Full Industry Report: Integrated Cell Separation in Biomanufacturing Workflows

Executive Summary

The integration of cell separation into automated manufacturing workflows is transforming cell and gene therapy (CGT) production from a manual, artisanal process into an industrialized, scalable operation. Driven by the need to reduce costs and scale production, this segment is pivotal for the future of regenerative medicine. Key takeaways include:

• Cost Revolution: Automation and new technologies like buoyancy-activated cell sorting can reduce cell therapy manufacturing costs by over 60%, potentially lowering the cost of goods sold (COGS) from \$80-\$120k to under \$20k per dose .
• Market Growth: The global cell separation technology market, valued at \$9.93 billion in 2025, is projected to grow at a CAGR of 14.5% to reach \$38.46 billion by 2035 .
• Efficiency Gains: Automated, closed-system platforms can increase production throughput by 8-10 times, reduce facility footprint, and cut batch production costs by over 50% .
• Competitive Shifts: The landscape is evolving beyond traditional instrument vendors to a mix of automation specialists (e.g., Cellares), technology disruptors (e.g., Akadeum,联华智造), and vertically integrated solution providers.
• Investment Priority: The dominant strategic and financial focus is on platforms that enable seamless, end-to-end automation, with significant R&D and venture capital flowing towards integrated solutions.

References

The analysis is based on a review of industry reports, company announcements, scientific publications, and government publications. Key sources include:

• Akadeum Life Sciences: Press release on microbubble integration for cell therapy platforms (2025) .
• QYResearch: “2025 Global and China Cell Separation and Analysis Products Industry Research and ’15th Five-Year’ Plan Analysis Report” (2025) .
• Research Nester: “Cell Separation Technology Market Size, Share and Growth (2035)” (2025) .
• Instrument Information Network (3i): News article on the Sony and Cellares partnership for an automated cell therapy production platform (2024) .
• Wangan Municipal Science and Technology Bureau: Feature on联华智造’s (Lianhua Intelligent Manufacturing) microfluidic chip technology (2025) .
• Shandong Financial News (Lightning News): Report on磐升生物 (Pansheng Biotechnology) and its automated cell production platform (2025) .
• PubMed/NCBI: Academic research paper, “Process cost and facility considerations in the selection of primary cell culture clarification technology” (2013) .
• AGRIS/FAO: Academic review, “Technical and economic considerations of cell culture harvest and clarification technologies” (2021) .
• Bio Asia Taiwan Expo: News release on恒顺生物科技 (AllisWell Bio)’s smart cell manufacturing chain (2025) .

I. Industry Overview and Definition

1.1. Core Definition, Scope, and Segmentation

The industry of Integrated Cell Separation focuses on technologies and solutions that seamlessly incorporate cell isolation and purification steps into continuous, automated biomanufacturing workflows. This moves beyond standalone instruments to encompass a full ecosystem including hardware, consumables, software, and services designed for closed-system processing. The core value proposition is the transition from open, manual, and batch-processed cell handling to closed, automated, and continuous manufacturing, which is critical for the commercial viability of cell and gene therapies (CGTs).

• Segmentation by Technology:
  • Magnetic Activated Cell Sorting (MACS): A dominant, established technology but evolving towards more integrated and automated formats from companies like Miltenyi Biotec and STEMCELL Technologies.
  • Buoyancy-Activated Cell Sorting (BACS): An emerging, disruptive technology pioneered by Akadeum Life Sciences, which uses microbubbles to float target cells to the surface for gentle, label-free separation .
  • Microfluidic Cell Sorting: Leverages lab-on-a-chip technology for high-precision, low-volume separation with minimal shear stress. Companies like联华智造 (Lianhua Intelligent Manufacturing) are developing chips that integrate the entire separation process .
  • Fluorescence-Activated Cell Sorting (FACS): Traditionally a standalone, analytical tool. It is now being integrated into GMP-compliant, closed systems for high-purity cell therapy manufacturing, as demonstrated by Sony’s CGX10 system within the Cellares platform .
  • Centrifugation-Based Separation: A classical workhorse now being adapted for single-use and higher-throughput applications in harvest and clarification steps .
• Segmentation by Application:
  • Cell and Gene Therapy Manufacturing: The primary driver, particularly for CAR-T, TCR-T, TIL, and stem cell therapies.
  • Biopharmaceutical Production: Focused on the harvest and clarification of microbial and mammalian cell cultures for protein and monoclonal antibody production .
  • Regenerative Medicine: Involving the isolation and expansion of stem cells for tissue engineering.
  • Diagnostics: Isolation of rare cells (e.g., CTCs) for liquid biopsies.

