POSTmark CAR-T: Delivering Therapies Without Delay

CAR-T therapies have redefined cancer treatment, moving from bold hypothesis to frontline standard in less than a decade. With more than 2,200 gene therapies, including CAR-T programs, in development worldwide, competition is fierce, and timelines are unforgiving.1 Yet progress is still slowed by a persistent barrier: manufacturing.¹ 

Unlike traditional biologics, CAR-T is inseparable from its process. Every variable (starting cell quality, activation method, viral transduction efficiency, expansion conditions) shapes the final product. For many developers, this makes tech transfer and scale-up a minefield, where even small changes trigger comparability issues, regulatory delays, or clinical holds. 

Lost in Transit: Why Manufacturing Is the Bottleneck

CAR-T is a living medicine. That reality makes its production highly sensitive:

• Patient-to-patient variability. Each autologous therapy begins with a unique set of T cells, introducing variability before any engineering begins.
• Complex, multi-step workflows. Cell enrichment, viral transduction, and expansion must be precisely orchestrated to maintain potency.
• High regulatory scrutiny. Agencies now expect full analytical packages earlier in development, including potency, persistence, and comparability data.

These constraints mean that many programs stumble not on science, but on manufacturing continuity. Moving from R&D to GMP can feel like starting over.

Figure 1. Complex and highly coordinated autologous CAR-T therapy manufacturing. Both autologous and allogeneic CAR-T (and other CAR immunotherapies like CAR-NK) manufacturing require a uniquely challenging process. (Source: Blache et al. Nature Communications. 2022)

An Integrated Platform: From Bench to GMP

Landmark Bio built its Platform Optimized for Scale-up and Transfer (POSTmark^™) to address exactly the pain point of manufacturing continuity. Available for CAR-T, AAV, and LVV manufacturing, the POSTmark process supports all stages of development from benchtop R&D to cGMP scale. 

Mirrored Environments

Establishing identical non-GMP and GMP systems. Mirrored process and analytical development includes the same equipment and processes that can be ported into an identical cGMP-compliant workstream. Developers can generate IND-enabling data in R&D, then port it directly into GMP without risking product comparability issues or delays.

Embedded Expertise

In-house expertise and guidance. Each program is supported by a dedicated technical lead and a program manager. These experts don’t just oversee the work, they integrate into the client’s team, ensuring every decision is biologically informed and clinically relevant

Tailored Development Pathways

POSTmark is modular and flexible. Whether advancing an autologous CAR-T, an allogeneic platform, or a mixed-modality approach, the framework adapts, supporting everything from proof-of-concept studies to full clinical supply.

Regulatory Alignment

IND-ready in 9-12 months. Because POSTmark minimizes process changes between preclinical and clinical phases, it helps developers build IND-ready packages with fewer surprises and a stronger case for regulatory reviewers.

Streamlining CAR-T in Practice

• Enrichment. Patient cells processed on Rotea and CliniMACS Plus systems for subset selection.
• Activation & Transduction. CAR lentiviral vectors introduced into activated T cells under mirrored conditions.
• Expansion. Autologous cells expanded in G-Rex vessels; allogeneic in Xuri systems.
• Formulation & Fill. GMP-compliant filling into bags or vials.
• Integrated QC. Identity, potency, purity, and persistence assays conducted in-house

Every step is standardized under the POSTmark philosophy, ensuring continuity from early research runs to clinical-grade production.

Figure 2. Landmark Bio's CAR-T workflow reduces time and costs risks through an end-to-end process. For autologous CAR-T, Landmark Bio's workflow is just 7 days from receipt to QC with both cell therapy and lentiviral manufacturing in a single facility. 

Table 1. Landmark Bio's CAR-T analytics capabilities.

One Roof, One Process: Lentiviral & CAR-T Manufacturing

A critical but often overlooked aspect of CAR-T development is the tight coupling between lentiviral vector (LVV) manufacturing and cell therapy production. Most CAR-T constructs rely on LVVs for stable gene transfer, requiring carefully coordinated timelines between vector and CAR-T manufacturing.   

When LVV and cell therapy manufacturing occur at separate sites, dependencies around scheduling, batch release, and shipping between two vendors can jeopardize manufacturing timelines if the LVV drug substance isn’t received on schedule. 

Landmark Bio eliminates this disconnect. By hosting both LVV and CAR-T manufacturing within a single modular facility, we enable: 

• Tighter scheduling control: In-house coordination of vector production, T-cell transduction, and expansion reduces logistical complexity and preserves critical timelines. 
• Streamlined regulatory and quality oversight: Both LVV and CAR-T workflows run under the same quality system, simplifying oversight and release coordination. 
• Faster path to IND: With viral vector and CAR-T workflows running together, developers can progress from plasmid design to filled CAR-T product without external bottlenecks. 

Figure 3. Viral vector and autologous CAR-T cell therapy bioprocessing. Manufacturing capabilities for both modalities ensures seamless continuity between viral vector and cell therapy manufacturing stages. (Source: Labbe et al. Viruses. 2021.)

The robust 3rd-generation LVV platform includes scalable (50–200 L) HEK293 suspension systems, followed by two-stage chromatography with integrated analytical workflows to meet your clinical needs. 

Table 2. Landmark Bio's lentiviral analytics capabilities set programs up for regulatory success and rapid clinical entry.  

Why It All Matters in Today’s Landscape

The industry has reached a tipping point:

• CAR-T dominates the modified cell therapy pipeline (55%)
• 83% of programs are oncology-focused, but autoimmune and solid tumor indications are expanding rapidly
• Investors are pushing timelines shorter than ever, while regulatory expectations rise.

In this environment, the old paradigm of rebuilding processes at GMP no longer works. POSTmark provides a direct bridge, eliminating the disconnect between discovery and clinic.

Figure 4. CAR-Ts continue to dominate the gene therapy breakdown. (Source: Gene, Cell, & RNA Therapy Landscape Report Q2 2025)

Hitting the Ground Running: A Case Study

Other CDMOs can manufacture CAR-T. Landmark Bio makes it manufacturable without compromising speed or science. That difference comes down to POSTmark:

• Continuity. No wasted time or data between R&D and GMP.
• Collaboration. Teams of drug developers, not just service providers.
• Flexibility. Capability to support autologous, allogeneic, and novel modalities in the same facility.
• Confidence. IND-enabling data packages generated with downstream GMP requirements in mind.
  

Figure 5. A Landmark Bio client experienced what's possible when expertise meets agility to accelerate their CAR-T program. For one biotech partner, we initiated custom tech transfer for their unique cell therapy platform in just 2 weeks, completed the first engineering run in 3 months, and have since produced 45+ GMP lots. (A more detailed case study for this particular program is in the works... coming soon.)

The Future of CAR-T, Addressed Today

CAR-T therapies are rewriting oncology and opening doors in autoimmunity and beyond. But the future of the field depends as much on process as on biology.

Landmark Bio’s POSTmark platform makes manufacturing an asset, not a bottleneck, bridging innovation and GMP with mirrored environments, embedded expertise, regulatory foresight, and uniquely flexible partnership models.

For innovators, this means one thing: the confidence that your first shot will be your best shot.

Learn more about our cell therapy capabilities and connect with Landmark Bio to learn how POSTmark can accelerate your CAR-T program: 

¹ Gene, Cell, & RNA Therapy Landscape Report Q2 2025)