, mAbs have been shown to be part of an important combination therapy alongside some of the new COVID-19 vaccines, which can only further increase utility and demand.
However, for antibody therapeutics to be viable commercial products, they must be manufactured at scale. For this to be possible, the cells which produce them have high, stable inherent productivity and derive from Master Cell Banks which meet the regulatory standards of the medicines’ agencies.
Solentim has been working on optimizing the cell line development workflow for over 10 years. Can you describe how the Company reached the point of launching its new complete ecosystem solution?
This is a fundamental step-change, a new era for Solentim and for cell line development.
The launch of our cutting-edge, optimized cell line development ecosystem represents a pinnacle on our company’s journey. Historically, we have moved along the CLD workflow and developed new, incremental improvements. However, from this point, Solentim can elevate its customers beyond simply buying discrete instruments and more towards investing in a complete solution which facilitates data-driven cell line development workflow (e.g., filtering on best growers, best producers, clonal origin etc.) underpinned by a fully compliant data and clone management software.
At every stage our instruments have been designed with industry regulators in mind. Our new ecosystem helps customers build confidence in their workflow and ensure data integrity to comply with the needs of the regulatory authorities. We are collecting, analyzing and presenting cell data differently, and changing the way regulatory submissions are made.
Solentim has just launched its new ICON and STUDIUS technologies, which together with the VIPS™ and Cell Metric® instruments complete the ecosystem. Can you shed some light on how the ecosystem will reinvent cell line development?
Each of the instruments in our ecosystem generates insightful, high-quality data to aid cell selection. Each instrument has a defined role and collects essential data on each clone’s journey that, when combined and analyzed by our proprietary STUDIUS software, offers a one-stop cell line development solution which allows our customers to select the best and most valuable cell:
- VIPS: offers high efficiency, high viability single cell seeding and documentation of clonality with our double-lock assurance
- Cell Metric & Cell Metric CLD: capture daily whole well imaging of cell growth, visualizing colony growth and enabling high-throughput colony monitoring
- ICON: conducts rapid assays for the three critical quality attributes of titer, cell number and cell viability, to assesses cell productivity and enable characterization of leading candidates.
- STUDIUS: intelligently manages verified information from multiple sources to enable you to filter out and select the top clones.
STUDIUS plays an integral role in our ecosystem. Drawing on data from all three instruments, it generates a HISTORYTREE™, visualizing the life cycle of each clone and its journey, providing all the data required per clone to support regulatory submission. STUDIUS also protects against data corruption, giving regulators confidence in data reports generated by our ecosystem.
Together, these technologies provide high-value, trusted data on the entire history of each individual clone, tracked throughout the complete cell line development process. The ecosystem allows our customers to streamline their workflows and make smarter, data-driven decisions, earlier. The current norm in the lab can still often be disparate pieces of instrumentation using pieces of paper and multiple Excel spreadsheets; this can now be replaced by our integrated ecosystem.
The ICON is the latest instrument to hit the market from Solentim. Can you tell us more about what it does and how it will benefit customer?
ICON is the third, quality data generator in our ecosystem which adds novel productivity insights to identify leading clones at multiple stages: including the cloning plates, the static expansion cultures and the fed-batch stages. It is the world’s first dedicated system for measuring specific productivity of clones in cell line development.
Currently, there are several instruments on the market that conduct either viable cell counting or protein titer alone. None of these instruments measure both parameters and then combine these measures to calculate the crucial industry-wide metric of specific productivity.
With ICON you can assay clones for normalized titer (titer is normalized to cell number) as early as Day 14 to eliminate non-producing clones quickly. This means you can immediately filter on the clones which both grow and produce. At the lab level, this stratification and consolidation of promising candidates accelerates the cell line development workflow and saves on cell cultures resources. At the manufacturing level, high specific productivity is key to the economics of scale-up for manufacturing, bioreactor occupancy and even plant size.
You have mentioned pharma industry regulators several times in our discussion – can you expand on why so much of your innovative technology is designed with them in mind?
It all comes down to the quality of the data that our customers submit to regulators. For an antibody drug to move forward into clinical trials and ultimately licensing, the medicines’ regulators have to be engaged right from the start. For us, it is therefore vital that everything we do is driven by high-quality, uncorrupted, traceable and trusted data; high quality, well managed data also drives intelligent decision making in cell line development.
STUDIUS, our dedicated new software designed for cell line development scientists, meets this need. It is a purpose-built platform that continually audits data to ensure quality and integrity, making sure that the regulatory submissions packages contain the key data with very high confidence.
Each individual clone’s story is completely backed by a ream of high-quality, trusted data, mapping each clone from its inception in the VIPS seeded droplet and all of its subsequent data points through time. This data-driven approach, documenting every stage of the clone’s journey, is going to change the way our customers plan for regulatory approval, and in turn, what the regulators expect from a customer’s IND submission.
How would you summarize this milestone for Solentim?
This revolutionary ecosystem culminates from Solentim’s 10-year history in CLD. From our heritage, the market and our customers look to Solentim for thought leadership and continuous innovation in CLD. This ecosystem is not only a family of connected instruments, but with the STUDIUS over-arching these systems, this is truly a complete cell line development and clone management system for streamlining projects, filtering the top clones, running more projects and shaping the future expectations of the regulators regarding extent and completeness for the history of a Master Cell Bank.