Inside the CAR-T Patient Journey: Volume 2
Who We Are - and Why Policy Matters
In Volume 1, we explored the science behind CAR-T therapy - how a patient’s own immune cells are collected, genetically modified to recognise cancer, and returned to the patient as a personalised treatment.
But CAR-T therapy does not move from science to patient care on its own. Between cell collection and treatment delivery sits a complex, highly regulated manufacturing journey, involving specialist facilities, trained personnel, and strict quality controls. This is where BioOra sits - and where policy decisions begin to matter in very real ways for patients.
Who is BioOra, and what role do we play in the CAR-T patient journey?
We are New Zealand’s first CAR T-cell manufacturing company, established to deliver cell therapy for every patient in need. We do this by combining scientific innovation with advanced, semi-automated manufacturing to produce CAR-T therapies safely and efficiently.
Our manufacturing follows GMP (Good Manufacturing Practice), the internationally recognised standard for medicines that ensures consistent quality and patient safety. This approach allows us to deliver personalised therapies faster, more reliably, and at lower cost.
We are currently manufacturing CAR-T therapies for a Phase II clinical trial, while advancing toward scalable commercial production. Our focus is not only scientific innovation, but the automation and scaling of CAR-T manufacturing to improve reliability, reduce turnaround times, and strengthen long-term access to these therapies.
In the CAR-T journey, our role begins once a patient’s cells are collected. Under tightly controlled GMP conditions, we transform those cells into a personalised therapy that can be safely returned to clinics for treatment.
Unlike conventional medicines, CAR-T therapies are made for individual patients. Quality, traceability, and consistency are therefore not abstract regulatory requirements, they directly affect whether a patient receives their treatment on time, or at all.
Why do manufacturing excellence and proximity matter to patients?
CAR-T therapies are both personalised and time-critical. Cells must be collected, processed, tested, and returned within defined timeframes. Delays or failures at any stage can have serious consequences for patients whose disease does not pause while CAR-T is made.
Local manufacturing adds many benefits: proximity to patients and clinicians shortens turnaround times, reduces logistical complexity and cost, and allows closer coordination with treating teams. Manufacturing excellence, meanwhile, ensures every therapy meets rigorous qaulity and safety standards.
If a country has limited capacity to manufacture CAR-T therapies at scale and needs to rely on overseas facilities for this task, shipping cells internationally may contribute to longer transport times, added logistical complexity, and higher costs. By producing CAR-T therapies in New Zealand, we can deliver treatment faster, and with improved reliability and affordability, which in turn directly benefits patients.
As more personalised therapies move from early adoption into broader clinical use, manufacturing capacity itself becomes a determinant of patient access.
Why is the Gene Technology Bill relevant to delivering CAR-T therapy in New Zealand?
The existing Hazardous Substances and New Organisms (HSNO) Act 1996 was created well before personalised cell and gene therapies became a clinical reality, and was primarily designed for agricultural and environmental applications - not patient-specific medical treatments. For organisations like BioOra, operation under rules that weren’t designed for therapies can slow innovation, create unnecessary costs, and limit patient access.
The Gene Technology Bill introduces a modern, proportionate framework for our therapies. It recognises the medically regulated, patient-specific nature of therapies like CAR-T and aligns New Zealand’s approach with international best practice.
For a patient-focused organisation, regulation should protect patient safety while supporting broad access to care. At BioOra, this means the Bill provides a regulatory environment that is fit for the realities of developing, manufacturing, and delivering personalised therapies. Clear, modern regulation ensures that we can operate and plan for the future without unnecessary barriers.
Why policy matters when patients are waiting
Policy settings can feel abstract when viewed from a distance. In practice, they translate into real operational requirements within a CAR-T manufacturing environment.
Regulatory clarity affects how facilities are built or expanded, how staff are trained, and how quickly new therapies can be adopted. Over time, these decisions influence our ability to deliver advanced therapies efficiently and reliably within New Zealand.
Clear, fit-for-purpose regulations also allow us to:
scale manufacturing without compromising quality
Maintain robust safety and traceability standards
Adapt processes to evolving clinical needs
BioOra proactively evaluates emerging policy changes to ensure our manufacturing capability, regulatory strategy, and supply model remain fit for purpose, so we can continue to bring life-saving therapies to patients safely and on time.
Building capability for future patients
As CAR-T and other personalised therapies continue to advance, so too must the systems that support them.
For those interested in joining BioOra, that means contributing skills and expertise at the intersection of science, manufacturing, and patient care. For partners and investors, it means helping build long-term capability that prioritises patient access, safety, and resilience - not just for today’s patients, but for future generations.
In the next volume of Inside the CAR-T Patient Journey, we’ll explore where New Zealand’s current systems fall short in supporting CAR-T and other advanced cell therapies. From reliance on offshore pathways to delays and uncertainty across the patient journey, we’ll examine how system limitations - rather than clinical ones - shape patient access and experience.