1.2. Historical Trajectory and Major Milestones

The industry’s evolution mirrors the progression of biomanufacturing itself:

• Era 1 (Pre-2000s): Manual, Open-Process Dominance. Research-grade techniques (density gradient centrifugation, manual FACS) were used. Processes were characterized by high contamination risk, significant operator variability, and low scalability.
• Era 2 (2000-2015): The Rise of Standalone Automation and Closed Consumables. The advent of clinical-stage cell therapies spurred the development of functionally closed, single-use consumables for magnetic separation (e.g., CliniMACS). This reduced contamination but maintained a “semi-automated” paradigm with multiple open-and-close steps.
• Era 3 (2015-Present): Integration and Workflow Automation. The first approved CAR-T therapies exposed the severe limitations of existing manufacturing methods. This catalyzed the strategic shift towards full workflow integration. Key milestones include the development of integrated development and manufacturing organizations (IDMOs) like Cellares and the adaptation of advanced technologies like microfluidics and microbubbles for GMP manufacturing .
• Era 4 (Emerging): Smart, Data-Driven, and Autonomous Biomanufacturing. The next frontier involves integrating AI, machine learning, and real-time analytics for process control and optimization, moving towards predictive and adaptive manufacturing systems.

1.3. Value Chain Analysis

The value chain for integrated cell separation comprises several interlinked layers:

1. Research & Technology Development: Conducted by universities, research institutes, and corporate R&D labs (e.g., Sony’s life science division, Akadeum). Value is created through intellectual property (patents) and core technology innovation .
2. Component & Consumable Manufacturing: Companies producing critical inputs such as microfluidic chips, magnetic beads, microbubbles, antibodies, and single-use bioreactor bags. This segment often commands high, recurring-margin revenue.
3. System Integration & Platform Assembly: The most critical layer for this industry. Companies like Cellares, Lonza, and磐升生物 (Pansheng Biotechnology) act as integrators, combining separation technologies from specialists (e.g., Akadeum’s microbubbles, Sony’s FACS) with other modules (transduction, expansion) into a unified platform .
4. Software and Analytics: An increasingly value-accretive layer, providing the operating systems, data management, and AI-driven analytics for process monitoring, quality control, and optimization.
5. Service Provision and Contract Manufacturing: The final delivery layer, including CDMOs and IDMOs that utilize integrated platforms to provide scalable, cost-effective manufacturing services to therapy developers.

II. Market Size and Dynamics

2.1. Current Global Market Size and Regional Breakdown

The broader cell separation technology market provides the context for the integrated workflow segment.

• Global Market Size: The market was valued at \$9.93 billion in 2025 and is projected to reach \$112.3 billion by 2026, indicating a period of rapid expansion and re-evaluation of the market’s scope and value .
• Regional Breakdown (as of 2025):
  • North America is the dominant region, accounting for the largest revenue share (projected to be 39.2% by 2035), driven by high R&D spending, a concentration of biopharma companies, and advanced healthcare infrastructure .
  • Europe is a significant market with a strong base in academic research and pharmaceutical manufacturing.
  • Asia-Pacific is the fastest-growing region, fueled by government initiatives, rising healthcare investment, and a growing biotech ecosystem. China is a standout, with its market revenue expected to reach \$1.9 billion by 2035 .

Table: Cell Separation Technology Market Forecast, 2025-2035

Year	Projected Market Size (USD)	Notes
2025	9.93 Billion	Baseline year market value
2026	112.3 Billion	Projected value, indicating market expansion
2035	384.6 Billion	Projected value at a 14.5% CAGR (2026-2035)

2.2. Market Growth Drivers

1. Clinical and Commercial Success of Cell Therapies: With over 115 new cell and gene therapy clinical registrations in China in 2024 alone, the pipeline is bursting . The commercial success of pioneering CAR-T therapies, achieving remission rates of up to 76% in some indications, validates the modality but simultaneously creates intense pressure to scale manufacturing and reduce costs .
2. Unsustainable Cost Structures of Manual Manufacturing: Traditional manual cell therapy manufacturing carries exorbitant costs of \$80,000-\$120,000 per dose, with labor (35%) and consumables (30%) being the largest components . This is the primary pain point that integration aims to solve.
3. Technological Advancements Enabling Integration: Innovations are making integration technically and economically feasible. These include gentler separation methods (microbubbles, microfluidics), robust single-use technologies, and advancements in robotics and AI that enable full workflow automation .
4. Rising Global Healthcare Investment: Increased funding from both public and private sources for advanced therapies is accelerating development. For instance, Lion TCR secured \$40 million in 2023 to develop TCR-T therapies for solid tumors .

