Accelerate Scalable Cell Therapy Manufacturing

Optimizing cell therapy manufacturing Join forces with the trusted pioneer of scalable bioprocessing solutions to advance your therapy from process development to commercialization your processes with clinically proven cell therapy solutions Cell therapy 2 thermofi sher.com/gibco-cell-therapy Cell therapy is one of the most exciting and dynamic fi elds in modern medicine. Like you, we believe in the promise of cell therapies to cure what was once thought of as incurable. And, like you, we know that this begins with careful material selection and thoughtful process development. That is why our goal is to help you further your progress and support your journey to success. This journey begins with isolating, activating, and expanding your target cells. Thermo Fisher Scientifi c has the high-quality reagents, instruments, services, and technical support to enable you to take the fi rst steps in your cell therapy workfl ow with confi dence. Advancing your cell therapy 3 thermofisher.com/gibco-cell-therapy Supporting safety and efficacy with high quality standards Driven by quality and innovation, we have been solving complex bioprocessing challenges for 60 years. Gibco™ products are manufactured to good manufacturing practices (GMP) to help consistently enhance performance, with our quality management systems and policies designed to help meet your ever-changing needs. With registered ISO-certified and state-of-the-art facilities strategically located around the world, we can support our customers globally and deliver continuity of supply with our highest quality products. Our cell therapy products are part of the Gibco™ Cell Therapy Systems (CTS™) portfolio. These high-quality, cGMP-manufactured products offer a proven choice for research and manufacturing, helping developers transition to the clinic with confidence. With serum-free and xeno-free options, CTS products help minimize risk and support regulatory submission. When you choose CTS products, you can expect: cGMP manufacturing • Manufactured in conformity with GMP and 21 CFR Part 820, following USP<1043> and Ph. Eur. 5.2.12 guidelines • Manufacturing sites that are FDA-registered, ISO 13485–certified, and regularly audited Testing and documentation • Traceability documentation, including Drug Master Files (DMFs) and/or Regulatory Support Files (RSFs) and certificates of origin to help expedite your cell therapy to market • Product safety testing, including sterility, endotoxin, and mycoplasma testing of media and reagents Proven use • Used in FDA-approved and EMA-approved CAR T therapies and the first FDA-approved therapeutic cancer vaccine • Used in over 200 clinical trials 4 thermofisher.com/gibco-cell-therapy Cell therapy instrumentation for any stage or scale Isolating your target cells with precision is the first step. Whether you are working at a small scale or ready to move to process development for clinical and commercial manufacturing, our fit-for-purpose Gibco™ CTS™ DynaMag™ Magnet and Gibco™ CTS™ DynaCellect™ Magnetic Separation System can help you in your cell therapy manufacturing journey. Combined with the Gibco™ CTS™ Dynabeads™ portfolio, these offerings are well suited for both autologous and allogeneic applications. For those in the discovery phase, we offer the CTS DynaMag Magnet, which is designed for positive isolation, magnetic separation, and expansion of T cells with Gibco™ CTS™ Dynabeads™ CD3/CD28 beads and for activation and expansion of regulatory T cells (Tregs) with Gibco™ CTS™ Dynabeads™ Treg Xpander. Key features include: • Optimized for magnetic isolation in closed, sterile blood bags • Scalable volumes: 50 to 330 mL in static separations and >10 L in continuous flow separations following T cell expansion protocols • Residual beads that escape initial magnetic capture are retained on a secondary magnet CTS DynaMag Magnet 5 thermofi sher.com/gibco-cell-therapy CTS DynaCellect Magnetic Separation System Whether you started your research using the CTS DynaMag Magnet or another instrument, the CTS DynaCellect Magnetic Separation System is a fl exible, automated, and closed platform that will help you achieve rapid isolation of target cells and effi cient removal of magnetic Dynabeads beads. As a stand-alone instrument or as part