Workflow
Cell Line Development
The new standard for quality, capacity, and speed
Presentation
Clone, Culture, Assay and Select Top Clones
on a Single Platform
BEYOND TITER: Identify Top Producers with Favorable Product Quality Attributes within 5 Days of Cloning
BEYOND TITER: Identify Top Producers with Favorable Product Quality Attributes within 5 Days of Cloning
CHO cell line selection is a painful bottleneck in biotherapeutic development, particularly for complex molecules like bispecifics. The Opto® CLD workflow on the Beacon® and Beacon Select™ systems accelerates early CLD by integrating high throughput cell sorting, cloning, culture, productivity, growth, and product quality assays into a single, 5-day automated process. Hear about capabilities of on-chip detection that pinpoints best clones early on.
DATASHEET
The Opto® Cell Line Development Workflow
Cell Line Development (CLD) on the Beacon® and Beacon Select™ optofluidic systems enables high throughput cloning, screening, and selection of top-performing CHO cell lines in just days. Used globally by leading pharmaceutical companies and CDMOs, the Beacon systems’ industry-leading technology delivers unrivaled speed and efficiency to cell line development workflows. The Opto® CLD workflow has enabled customers to select clones with higher titers than traditional methods (Customer Spotlight: Catalent), increase throughput by 4X while reducing their cell line development timeline by up to 50% (Customer Spotlight: Mycenax), and recover clones with >99% monoclonality assurance to support FDA IND regulatory filings (Application Note: FDA Accepted IND). In addition, the Opto™ Assure quality assays enable users to select clones with favorable product quality attributes within 5 days of cloning to reduce overall costs, improve the probability of success, and further shorten timelines by selecting top clones for scale up.
Deliver the best cell lines
Set your IND up for success by getting FDA-accepted monoclonality assurance in just days.
customer webinars
Workflow In Action
See how our customers apply our CLD workflow to streamline cell line development and get to the clinic faster.
Featured:
Thermo Fisher Scientific on: “Leveraging Innovative Technologies to Accelerate Biologics Development”
Watch More:
Fireside chat with Catalent, University of Queensland, and Amgen
Select for Even the Most Complex Molecules in Just Days
Replace 8-12 weeks of challenging well plate steps with Opto® CLD on the Beacon® and Beacon Select™ optofluidic systems.
Screen thousands of clones in parallel and select top clones for even non-traditional antibody molecules, like bi-specifics.
Selection Based on Product Quality, Not Just Productivity
Get to production faster with Opto™ Assure for early manufacturability assessment.
ASSAY FOR AGGREGATION
Opto™ Assure minimizes risk of costly late stage failures by identifying clones early on that secrete product with high yield and desired quality. Opto Assure assay for aggregation enables direct detection of product aggregates within days of single cell cloning. This lets you confidently identify and select clones that secrete high-quality complex molecules and develop better production cell lines faster.
>99% monoclonality assurance
Get >99% monoclonality assurance with a single, automated round of cloning.
The Berkeley Lights Opto CLD workflow enables in-line controls to measure clonality during clone recovery. After recovery of each clone, media is flushed into “blank” wells to detect any residual cells. Expand >90% of selected clones from the Beacon system when recovered into 96-well plates, with >99% monoclonality assurance – which is equivalent to four rounds of limiting dilution!
Bulk stable pool to rare, top quality clones in one week
Access to more relevant cell diversity with Selective Cell Cloning.
Selective Cell Cloning with Opto CLD lets you screen up to 100,000 cells in a single 5-day workflow, enabling access to more relevant cell diversity than conventional methods for cell line development. Gently enrich transfected pools by identifying and cloning only cells that are viable and express your protein of interest. With Selective Cell Cloning, you can eliminate weeks of mini-pool processing by enabling deeper screening of bulk stable pools.
CONFIDENT CLONALITY ASSURANCE
FDA-accepted clonality assurance for a successful IND
The Beacon system’s optofluidic chip technology and integrated imaging provide direct evidence of >99% monoclonality, without manual effort and uncertainty of traditional methods. Learn how the Opto CLD workflow provides superior cloning technology and in-process quality controls for definitive evidence of monoclonality to support regulatory approvals.
Export the best from 1000s of clones
The Opto CLD Workflow enables selection of top clones by measuring growth over multiple days of on-chip culture and secretion titers using quantitative assays for both traditional and non-traditional antibodies.
- Measure antibody production from 1000s of clones
- Quantify secretion titers and specific (per-cell) productivity using the SpotLight™ Human Fc and SpotLight™ Human Kappa reagents
- Enrich and recover top-secreting clones for scale-up
SpotLight assay: Simultaneous, quantitative antibody titer measurements on thousands of clones (LEFT). Clones selected based on titer measurements on the Beacon system had 1.5–3-fold higher titers than clones selected using traditional clone picking technology when scaled up to shake flask fed-batch cultures (RIGHT). ©2019 Catalent, Inc. All rights reserved.
Related Resources
View All Cell Line Development ResourcesDATASHEET: Opto® Cell Line Development Workflow
- Selective Cell Cloning for better clones and accelerated campaign timelines
- Custom Productivity Assay for selection of cell lines expressing a wide range of therapeutic proteins and vaccines
BROCHURE: Beacon Select™ Optofluidic System for CLD
- Approximately half the price of the 4-chip Beacon system
- A 2-chip automated optofluidic system, similar to the 4-chip Beacon® optofluidic system, which provides well-established workflows that have been adopted by ~130 customers
- Throughput scaled to meet the needs of small to mid-sized biopharma and CDMO/CRO companies
Brochure: Get to Market Faster with the Opto CLD Workflow
Find out how the Opto CLD workflow sets a new standard for quality, capacity, and speed in cell line development to let BioPharma get more molecules to the clinic faster.
Brochure: Increase CDMO Revenue with the Opto CLD Workflow
Find our how the Opto CLD workflow sets a new standard for quality, capacity, and speed in cell line development and allows CDMOs to scale operations and drive new business.
Fireside Chat: Every Day Matters – Optimizing COVID-19 Therapies for Manufacturing
Dr. James Rothman, Nobel Laureate hosts an in-depth discussion with distinguished guests, Dr. Jennitte Stevens from Amgen, Dr. Gregory Bleck from Catalent-Biologics, and Dr. Trent Munro from the University of Queensland on fast-tracking the development of therapeutic antibodies and vaccines for SARS-CoV-2.
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