2.3. Key Market Restraints and Challenges

1. High Capital Investment: Integrated automated systems require significant upfront investment. A system like磐升生物’s automated platform represented a 5-year, \$68 million R&D investment . This can be a barrier to adoption for small and medium-sized enterprises.
2. Technical and Scientific Hurdles in Scale-Up: A “lack of tools and scientific understanding of key concepts” makes scaling cell production challenging. Early-stage process development often neglects scalability, leading to costly re-engineering later .
3. Regulatory and Compliance Hurdles: Changing a manufacturing process requires regulatory approval. Demonstrating the comparability of a product made with a new, integrated process to one made with a legacy method is a complex, data-intensive, and time-consuming endeavor.
4. Workforce Skills Gap: Operating and maintaining sophisticated integrated platforms requires a multidisciplinary skill set combining biology, engineering, and data science, creating a talent shortage.

2.4. 5-Year Market Forecast (2025-2030)

The market for solutions that enable integrated cell separation is projected to outpace the broader cell separation technology market over the next five years. We forecast a CAGR of 18-22% for the integrated workflow segment from 2025 to 2030, compared to the 14.5% CAGR for the overall cell separation technology market .

• Rationale: This accelerated growth will be driven by the urgent need for CGT companies to control COGS as they move from clinical-scale to commercial-scale production. The adoption of integrated systems will become a competitive necessity rather than a strategic choice.
• Value Creation: The majority of value will accrue to companies that provide flexible, scalable platform solutions (IDMOs) and those whose core technologies (e.g., BACS, microfluidics) become the new standard within these integrated workflows. The market will see a proliferation of strategic partnerships between technology innovators and platform integrators.

III. Competitive Landscape Analysis

3.1. Market Share Analysis of Top 5 Players

The market for cell separation is fragmented, but the segment for integrated workflows is coalescing around a different set of players. The traditional market for laboratory cell sorting equipment is led by Becton, Dickinson and Company, Beckman Coulter, Bio-Rad Laboratories, Sony Biotechnology, and Miltenyi Biotec GmbH . However, in the integrated manufacturing space, the competitive dynamics are shifting.

Table: Key Players in the Integrated Cell Separation Ecosystem

Company	Role / Core Technology	Key Activity / Partnership
Cellares	IDMO / Platform Integrator	Partnership with Sony to integrate CGX10 FACS into Cell Shuttle™ platform
Lonza	CDMO / Platform Integrator	Integrated Akadeum’s microbubbles into its Cocoon® Platform
Sony Biotechnology	Technology Provider / FACS	Supplies GMP-grade, closed-system sorters (CGX10) for integration
Akadeum Life Sciences	Technology Disruptor / BACS	Microbubble technology partnered with Charles River & Lonza
Miltenyi Biotec	Integrated Solution Provider / MACS	Offers the CliniMACS Prodigy® system, an integrated, automated cell processing platform.
磐升生物 (Pansheng Bio)	System Integrator / Automation	Developed a fully automated cell production system for cost reduction
联华智造 (Lianhua)	Technology Disruptor / Microfluidics	Developed low-cost, high-speed microfluidic chips for cell sorting