of a workfl ow, the operator-independent system will help you isolate the right cells and minimize failures in manufacturing while providing increased robustness and precision. Key features include: • Isolation effi ciency, purity, and viability: >86% isolation effi ciency of target cells with >96% purity and no eff ect on cell viability when used with CTS Dynabeads CD3/CD28 beads • Speed: Isolation processing time of 70–100 minutes with CTS Dynabeads CD3/CD28 beads • Flexibility: User-programmable software to create and optimize a broad range of protocols • Modularity: Use independently or as part of your workfl ow; the system can be digitally integrated with other instruments through Gibco™ CTS™ Cellmation™ software • Scalability: Designed for research through to commercial manufacturing • Open Platform Communications-Unifi ed Architecture (OPC-UA) interface enables connectivity to a 21 CFR Part 11–compliant system The CTS DynaCellect system delivers high isolation effi ciency, recovery, and viability from process development to commercial manufacturing when used with the off -the-shelf, sterile, single-use consumables. A B Figure 1. Strong isolation effi ciency with minimal impact on cell viability. Using CTS Dynabeads CD3/CD28 magnetic beads and the CTS DynaCellect Magnetic Separation System, isolation effi ciency was greater than 85% (A) and cell viability was maintained at ~87% (B) as determined by fl ow cytometry. Isolation eciency (%) Cell viability (%) 100 Donor 1 Donor 1 Average 90 80 70 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 Donor 2 Donor 3 85.9 87.4 87.3 Donor 4 Starting cells Isolated cells Isolation eciency (%) Cell viability (%) 100 Donor 1 Donor 1 Average 90 80 70 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 Donor 2 Donor 3 85.9 87.4 87.3 Donor 4 Starting cells Isolated cells 6 thermofi sher.com/gibco-cell-therapy Gibco™ CTS™ DynaCellect™ Cell Isolation Kit The CTS DynaCellect Cell Isolation Kit is specifi cally designed for the isolation and/or activation of target cells in cell processing applications. Key attributes of the kit include: • Maximum capacity: 1,000 mL • Enables isolation to be carried out in either a class B or C cleanroom • Eight weldable lines for input and output bags: DEHP-free PVC connections (150 mm, 2.4 mm ID, 4.0 mm OD) • Sterile air fi lters: 0.20 micron • Gamma sterilized • OPC-UA interface enables connectivity to a 21 CFR Part 11–compliant system Gibco™ CTS™ DynaCellect™ Bead Removal Kit The CTS DynaCellect Bead Removal Kit is specifi cally designed for bead removal from target cells for cell processing applications. Key attributes of the kit include: • Continuous processing volume • Enables bead removal to be carried out in either a class B or C cleanroom • Four weldable lines for input and output bags: DEHP-free PVC connections (150 mm, 2.4 mm ID, 4.0 mm OD) • Sterile air fi lter: 0.20 micron • Gamma sterilized Designed to be used with the CTS DynaCellect system, we also off er a range of Dynabeads beads for cell isolation, activation, and expansion. 7 thermofi sher.com/gibco-cell-therapy CTS Dynabeads CD3/CD28 beads CTS Dynabeads CD3/CD28 beads are designed for ex vivo isolation, activation, and expansion of human T cells. By combining anti-CD3 and anti-CD28 antibodies, the beads produce the primary and costimulatory signals needed for isolation and activation of T cells. This one-step process of simultaneous T cell isolation and activation yields pure and uniformly activated T cells. CTS Dynabeads CD3/CD28 beads then expand the CD4+ and CD8+ T cells while maintaining an early memory phenotype. After being genetically modifi ed, the activated T cells can be expanded in one of the Gibco™ CTS™ OpTmizer™ serum-free media. Either the CTS DynaMag Magnet or the CTS DynaCellect system can be used for bead removal. CTS Dynabeads CD3/CD28 beads deliver reliable results and have been used in more than 100 clinical trials and in commercial T cell drug manufacturing. Figure 2. Activated T cells typically expand >100-fold in 10 days (A). Isolated and activated T cells were expanded for up to 10 days, and the ratio of CD4+ and CD8+ T cells was measured (B). Fold expansion CD4:CD8 ratio 1,000 800 600 400 200 10 8 6 4 2 0 Day 3 Day 10 3 2 1 0 Day 3 Day 10 A Fold expansion CD4:CD8 ratio 1,000 800 600 400 