IDBS Blog | 14th March 2022
Capture Exhilarating High-Throughput Capabilities
Parallelized decision making
While you may not find yourself kitesurfing in Barbados, intuitive cell line selection unleashing powerful high throughput capabilities promises to be exhilarating.
You’re familiar with the problem: you need to conduct multiple experiments in parallel and you need a way to quickly make sense of the data to find the best cell lines and develop a manufacturing process. A common refrain from scientists in biotech getting their candidate process ready to support the creation of material for clinical trials: “help me work faster, make it easy. I want to sample 48 bioreactor cultures before breakfast.”
Our biotech customers came to us with a clear request: “enable us to leverage the most cutting-edge high-throughput process development methodologies and accelerate our drug candidate along the critical path to clinical development.” It’s a big ask. But we’re up to the challenge.
Serial or parallel
High-throughput process development (HTPD) is a big step away from serial, firmly planting both feet in parallel working. Doing things in serial means doing them one at a time, s-l-o-w-l-y, one after the other; parallel means that they are all done at the same time, simultaneously.
Much has been written about the benefits of parallel experimentation and the desire to move away from one-at-a-time and single-factor experimentation. Therefore, I will add what I believe cannot be repeated too often: it’s critical to move away from one-at-a-time experimentation; the path to quality-by-design and robust success at manufacturing is paved with parallel lines.
And so, what about high throughput?
High-throughput tools are systems that enable highly parallel experimentation. But can’t highly parallel experimentation be achieved by a more coherent alignment of scientists in the laboratory? Not quite. High-throughput tools promise a much greater throughput than that.
The bioreactor culture process is typically the longest part of the process development cycle. One substantial impediment to a more rapid cycle is the intrinsic growth rates of commonly employed mammalian culture, with two to three weeks as a common bioreactor culture duration.
Miniaturized bioreactor culture systems, such as the Ambr® 250 and Ambr® 15, can allow up to 48 bioreactor cultures to be performed in parallel, per device. Each device can be run by one or two scientists.
Crucially, these HTPD tools generate large datasets of experimental data that are directly relevant to the large-scale manufacturing process. Scale-down models are not from shaken flasks made.
Where do we begin?
Within process development, cell line development scientists had the most frequent and frustrating pain points with high-throughput bioreactor culture. They see high throughput as the means to overcome a common bottleneck in the critical path to manufacturing material for trials: selection of the best cell lines for stable and correct expression of our product molecule.
In the biotech space, working with investment from big pharma and venture capital, the drive to show results and sustain the pace to market is strong.
We envisage a high throughput cell line development approach leveraging Polar HTPD to generate greatly increased cell line selection throughput capacity to meet that demand and accelerate progress through first-in-human (FIH) process creation.
In this scenario, we see Polar HTPD as the glue binding a powerful high throughput bioreactor culture development platform (e.g., Ambr® 250HT) with high throughput analytical methods for product concentration (e.g., Sartorius Octet®), charge profiling and glycan mapping (e.g., Caliper LabChip).
Simplify cell line selection
The Ambr® 250HT and associated laboratory equipment generate large datasets and scientists were spending weeks unpacking, tidying, and organizing ill-formed files and stitching them into a sensible tapestry. Working manually, or with ad-hoc workaround tools, often created by scientists, the process was draining. A sink for time, at best. I won’t be drawn here on the issues around maintainability, transparency, and accuracy that ad-hoc workarounds can create.
Polar HTPD saves cell line development days of effort by automating the combination of Ambr® bioreactor culture results and multiple separate lab devices into a single dataset that’s saved in an online (cloud-native) database ready to be retrieved by third-party applications and your data science team. Your valuable IP is retained and searchable.
When it comes to reporting to investors and senior stakeholders, Tableau is included, and that means it takes only moments to update stunning pre-configured bioreactor culture visuals and export them to PDF or PowerPoint ready for a pressing presentation to share key results and generate commitment.
Biotech is nimble and collaborative, so our bioreactor culture ranking dashboard can be accessed by the entire team at the same time, working together to agree on the best ranking criteria and combine them to create a selection algorithm that is bespoke to the needs of your platform process, molecule, and cell types. Our design has several nods to booking.com and we expect your cell line selection journey to be as simple as applying your insight to find the destination of your dreams.
Discover the power of high-throughput data management today!