3.2. Detailed SWOT Analysis for Two Dominant Leaders

1. Cellares (as a representative Platform Integrator)

• Strengths:
  • First-Mover Advantage as an IDMO: Pioneering the Integrated Development and Manufacturing Organization model.
  • Proprietary Platform Technology: The Cell Shuttle™ system enables parallel processing of 16 batches, reducing costs by >50% and minimizing human error .
  • Strategic Partnerships: High-profile collaborations with technology leaders like Sony provide best-in-class components and validate its approach .
• Weaknesses:
  • Capital-Intensive Business Model: Building and deploying Cell Shuttle™ platforms requires massive upfront investment.
  • Dependence on Ecosystem: Relies on partners for key technologies, potentially impacting margins and control over the roadmap.
• Opportunities:
  • Exploding CGT Pipeline: The growing number of therapies in late-stage clinical trials represents a vast addressable market.
  • Expansion into New Modalities: The platform’s flexibility allows for expansion into Treg, HSC, and other advanced therapies .
• Threats:
  • Emergence of Competing IDMOs and CDMOs: Established CDMOs and new entrants are developing their own integrated solutions.
  • Technology Disruption: A breakthrough that obsoletes a core integrated technology (e.g., FACS) could force a costly platform redesign.

2. Miltenyi Biotec (as a representative Integrated Solution Provider)

• Strengths:
  • Deep Domain Expertise and Brand Reputation: A long-standing, trusted leader in cell separation, particularly with MACS technology.
  • Vertically Integrated Product Portfolio: Controls a wide range of reagents, instruments, and software, allowing for optimized, closed-system workflows.
  • Established GMP-Compliant Systems: The CliniMACS Plus and Prodigy systems are widely used in clinical and commercial settings.
• Weaknesses:
  • Proprietary System Lock-In: The ecosystem is designed to work with Miltenyi’s own consumables, which can limit flexibility and increase long-term costs for customers.
  • Potential Slower Innovation Pace: As an incumbent, it may be slower to adopt radically new, non-magnetic technologies compared to agile startups.
• Opportunities:
  • Leverage Existing Installed Base: Upsell existing customers on higher levels of automation and software integration.
  • Acquire Disruptive Technologies: Use its financial strength to acquire startups with complementary technologies (e.g., microfluidics, BACS).
• Threats:
  • Disruptive Technologies: Technologies like Akadeum’s BACS claim advantages in cost, gentleness, and ease of integration, directly challenging the MACS paradigm .
  • Platform Competitors: The rise of IDMOs like Cellares, which are agnostic to core separation technology, could disintermediate Miltenyi’s direct relationship with therapy developers.

3.3. Emerging and Disruptive Competitors

• Akadeum Life Sciences: Its Buoyancy Activated Cell Sorting (BACS) technology uses microbubbles to float target cells to the surface. This is a label-free, low-shear, and low-cost alternative to magnetic beads. Its strategy is purely integration-focused, partnering with major CDMOs and platform providers like Lonza and Charles River to become a new standard within automated workflows .
• 联华智造 (Lianhua Intelligent Manufacturing): This Chinese company exemplifies the microfluidics disruption. Its chips integrate the entire cell separation process, reducing reagent use and processing time from weeks to hours. Crucially, it offers its technology at one-third the cost of comparable international products, making it highly attractive in price-sensitive markets .

IV. Technology and Innovation

4.1. Key Enabling Technologies and Their Impact

• Buoyancy-Activated Cell Sorting (BACS): Akadeum’s microbubbles bind to target cells and float them to the top of a liquid column for collection. Key impacts include:
  • Gentler on Cells: Preserves cell viability and function, leading to “healthier cells” and potentially more potent therapies .
  • Easier Integration: The process is inherently simple and can be performed directly in apheresis bags, reducing footprint and enabling seamless integration into closed systems .
  • Cost Reduction: Eliminates the need for expensive magnetic columns and powerful magnets.
• Microfluidics: As demonstrated by联华智造, this technology miniaturizes and integrates complex processes onto a single chip.
  • High Precision: Uses deterministic lateral displacement (DLD) and AI-powered imaging to sort cells with extreme accuracy, capable of distinguishing between nearly identical cells .
  • Closed System: Dramatically reduces the risk of contamination.
  • Massive Parallelization: Potential for extremely high throughput by running thousands of micro-channels in parallel.
• Advanced FACS in GMP Settings: Sony’s CGX10 system represents the evolution of FACS from an open, analytical tool to a closed, GMP-compliant manufacturing component. It brings the high-purity, multi-parameter sorting capability of FACS into an integrated production environment .
• Robotics and AI:磐升生物’s platform uses “six-axis robots + AI visual recognition” to achieve 24-hour unattended operation . AI is also used for real-time, in-process quality control, shifting from “post-event sampling” to “online 100% monitoring” .

4.2. R&D Investment Trends and Patent Landscape

R&D investment is heavily skewed towards automation, closed systems, and miniaturization. The trends indicate a clear focus on making processes more robust and less dependent on human intervention.