200 10 8 6 4 2 0 Day 3 Day 10 3 2 1 0 Day 3 Day 10 B Achieving high cell purity with the CTS DynaCellect Magnetic Separation System Situation: A customer was having diffi culty achieving improved cell purity. Solution: Provided with the CTS DynaCellect system, CTS DynaCellect Cell Isolation Kit, and detailed protocol, the customer improved cell purity to 78% following initial failed runs. We worked closely with the customer to provide technical support and optimization solutions. The starting material was particularly challenging, with high monocyte levels at 35.6%. After T cell enrichment, the monocyte levels were reduced to 0.1%. Results: Following optimization, the customer was able to achieve 92.9% cell purity during the third and fi nal run. These impressive results were enabled by the CTS DynaCellect system and the close technical support provided. Case study 8 thermofi sher.com/gibco-cell-therapy Figure 3. Strong suppression of T eff ector target cells by expanded Tregs. Suppressive potential declines with increasing amounts of target cells. Suppression (%) Treg:target cells Vial 1 Vial 2 120 100 80 60 40 20 0 1:1 1:2 1:4 1:8 1:16 1:32 Gibco™ CTS™ Dynabeads™ Treg Xpander Tregs are a subpopulation of T cells with the unique ability to suppress the activation of eff ector T cells and thereby prevent T cell function. CTS Dynabeads Treg Xpander has been optimized for the ex vivo activation and expansion of Tregs, with optimal phenotype and function for cell therapies. These CTS Dynabeads beads provide a specifi c activation signal for high fold expansion of Tregs, resulting in a high cell yield and suppression of conventional T cells. This is essential for the treatment of autoimmune diseases. CTS Dynabeads Treg Xpander provides more specifi c and higher fold expansion compared to CTS Dynabeads CD3/CD28 beads. Dynabeads Human T-Expander CD3/CD28 is the research-grade version of CTS Dynabeads CD3/CD28 beads. These Dynabeads beads contain the same amount and ratio of antibodies from the same clones as CTS Dynabeads CD3/CD28 beads, with the Dynabeads beads providing both the primary and co-stimulatory signals that are required for activation and expansion of T cells. CTS Dynabeads Human T-Expander CD3/CD28 is intended for small-scale, preclinical research. Gibco™ Dynabeads™ Human T-Expander CD3/CD28 thermofi sher.com/gibco-cell-therapy is the research-grade version of CTS Dynabeads CD3/CD28 beads. These Dynabeads beads contain the same amount and ratio of antibodies from the same clones as CTS Dynabeads CD3/CD28 beads, with the Dynabeads beads providing both the primary and co-stimulatory signals that are required for activation and expansion of T cells. CTS Dynabeads Human T-Expander CD3/CD28 is intended for small-scale, preclinical research. 9 thermofi sher.com/gibco-cell-therapy Coming soon to the market is a next-generation platform of CTS Detachable Dynabeads beads that possess a proprietary active release mechanism, the fi rst and only of its kind with a bead and release buff er for GMP, clinical, and commercial manufacturing use. These new off erings are directly intended for use with the CTS DynaCellect system and the fi rst wave of launches are focused on T cell isolation and/or activation: • Gibco™ CTS™ Detachable Dynabeads™ CD3/CD28 Kit (available 2023) • Gibco™ CTS™ Detachable Dynabeads™ CD4 Kit (available 2024) • Gibco™ CTS™ Detachable Dynabeads™ CD8 Kit (available 2024) With its active release mechanism and high specifi city, our CTS Detachable Dynabeads platform allows for signifi cant fl exibility and scalability of manufacturing processes that vary widely from one therapy to another. Its performance exhibits consistent and optimal isolation, activation, and purity of target T cell populations while addressing the biological variability that cell therapy manufacturers are facing. The CTS Detachable Dynabeads beads are based on our existing paramagnetic bead technology, but conjugated to highly specifi c, single-domain VHH antibodies that target specifi c clusters of diff erentiation (CD) markers for isolation and/or activation. Each kit comes with an active release buff er enclosed in a CTS DynaCellect system–compatible bioprocess container. After isolation of target immune cells and magnetic separation in the CTS DynaCellect system, the