Comprehensive Immune Cell Therapy Solutions

Media and Buffer Prep

Challenge: Media handling is complex, and unwanted impurities risk contaminating your media or buffer.

Solution: Simplify, automate, and de-risk your media and buffer preparation processes.

Highlighted products|services:

• Linkit^® AX: Make your aseptic filling 10X faster with our plug-and-play aliquoting solution.

• Biowelder^® S: automated and GMP-compliant welding of PVC and TPE tubing with small diameter commonly used in CGT processes.

• Sartopore^® 2 filters: Ensure sterile filtration using sterilizing-grade heterogeneous double-layer filters available in 0.8 and 0.45 μm pre-filter and a 0.2μm final filter membrane.

• Virosart^® Media: Mitigate viral contamination using a viral retention filter designed for cell culture media.

• Confidence^® Validation Services: Comply with regulatory requirements using services backed by more than 25 years of industry experience.

• Flexsafe^® 2D and 3D bags: Support all fluid handling and transportation steps for drug manufacturing from 20 mL to 3,000 L.

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Donor Material Sample | Cell Isolation | Cell Activation

Challenge: Cells exhibit low viability, low recovery, and reduced functionality during isolation and activation processes.

Solution: Confidently isolate, preserve, and activate your immune cells using high-performing reagents.

Highlighted products:

• Immune cell media: Simplify your process, reduce serum-associated risks, and ease regulatory procedures using media designed and optimized for culturing immune cells.
• Preclinical- and GMP-grade cytokines: Choose from a variety of high-quality cytokines trusted by scientists in immune cell therapy.
• NutriFreez^® D5 & NutriFreez^® D10 cryopreservation media: Enable short- and long-term cryopreservation that provides high performance and recovery after freezing.
• NanoSpark^® immune cell activators: Activate immune cells with robustness for the desired phenotypes while reducing overstimulation risks in CAR-T cells or eliminating feeder cells in NK cell therapy.

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Gene Editing

Challenge: Today’s gene editing technologies and delivery tools have limited precision and efficiency.

Solution: Simplify and tailor your process for non-viral gene delivery and transduce your cells with high-quality vector using our lentivirus solutions.

Highlighted products:

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• Lentiviral vector production.
• LipidBrick^® Cell Ready is a ready-to-use cost-efficient, scalable and efficient lipid-based nanoparticles for ex vivo transfection of immune and stem cells.

Cell Expansion

Challenge: Scientists need to achieve efficient, consistent, and scalable expansion of target cell types while maintaining cell viability and functionality.

Solution: Achieve robust and scalable expansion of a variety of target cell types - including T cells, Tregs, TILs, dendritic cells, and natural killer cells — with a wide selection of advanced equipment and high-quality raw materials and reagents.

Highlighted products:

• Ambr^® , Biostat STR^® and Univessel^® single-use bioreactors: Achieve automation and high throughput with single-use commercial-scale bioreactors. For processes requiring GMP compliance, we recommend the Biostat STR^® bioreactor.

• Immune cell media: Simplify your process, reduce serum-associated risks, and ease regulatory procedures using media designed and optimized for culturing immune cells.

• Preclinical- and GMP-grade cytokines: Choose from a variety of high-quality cytokines trusted by scientists in immune cell therapy.

• Recombumin^® rHA: Support your therapy development with commercially available, high-quality, and animal and human origin-free recombinant human albumins.

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Analytics

Challenge: Manually identifying and optimizing critical process parameters and quality attributes during development and scale-up is inefficient and time-consuming.

Solution: Enable fast, accurate, and robust process control using optimized analytics, including design of experiments (DOE) and multivariate data analysis (MVDA) software.

Highlighted products|services:

• MODDE^® DOE software: Accelerate progress by quickly tapping into the power of DOE.

• SIMCA^® MVDA software: Improve process understanding, model complex systems, and gain the deep process understanding needed to drive growth.

• Fresh and spent media analysis: Monitor the effects of feed strategy and media components on cell culture performance.

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Harvest

Challenge: Scientists need to maintain sterility and cell quality during harvest while maximizing cell yield and viability.

Solution: Reliably harvest and wash immune cells using fast, high-performing, and scalable solutions that ensure high yield, viability, and quality.

Highlighted products:

• Ksep^® systems: Deliver high cell viability and recovery using single-use and low shear counterflow centrifugation systems.

• Recombumin^® rHA: Support your therapy development with commercially available, high-quality, and animal- and human-origin-free recombinant human albumins.

• Flexsafe^® 2D bags: Protect critical fluids throughout production with extensively qualified bags for cell and gene therapy.

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Formulation, Fill and Finish

Challenge: Thawing and storage risk reducing cell recovery and viability.

Solution: Ensure high recovery and viability with controlled freeze-thaw processes, optimized cold storage, and validated shipping solutions for long- and short-term storage and transportation of sensitive cells.

Highlighted products:

• Celsius^® freezing platform: Ensure reliable cold-chain operations with a single-use freeze-and-thaw system that works with your existing infrastructure.
• Recombumin^® rHA: Support your therapy development with commercially available, high-quality, and animal- and human-origin-free recombinant human albumin.
• NutriStor^® cold storage solution: Store and ship cells without compromising their stability.
• NutriFreez^® D5 & NutriFreez^® D10 cryopreservation media: Enable short- and long-term cryopreservation that provides high performance and recovery after freezing.
• Flexsafe^® 2D for fill & finish: Protect critical fluids with bags extensively qualified for final filling of cell and gene therapeutics.

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