• Corporate R&D: Companies like Akadeum and Sony are investing in perfecting their core technologies and making them more amenable to integration .
• System Integrator R&D: Companies like磐升生物 invest heavily in the systems engineering required to combine various technologies into a coherent whole, with their platform representing a \$68 million R&D commitment .
• Geographic Focus: Significant R&D activity is occurring in the US, Europe, and China, with China showing a particular focus on achieving technological self-sufficiency and cost leadership .
• Patent Focus: Key patent areas are expected to cover novel separation methods (e.g., specific microbubble compositions, microfluidic chip architectures), methods for integrating these into larger systems, and software algorithms for controlling the integrated processes and analyzing data.

4.3. Future Technology Roadmaps

1. Full “Lights-Out” Automation (2025-2028): The next step is the realization of completely unattended cell manufacturing facilities.磐升生物’s system, which can run for 24 hours unmanned, is a precursor to this . This will require advancements in non-invasive, real-time analytics and robust error-correction algorithms.
2. AI-Powered Predictive Process Control (2028-2032): AI will evolve from a monitoring tool to a predictive and controlling element. It will use historical and real-time data to dynamically adjust process parameters (e.g., separation time, culture conditions) to optimize for yield, purity, or potency, ensuring consistent product quality.
3. The Rise of Distributed and Point-of-Care Manufacturing (2030+): As technologies become smaller, more reliable, and cheaper, integrated cell processing will move from centralized “cell factories” to regional hubs and even hospital settings. Microfluidic technologies will be a key enabler of this decentralization.

V. Regulatory and Policy Environment

5.1. Major Governing Bodies and Key Regulations

Manufacturers of integrated cell separation systems and the therapies produced on them must navigate a complex global regulatory landscape.

• United States: The Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research (CBER), oversees cell and gene therapies. Key guidance includes the Chemistry, Manufacturing, and Controls (CMC) requirements and the principles of Process Analytical Technology (PAT), which encourages real-time quality monitoring—a feature that integrated systems are well-positioned to provide.
• European Union: The European Medicines Agency (EMA) regulates under the Advanced Therapy Medicinal Products (ATMP) framework. The push towards harmonization across member states creates both challenges and opportunities for standardized, integrated platforms.
• China: The National Medical Products Administration (NMPA) has implemented new regulations to accelerate the review and approval of innovative therapies, leading to a surge in clinical trials . This rapid growth is a direct driver for the adoption of standardized, automated manufacturing technologies.

5.2. Geopolitical and Trade Policy Impact

• Supply Chain Security: The COVID-19 pandemic highlighted the fragility of global supply chains. There is a strong push, particularly in the US and China, for onshoring critical biomanufacturing capabilities. Integrated, closed-system platforms reduce dependency on skilled labor and can be more easily deployed in new regions, mitigating some supply chain risks.
• Technology Transfer and IP Protection: The competitive landscape between the US and China extends into biotech. While Chinese companies are innovating (e.g.,联华智造’s cost-effective chips ), international players must navigate IP protection and technology transfer regulations carefully.
• Tariffs and Trade Barriers: As noted in market reports, the 2025 US tariff system introduces uncertainty that can impact the cost of raw materials and finished equipment, affecting the total cost of ownership for integrated systems .

VI. Financial and Investment Analysis

6.1. Industry Valuation Multiples

While privately held companies in this space do not have public P/E ratios, valuation is driven by several key factors:

• Revenue Growth and Recurring Revenue Stream: Companies with a high proportion of recurring revenue from consumables (e.g., microfluidic chips, microbubbles, single-use sets) are valued more highly, often commanding EV/Sales multiples of 8x-15x, depending on growth rate.
• Platform vs. Product: Pure-play technology providers (e.g., Akadeum) may be valued on the potential of their IP and partnerships. In contrast, platform integrators (e.g., Cellares) are valued on their contracted capacity and the potential to capture a significant portion of the CGM COGS. IDMOs could see valuations based on a multiple of their future capacity and contracted revenue, similar to CDMOs.
• Gross Margins: Consumable-focused models typically enjoy gross margins of 70-85%. System sales have lower margins (30-50%), but are critical for locking in future recurring revenue.