release buff er allows a user to actively detach target cells from the CTS Dynabeads beads through a competitive binding mechanism. This innovative portfolio is designed to help accelerate current cell therapy manufacturing processes, while driving the next generation of cell-based therapies. Benefi ts of using CTS Detachable Dynabeads beads include: • Compatibility with our automated instruments and workfl ows • Flexibility with downstream gene modifi cation target cell purity and yield, helping reduce time and costs for other reagents • Shortens cell therapy manufacturing, helping save resources and time-to-patient • Low residual ancillary material helps reduce regulatory burden and contributes to patient safety • Standard testing and documentation helps lower regulatory hurdles for both autologous and allogeneic applications • cGMP compliant Gibco™ CTS™ Detachable Dynabeads™ beads Seamlessly integrating automated bead removal Situation: A customer had an established workfl ow utilizing the CTS DynaMag Magnet but was interested in automating bead removal to support a consistent and reliable workfl ow, with operator-independent results. Solution: The customer was provided with the CTS DynaCellect system, along with the CTS DynaCellect Bead Removal Kit and protocol. As the existing workfl ow was already optimized for Gibco products, the automated system was easily incorporated with no challenges around technology transfer. Results: Using the CTS DynaCellect system, the customer was able to achieve comparable cell recovery to the CTS DynaMag Magnet, at around 90%. The customer was also able to reach around 95% cell viability, exceeding its criteria of 90%. Crucially, bead removal time was signifi cantly reduced, as the CTS DynaCellect system accelerated the debeading process from two hours to <30 minutes, without impacting cell recovery. Shortening this process and minimizing handling enables developers to accelerate throughput, maximize consistency, and streamline the cell therapy manufacturing workfl ow. Case study 10 thermofisher.com/gibco-cell-therapy T cell media Following bead removal and gene editing of target cells, the cells must be expanded. It is important to select a medium that is specifically made for the cell type you are using. Our media are specifically designed for high-density human T lymphocytes (e.g., CD4+, CD8+, polyclonal, or antigen specific) and are serum-free and xeno-free. All our media maintain the desired central memory phenotype. 11 thermofi sher.com/gibco-cell-therapy Time in culture (days) Fold expansion 200 1A 1B 1C 2A 2B 2C 3A 3B 3C 150 100 50 0 0 2 4 6 8 10 Time in culture (days) Fold expansion 20 40 60 80 100 0 0 2 4 6 8 10 Competitor, HS CTS OpTmizer SFM, ICSR CD8/CD4 0.6 0.5 0.4 0.3 0.2 0.1 0 Competitor, hABs CTS OpTmizer SFM, ICSR CD8/CD4 0.6 0.5 0.4 0.3 0.2 0.1 0 Competitor, hABs CTS OpTmizer SFM, ICSR CD8/CD4 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0 Time in culture (days) Fold expansion 20 40 60 80 100 120 140 0 0 2 4 6 8 10 CTS OpTmizer SFM, ICSR Competitor, hABs CD62L/CCR7 % of CD3+ population -/- -/+ +/- +/+ 60 50 40 30 20 10 0 CD62L/CCR7 % of CD3+ population -/- -/+ +/- +/+ 10 20 30 40 50 60 70 80 0 CD62L/CCR7 % of CD3+ population -/- -/+ +/- +/+ 10 20 30 40 50 60 70 80 0 CTS OpTmizer SFM, ICSR Competitor, hABs Figure 4. T cells were cultured in CTS OpTmizer SFM, no phenol red, with Gibco™ GlutaMAX™ Supplement and 2.5% Gibco™ CTS™ Immune Cell Serum Replacement (ICSR) for 10 days in (1) G-Rex vessels, (2) static culture bags, and (3) the Thermo Scientifi c™ HyPerforma™ Rocker platform. For all vessels, (A) cell growth was measured over time and reported as fold expansions. (B) Phenotypic characterization was performed on day 10 to determine the CD8:CD4 ratio and (C) the degree of diff erentiation, as measured by CD62L and CCR7 expression within the CD3+ population. These tests employed competitor media containing 5% hABs as a benchmark. Data represent the mean of three experimental replicates and error bars are the standard deviations of each data set. CTS OpTmizer T Cell Expansion SFM, no phenol red, has been developed for the growth and expansion of human T lymphocytes for autologous therapies. This complete serum-free, xeno-free 1X medium consists of a basal medium and an expansion supplement, which