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Insights

Perspectives on cell therapy access

Thought leadership, whitepapers, and news from the Nalmera team — exploring the science, policy, and infrastructure behind making advanced therapies globally accessible.

ArticleFeatured

Controlling the Cost of Cell Therapy Manufacturing: Why a Sub-$100K Cell Therapy Is Possible

Cell therapy does not have to remain a $400,000–$600,000 product forever. A sub-$100K cell therapy is achievable — but not by asking suppliers to do it cheaper. It requires a different manufacturing and pricing philosophy: process simplification, closed workflows, labour designed around flow, integrated QC, and a business model built for access rather than premium pricing.

10 min read
ManufacturingCostAccessCAR-T
Article

The Hidden Cost of Open Processing in Cell Therapy

In cell therapy manufacturing, cost-of-goods discussions focus on materials — but the most underestimated driver is the open-process tax. Every open step triggers operator time, BSC occupancy, environmental monitoring, QA review, and deviation risk. In autologous therapy, where every patient is a batch, this tax multiplies. Closing the process is not only a sterility strategy — it is a cost, capacity, and throughput strategy.

ManufacturingGMPCost
6 min read
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Article

When Consultants Make Sense: Converting Fixed Cost into Operational Capability

As cell and gene therapy organisations move toward late-stage clinical or commercial operations, their needs change faster than their structures. Consultants make the most sense when used to accelerate capability while protecting against unnecessary fixed cost — particularly for transformation activities that are important but temporary: manufacturing readiness, throughput improvement, technology transfer, and commercial preparation.

OperationsStrategyManufacturing
12 min read
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Cell Therapy Implementation: A Global Perspective
Video

Cell Therapy Implementation: A Global Perspective

An in-depth discussion on the challenges and opportunities in bringing advanced cell therapies to patients worldwide — covering manufacturing, regulatory pathways, and health system readiness.

CAR-TAccessManufacturing
Video
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Whitepaper

Decentralised CAR-T Manufacturing: A Framework for Emerging Markets

Current CAR-T manufacturing models concentrate production in a handful of facilities in North America and Europe. This paper outlines a decentralised framework that enables regional GMP-compliant manufacturing hubs — reducing vein-to-vein time, lowering logistics costs, and expanding patient access across Latin America, Southeast Asia, and Sub-Saharan Africa.

ManufacturingAccessCAR-T
12 min read
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Article

Why Health Ministries Are the Missing Link in Cell Therapy Scale-Up

The bottleneck in global cell therapy access is rarely scientific. It is regulatory, reimbursement, and infrastructure readiness. We examine how proactive government engagement — from national registry development to public-private manufacturing partnerships — can compress the timeline from approval to patient access by years.

PolicyGovernmentAccess
8 min read
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News

Nalmera Expands Advisory Network Across Latin America

Nalmera has formalised advisory relationships with leading academic medical centres in Brazil, Mexico, Colombia, and Argentina. These partnerships will support feasibility assessments, regulatory pathway mapping, and the co-development of locally adapted cell therapy implementation programmes.

Company NewsLatin America
4 min read
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Article

The True Cost of Delayed Access: A Health Economics Perspective

For every year that a curative cell therapy remains inaccessible in a given market, the cumulative burden — measured in lives lost, disease progression, and downstream healthcare costs — is substantial. This analysis quantifies the economic and humanitarian case for accelerated implementation programmes in middle-income countries.

Health EconomicsAccessPolicy
10 min read
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Whitepaper

Technology Transfer in Advanced Therapies: Lessons from the First Decade

The transfer of cell and gene therapy manufacturing processes from originator to regional partner is one of the most complex undertakings in modern biopharmaceutical operations. Drawing on direct experience with Kymriah and subsequent programmes, this paper identifies the critical success factors and common failure modes in ATMP technology transfer.

ManufacturingTechnology TransferGMP
15 min read
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News

Nalmera Presents at EBMT Annual Meeting 2026

Co-founder Prof. Alejandro Madrigal presented Nalmera's implementation framework at the European Bone Marrow Transplantation Annual Meeting in Vienna, drawing significant interest from transplant centres exploring pathways to introduce CAR-T programmes in resource-constrained settings.

Company NewsEventsEBMT
3 min read
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Article

Simplicity Wins: How Lean Principles and Smart Automation Can Reshape Pharma Manufacturing

In pharma and advanced therapy manufacturing, the organisations truly outperforming their peers share one defining trait: a ruthless commitment to simplicity. Lean thinking removes non-value-added steps, streamlines flow, and builds quality into the process. Smart automation amplifies this — but only when applied to stable, simplified foundations. Complexity breeds confusion; simplicity provides the momentum.

ManufacturingLeanAutomation
8 min read
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Paper

Barriers and Facilitators to CAR-T Cell Therapy Access in Low- and Middle-Income Countries

A systematic analysis published in Cytotherapy examining the structural, regulatory, and economic barriers preventing equitable access to CAR-T therapies in LMICs — alongside evidence-based facilitators that could accelerate implementation. Essential reading for health systems, funders, and policy makers working to close the global cell therapy gap.

AccessPolicyCAR-TResearch
15 min read
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Article

Get Into My CAR-T

CAR-T cell therapy has transformed outcomes for patients with relapsed or refractory blood cancers — but the manufacturing and logistics complexity behind each infusion remains formidable. This feature examines what it actually takes to get a CAR-T product from leukapheresis to patient, and where the field is heading as it scales.

CAR-TManufacturingAccess
8 min read
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