Conquer the High-Stakes Climb to Successful Cell Line Development
Cell line development is vital to biologics manufacturing, but the journey is time-consuming, expensive, and requires dedicated expertise. For any biotech company, the huge task of establishing a successful bioprocess is on par with climbing Mount Everest. So, do you go at it solo or hire a Sherpa?
This article is posted on our Science Snippets Blog.
Summiting Mount Everest
Living cells are the production hubs of biopharmaceutical products—in fact, 84% of approved biologics over the last four years were made in mammalian cells.
Creating a reliable cell line development bioprocess that can get you across the finish line is no walk in the park. You need robust, high-yielding cell lines that meet strict regulatory standards and can be scaled for commercial manufacturing. Achieving this is a huge technical and logistical undertaking, especially for an early-stage company.
Where do you begin? How do you select the right technologies and experts? How do you avoid the cracks and crevasses? This is where having a reliable guide becomes vital.
Planning for the Big Climb
Sartorius dominates this space with custom solutions to help you make the trek. Of course, the needs of every company are unique; some have the resources to do it all in-house, while others rely exclusively on outsourcing. The vast majority, however, need both.
You can think of us as the choose-your-own-adventure guide of cell line development. We work closely with you to create a tailored plan that includes industry-leading technologies and full-service packages designed to save you time.
Let Us Start at Base Camp
The cell line development workflow begins with transfection of the cell line with the gene of interest and accurately identifying the top pools. There are so many ways to go about this. Our iQue® Advanced Flow Cytometry Platform allows for fast cell health and viability monitoring, and with the Octet® Label-Free Biomolecular Interaction Analysis, one can detect the titer of the expressed proteins in their crude matrix. With all of the necessary components needed to get started, our plug-and-play Cellca Cell Line Technology License increases the probability of success by delivering a mature, high-performing cell line to reduce timelines and financial investment. Alternatively, save your resources by relying on our experienced team with over 240 CLD projects to take your DNA to cGMP Master Cell Bank with our cell line development services.
We can tailor a customer's cell line development journey for a more flexible process by combining our innovative technologies with our knowledgeable service team to complement your facility’s core strengths. Leverage the right people and products when and where you need them to accelerate your cell line development process and pace to the top.
Proceed with Confidence
Next up is screening for the best clones and verifying that the protein products have all the required physical and functional characteristics or Critical Quality Attributes (CQAs). Doing this early is critical for avoiding costly setbacks down the line. The Octet® BLI System for real-time, label-free biomolecular analysis is a true powerhouse for this workflow step.
Our consultants will explain the capabilities of the Octet® BLI Systems, as well as ready-to-use high-throughput assays for glycan screening and protein quantitation. The ability to quickly screen proteins for CQA, even from crude samples, makes the Octet® an effective decision-making tool for in-house workflows.
The Final Ascent
Before ramping up for manufacturing, cell culture conditions must be optimized for high protein titers. We will guide you through choosing between in-house solutions, or process-integrated services for outsourcing all media optimization. And when you are ready to bank your lead clones, the Sartorius CHO cell banking platform and custom biosafety testing packages will pave the way forward.
The climb to successful cell line development is steep and can be hard to predict. We will help you pick the most advanced tools, connect you with experts who know the workflow, and make sure you have everything you need to ensure a successful journey to commercialization.
Read our latest White Paper for more about the challenges of cell line development and how to position yourself for a reliable production process. Contact us when you are ready to expand your workflow capabilities and embark on your cell line development journey.