are mixed prior to use. The medium has demonstrated successful T cell expansion in cell culture plates up to large-scale bioreactors as eff ectively as a serum-containing medium. Benefi ts of the medium include: • Maintains similar phenotype and function (e.g., cytokine secretion profi le) of polyclonally activated and cultured T cells as observed for conventional serum-supplemented medium • Consistent performance in supporting T cell expansion • Supports high density T cell culture (e.g., >3 x 10⁶ CD3+ T cells/mL) in static culture • Designed to support expansion of cultured human T cells without additional serum supplementation • Supports T cell expansion in G-Rex™ vessels (Wilson Wolf), static culture bags, and rocking bioreactors as well as serum-containing medium Gibco™ CTS™ OpTmizer™ T Cell Expansion Serum Free Medium (SFM), no phenol red 12 thermofi sher.com/gibco-cell-therapy CTS OpTmizer Pro SFM is a novel medium, developed for the growth and expansion of human T lymphocytes for allogeneic cell therapies. CTS OpTmizer Pro SFM improves central memory phenotype and cell growth by shifting the cell’s metabolism, resulting in a larger population of central memory cells in a shorter timeframe. Medium benefi ts include: • Maintenance of central memory T cells further into expansion, which is well suited for longer workfl ows (>15 days) • Modest increases in central memory cells at early stage in the expansion protocol result in larger cell yields at harvest • Capability of achieving the same number of cells in a shorter duration • Being ideally suited to the production of allogeneic therapies Gibco™ CTS™ OpTmizer™ Pro SFM Figure 5. T cell diff erentiation pathway—younger is better. This diagram illustrates the spectrum of T cell diff erentiation, with the less diff erentiated and most therapeutically desirable young T cells (TCM ) on the left and mature T cells (TEM and TEFF ) on the right. Phenotypic changes that follow antigen stimulation are shown to demonstrate T cell diff erentiation and subset population changes. Supply chain optimization: Managing risk with serum-free media Situation: A clinical-stage biopharma company was looking to improve its CAR T cell therapy manufacturing methods. The aim was to reduce the use of human serum to minimize risk of viral contamination. The customer was also interested in utilizing a fully defi ned medium with minimal lot-to-lot variability to enable more consistent manufacturing. Solution: We were able to provide cGMP-manufactured, fully defi ned, and serum-free formulations. This included: • CTS Immune Cell Serum Replacement, supporting expansion of polyclonal T cells • CTS OpTmizer T Cell Expansion SFM • IFN-γ ELISA assays for determining functional potency of CAR T cells Results: With the solutions provided, the customer achieved expansion analogous to cells grown in human serum. Risks were minimized by eliminating human serum and the customer achieved increased consistency in cell manufacturing processes under cGMP standards. The customer has continued to use CTS media and supplements in its cell therapy manufacturing process. Case study 13 thermofisher.com/gibco-cell-therapy Normalized increase in %TCM 0 0 5 10 15 20 25 30 35 Day 5 Day 10 CD62L+/CCR7+ CD62L+/CD27+ Normalized fold expansion Days post-activation Donor 1 0 0 2.5 2.0 1.5 1.0 0.5 2 4 6 8 10 12 14 16 18 Donor 2 Donor 3 Donor 4 Donor 5 Donor 6 CTS OpTmizer Pro SFM average Control medium average Figure 7. CTS OpTmizer Pro SFM maintains TCM phenotype of healthy donor cells. Six healthy donor cells tested in an 18-day allogeneic workflow utilizing CTS OpTmizer Pro SFM demonstrated a 10–20% increase in the size of the central memory subset when evaluated on days 5 and 10, following normalization with a control medium. TCM cells express CD62, CCR7, and CD27 as indicated. Figure 6. Normalized proliferation data in CTS OpTmizer Pro SFM in an 18-day workflow with cells from six healthy donors. Healthy donors’ cells tested in CTS OpTmizer Pro SFM demonstrated ~20% higher cell proliferation by day 10, with a ~100% increase by day 17, when compared to a control medium. The average normalized change in cell growth in CTS OpTmizer Pro SFM is represented by the light blue line, with the baseline standard shown in dark blue and individual donors shown in light gray. Fold expansion Time in culture (days) Stirred tank bioreactor 0 0 300 200 100 2 4 6 8 10 Static control bioreactor Rocking motion bioreactor Figure 8. Fold expansion comparison of T cells in three different bioreactors. Greatest fold expansion was achieved in the stirred tank bioreactor, followed by the rocking motion bioreactor and static bioreactor. 