Services
Cell Line Development
Cell Line Development Services
Wheeler Bio’s state-of-the-art facilities and highly experienced technical development teams make us leaders in cell line development (CLD). Utilizing the latest CLD technologies in our modern Boston R&D center and Oklahoma City Integrated Process Development Lab, our CLD services are curated to expedite the development of your novel therapy by providing reliability, reducing costs and accelerating timelines.
Mammalian Cell Line Development
Wheeler Bio’s Portable CMC® platform utilizes best-in-class cell line and transposon technologies provided by ATUM™. This innovative bioprocessing offering incorporates the ATUM GeneGPS® and VectorGPS® technologies, embedded in the Leap-In Transposase® expression platform, along with the ATUM miCHO™ host cell line to provide clients with plug-and-play expression optimization. By coupling the ATUM cell line technology with Wheeler’s bioprocess expertise, the Portable CMC® offering provides a tremendously strong and accessible platform that demonstrates speed and predictability from discovery to IND.
Our team also understands that every drug candidate is unique. Wheeler can leverage our experience in cell line development to develop a custom solution designed to optimize your program needs. We have experience working with a majority of CHO expression systems offered on the market today and have successfully implemented alternative CHO expression systems, when needed.
Leveraging our state-of-the-art facility, we provide access to a wide range of technologies and capabilities, including:
Solentim® Ecosystem
Ambr® Technologies
Scale-Up and Purification
Wheeler Bio’s Portable CMC® offering also contains multiple work packages designed to ensure a high-quality final product through material generation and manufacturability assessments in stable bulk cultures (Work Packages 1 & 2), subsequent clone selection (Work Package 3), and cell line stability assessments (Work Package 5).
Cell Line Development Through Portable CMC®
As part of our Portable CMC® platform, we provide drug developers with access to a dedicated service team, optimized vector production with transposon-based gene delivery tools, and highly automated processes for transfection, outgrowth, and pool generation. This ensures efficient, consistent, and verifiable clone isolation, along with genetic stability and manufacturability assessments.
LEARN MORECell Line Development Capabiliites
Our comprehensive cell line development capabilities can support the generation of high-quality, scalable clones for drug substance preparation as part of our Portable CMC® solution through:
A Dedicated Service Team
Gain access to our dedicated service team with over 50 years of combined CLD expertise. They will provide you with the support and guidance you need throughout the process.
High-Titer Compatible CHO-K1 Parental Cell Line
Benefit from access to the ATUM miCHO™ cell line with its expanding regulatory track record, ensuring reliable and efficient cell line development.
Transposon-Based Gene Delivery Tools
We utilize the ATUM Leap-In Transposase®, paired with GeneGPS® and VectorGPS® technologies, to enhance efficiency, performance and quality.
Speed-to-Clinic
Utilize the robustness, speed and predictability of the ATUM Leap-In Transposon® system to optionally produce early representative material for Phase I studies from scalable stable bulk pools.
Automated Workflow
Our highly automated transfection, outgrowth, and pool generation workflow streamlines the process, delivering consistent and efficient results.
Clone Screening and Assessments
We utilize Ambr® 15 for clone screening and offer genetic stability assessment of clones over 60 generations. Optionally, Ambr® 250 can be used for manufacturability assessment.
Comprehensive Reporting
Receive a detailed cell line development report that includes vector sequences, host banking information (not product-specific), cloning traceability, and documentation of clonality.