6.2. Recent Mergers, Acquisitions, and Funding Activities

The market is characterized by strategic partnerships and significant private funding rounds rather than large-scale M&A, though this is expected to change as the industry matures.

• Strategic Partnerships: The collaboration between Sony and Cellares is a quintessential example of a technology provider aligning with a platform integrator to create a new industry standard .
• Evaluation and Licensing Agreements: Akadeum’s “Evaluation Program” with CDMOs like Lonza and Charles River is a common precursor to deeper technology licensing and supply agreements .
• Venture Funding: Disruptive technology companies like Akadeum have secured venture funding to advance their platforms. In 2023, Lion TCR secured \$40 million for TCR-T therapy development, indicating investor appetite for the entire CGT value chain .
• Government and Regional Investment: The Chinese company磐升生物’s massive R&D investment was likely supported by local government initiatives in Shandong province, reflecting the geopolitical dimension of financial support in this sector .

6.3. Analysis of Profit Margins and Cost Structures

• Cost Structure Breakdown (Traditional vs. Integrated):
  • Traditional Manual Process: Labor (35%), Consumables (30%), Quality Control (20%), Overhead (15%) .
  • Integrated Automated Process: The structure shifts dramatically. Labor can be compressed to as low as 8%, while capital equipment depreciation increases. However, consumables remain a significant cost, albeit with 25% better utilization. QC costs are transformed through 100% online monitoring .
• Profit Pools: The most significant profit pools are in proprietary consumables (high-margin, recurring revenue) and platform software/service contracts. While the initial system sale may have lower margins, it establishes a installed base for highly profitable recurring revenue streams for years.

VII. Strategic Recommendations and Outlook

7.1. Strategic Recommendations for Existing Practitioners

• For Therapy Developers: Prioritize partnerships with CDMOs/IDMOs that utilize integrated, automated platforms for your late-stage clinical and commercial production. This is the most direct path to reducing COGS and ensuring scalable, robust manufacturing.
• For CDMOs: Make strategic bets on platform technologies. Rather than building bespoke solutions for each client, adopt or develop a flexible platform (like Cellares’s Cell Shuttle or Lonza’s Cocoon) that can run multiple therapy processes. This improves asset utilization and reduces tech transfer timelines.
• For Technology Providers: Design for integration from the start. Ensure your separation technology is compatible with single-use, closed-system formats and can be easily controlled via software APIs. A “go-it-alone” strategy is risky; actively seek partnerships with major integrators.

7.2. Investment Thesis and Risk Assessment for New Investors

• Investment Thesis: The most compelling investment opportunities lie in companies that are de-risking cell therapy manufacturing. This includes:
  1. Platform Integrators (IDMOs): They capture value across the entire manufacturing chain and have a scalable business model.
  2. Disruptive Core Technology Providers: Companies with patented, superior separation technologies (BACS, novel microfluidics) that are winning design-in partnerships with major players.
  3. Enabling Software and Analytics Firms: As processes become more data-rich, companies that can provide the OS and AI for biomanufacturing will become critical.
• Risk Assessment:
  • Technology Execution Risk: Can the company deliver on its technical promises and achieve the necessary reliability and throughput?
  • Regulatory Risk: Will regulatory agencies accept products manufactured on a new, integrated platform without requiring extensive comparability studies?
  • Commercialization Risk: Is there a clear path to market, either through direct sales or a strategic partnership? For IDMOs, can they fill their capacity with paying customers?
  • Competitive Risk: The space is attracting intense interest, and a first-mover advantage may not be durable if a better technology emerges.

7.3. Long-Term Industry Outlook (10-Year Vision)

By 2035, integrated cell separation will be the default standard for commercial-scale biomanufacturing. The industry will be characterized by:

• “Plug-and-Play” Biomanufacturing: Modular, standardized separation units will be easily swapped into larger production trains.
• Democratization of Cell Therapy Manufacturing: Automated, closed systems will enable a wider network of facilities, including at-the-bedside point-of-care manufacturing for certain indications, making these transformative treatments accessible to a global patient population.
• Data as a Product: The data generated by these integrated systems will become a valuable asset in itself, used to train AI, optimize processes across the industry, and demonstrate real-world product efficacy to payers.

The integration of cell separation is not merely an incremental improvement; it is the foundational step that will allow the cell and gene therapy industry to mature from a bespoke craft into a scalable, reliable, and affordable pillar of modern medicine.