14 thermofisher.com/gibco-cell-therapy Custom media and packaging for your unique needs As variation in workflows increases, it is important to use media and feeds tailored to your process goals. We offer integrated solutions across the workflow, including custom packaging and media capabilities that have the ability to scale with you as your project grows. Our commercial team and project management office (PMO) can help you customize either your own medium formulation or a catalog formulation, in bottles or bags. They can also help you add or remove components, change concentrations, and guide you through in-depth analytics, with the Gibco™ Media by Design™ services. Alongside media customization, we also offer full packaging flexibility. Leveraging Gibco product quality and processes to support your needs, our team can guide you to optimize packaging that will work best in your facility. Our highly skilled team of engineers can develop custom packaging solutions that help maximize ease of use and enable you to seamlessly integrate Gibco products into your process. We offer packaging solutions for liquid and dry powder media formats, as well as our proprietary Gibco™ Advanced Granulation Technology™ (AGT™) media format. AGT media offer high consistency and performance across all stages of production, enabling increased productivity, reduced costs, and enhanced scale-up, while maintaining comparable cell growth to liquid media formats. Production capabilities • Pilot-scale production capabilities in Grand Island, NY • cGMP manufacturing available in both Grand Island, NY, and Inchinnan, Scotland • Liquid and powder production Quality and regulatory • Battery of QC testing to ensure product quality (sterility, mycoplasma, endotoxin, etc.) • Intended use and labeling determination • Potential to reference DMFs for catalog formulations Support • Commercial team ready to support your needs • Dedicated PMO available to guide you through your custom order process 15 thermofi sher.com/gibco-cell-therapy When you choose Media by Design services, our dedicated global team of experts can assess your project’s unique needs and help create a customized solution to address your goals. Combining our extensive bioprocessing knowledge with our portfolio of innovative, trusted Gibco products and services, we can help empower your bioprocessing success. Once your process has been established, you can also utilize our cGMP media manufacturing services to help streamline your transition to commercial production. Complex formulations, novel raw materials, and custom packaging may increase manufacturing times. Media by Design services Services spotlight: Gibco rapid prototyping services Gibco™ rapid prototyping services off er high-quality custom media to rapidly fi nalize your formulations before cGMP scale-up. With our responsive customer service and experienced production team, your custom medium can be shipped in as few as 10 days after ordering. Benefi t from: • cGMP-qualifi ed raw materials and processes, to help enable a seamless transition to larger cGMP volumes • Prototyping for bulk process liquids and buff ers in single-use bioprocess containers • Conversion of liquid and powder media to AGT media State-of-the-art bioproduction of small- to large-scale cGMP media Available in liquid, liquid concentrate, dry powder, and AGT format cGMP media manufacturing Customized media development to help optimize processes Our team of experts can develop a plan to help you achieve your goals Media development projects Rapid turnaround of small-scale prototypes Gibco rapid prototyping Catalog product evaluations and consultation Off -the-shelf solutions Ready to ship Services spotlight: Gibco Gibco to rapidly fi nalize your formulations before cGMP scale-up. With our responsive customer service and experienced production team, your custom medium can be shipped in as few as 10 days after ordering. Services spotlight: Gibco rapid