Selecting the right cell line development technology: data-driven solutions for setting up or enhancing a CLD lab
When establishing or updating a cell line development (CLD) lab, we all look to minimize short terms effects on productivity and to reap new efficiencies as soon as possible. Physical installation time, establishing new workflow validation and even optimizing media and supplements are all factors that can influence the efficiency and economic viability of introducing new equipment. We spoke with Ray Davis, former senior scientist at Seattle Genetics, to hear his views on how a CLD lab can best approach the task of integrating new technology.
Mr Davis, you have worked in this industry for the past 26 years. In your experience, what are the key considerations for CLD scientists when setting up, or updating, a CLD lab?
Introducing a new instrument into a lab will involve much more than just installation. The validation process, media optimization and staff training could, if you choose your vendor poorly, cause significant delays for the lab and reduce workflow productivity. Consulting with an experienced instrument vendor that offers support to the lab that goes beyond just the product, covering training and validation, is absolutely key.
From the outset, you need to have a clear picture of the gains you are looking to achieve. Often, a lab will install a new piece of equipment to answer a specific question or meet a certain need. If it takes 18 months for a new instrument to answer this question due to validation issues, then everyone has a problem – the lab and the vendor, your clients and your managers! Couple this with the fact that most technologies have a shelf life, you want to be able to hit the ground running to get the most out of any new investment.
The plug-and-play nature of Solentim’s technology, along with the comprehensive service and support packages they offer their customers, was a big incentive in choosing them as a vendor for Seattle Genetics.
Over the course of your career what have been the big challenges facing CLD scientists?
Speed and scale. We are all trying to work faster and run more projects simultaneously. During my time there has been a reversal in the way we use cell line development. Previously, the R&D was conducted first, then the cell line development and clonality assurance would take place. Now, many times a clonal cell line is established before work in R&D is completed. This has created a significant increase in demand for CLD and has necessitated CLD labs to run more projects simultaneously.
With this demand comes the need for data management and data security. The STUDIUSTM software from Solentim is a step change for CLD labs, as it allows data to be streamlined, secure, and removes the risk of any data mix-up between projects. This technology also offers enhanced seeding efficiency and maximized colony growth.
New labs have an opportunity to set up right first time, putting in place a lab that is equipped for automation and secure data handling from the beginning. Choosing the right instrument supplier is paramount.
You have worked for both CLD giants and smaller labs; what makes Solentim’s products suitable for both?
The modular business model is the key here. Typically, a CLD lab will receive funding in small instalments. So, you may need your instrument purchase and installation program to be able to mirror the funding schedule without compromising on quality.
With Solentim’s products, you can buy one instrument at a time to work up to the full set – one for seeding, one for whole imaging and one for productivity and selection. If the lab does have the adequate funds to hand, Solentim can cater for this and install all three instruments in one go. For a start-up lab, getting the whole suite monitored through a single data management system offers huge advantages, both scientifically and in communicating with one vendor instead of multiple vendors.
The key here is that there is no compromise of quality. Each unit functions excellently on its own and as part of the ecosystem.
We have talked about how Solentim’s instruments meet various needs, but what sets the technology apart?
More and more, the need to meet regulatory requirements is a focus for CLD scientists. With the regulatory landscape continually evolving, Solentim has designed instruments that generate a clear data output, in both visual and numeric formats, to help meet the expectations of the regulators. The real value of this to CLD labs is that it is one less thing for them to think about. Essentially, we want instruments that work, that don’t take years to validate, and that will meet regulatory requirements. Solentim’s instruments meet all these criteria, allowing labs to put their time and money into the research not the process.
In my experience, Solentim’s instruments are intuitive to use and are backed by years of practical experience. The team has first-hand expertise and understands what you are trying to do, ideally positioning them to help you succeed.
Looking ahead, what do CLD labs need to be focusing on?
New platforms such as stem cell research are gathering momentum, and these new technologies need to start with the end in mind. Stem cell therapy researchers need to be planning for regulatory approval now to avoid a big stumbling block in the future. Again, this is where I feel Solentim has the edge. They are building instruments and software now that will be vital for labs in the future. For example, as soon as stem cell therapies move towards the clinic, evidence of clonality will be required. Solentim has recently introduced the VIPS iPSC in anticipation of this need. If stem cell researchers adopt this technology now, it will position them for regulatory approval more easily in the future.
As with everything else, technology is always evolving and improving, and CLD scientists need to have their eyes open to new advances that could same them time and money. We need to move with the times and address the regulatory requirements; Solentim has prioritized this in their product development, and it is paying off.
About Ray Davis
Ray Davis has worked as a CLD scientist since 1995. Primarily based in the lab, he has worked across small organizations and large companies, including Amgen and CMC Biologics. More recently, he spent five years as a Senior Scientist at Seattle Genetics, during which time he helped bring the company up to speed with CLD automation technology. He now operates as a CLD consultant.