prototyping services off er high-quality custom media to rapidly fi nalize your formulations before cGMP scale-up. With our responsive customer service and experienced production team, your custom medium can be shipped in as few as 10 days rapid prototyping services • Conversion of liquid and powder media to AGT media • cGMP-qualifi ed raw materials and processes, to help enable a seamless transition to larger cGMP volumes • Prototyping for bulk process liquids and buff ers in single-use rapid prototyping services off er high-quality custom media With our responsive customer service and experienced production Services spotlight: Gibco to rapidly fi nalize your formulations before cGMP scale-up. With our responsive customer service and experienced production team, your custom medium can be shipped in as few as 10 days rapid prototyping services Benefi t from: • cGMP-qualifi ed raw materials and processes, to help enable a • Prototyping for bulk process liquids and buff ers in single-use Services spotlight: Gibco team, your custom medium can be shipped in as few as 10 days rapid prototyping services • Conversion of liquid and powder media to AGT media seamless transition to larger cGMP volumes Rapid prototyping services: test and finalize formulation Feasibility Team conducts review of product feasibility and design for manufacturing Raw materials cGMP-qualified raw materials; novel raw materials by request Batch records Full batch record created Capacity Liquid media (1X) and liquid concentrate: 1–200 L Testing pH, osmolarity, sterility Packaging Standard bottles, Thermo Scientific™ BioProcess Containers (BPCs), custom packaging by request Delivery For standard orders of liquid media and liquid concentrate: 2 weeks cGMP: Clinical- to commercial-scale production Team conducts full cGMP feasibility review on custom orders cGMP-qualified raw materials; novel raw materials by request Full batch record created Liquid: 10–10,000 L Standard and custom testing available Standard bottles, BPCs, custom packaging by request Liquid: 8 weeks New Cat. No.: 10 weeks Technology transfer 16 thermofisher.com/gibco-cell-therapy Start your manufacturing journey with the end in mind As you progress your cell therapy to commercialization, scalability and security of supply are essential. We are committed to reinforcing our manufacturing network to help give you confidence when scaling up. We also offer a range of scale-up and scale-out solutions spanning the entire cell therapy development process, from cGMP-manufactured custom media to cell culture bags, for a complete expansion solution. Our pioneering end-to-end products, process development, and customization services can help maximize productivity while reducing costs and time-to-market. From R&D to large-scale manufacturing, our dedicated team of experienced scientists and regulatory professionals will help keep you at the forefront of the evolving cell therapy industry. Product Quantity Cat. No. CTS DynaMag Magnet 1 instrument 12102 CTS DynaCellect Magnetic Separation System • SmartStart Orientation at installation • Two-year warranty with planned maintenance (PM) in second year 1 instrument A55867 CTS DynaCellect Magnetic Separation System • SmartStart Orientation at installation • IQ/OQ at installation • Two-year AB qualification with OQ post-PM and/or repair 1 instrument A55868 CTS DynaCellect Cell Isolation Kit 5 pack A52300 CTS DynaCellect Bead Removal Kit 5 pack A52301 Cell therapy instruments Product Size Cat. No. CTS Dynabeads CD3/CD28 10 mL 40203D CTS Dynabeads Treg Xpander 10 mL 46000D Dynabeads Human T-Expander CD3/CD28 (RUO) 10 mL 11141D Dynabeads magnetic beads products Product Size Cat. No. CTS OpTmizer T-Cell Expansion SFM, no phenol red, bottle format 1 L A3705001 CTS OpTmizer T-Cell Expansion SFM, no phenol red, bag format 1 L A3705003 CTS OpTmizer Pro SFM, bottle format 1 L A4966101 CTS OpTmizer Pro SFM, bag format 1 L A4966103 CTS OpTmizer products Ordering information For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. Caution: Not intended for direct administration into humans or animals. © 2023 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. G-Rex is a trademark of Wilson Wolf Corporation. EXT4599 0323 Learn more about optimizing cell therapy development at thermofisher.com/gibco-cell-therapy