Next Generation Canadian Cell and Gene Therapy

Research & Development Consulting

Our mission is simple. 

 

Help carry your technology to the patients who need it.

 

Success enabled by years of cross-cutting translational experience

 

 

 

Preclinical Studies

Choosing your nonclinical testing strategy for novel modalities, particularly cell and gene therapeutics can seem daunting. We provide the latest regulatory guidances, specific to your location, along with years of real-world experience working with biotechs and academics, to help create for you the optimal preclinical studies plan, specifically tailored to your advanced technology and clinical goals.

 

Next, we engage regulators proactively with the right questions to de-risk and give you the clearest picture of what you need to take the next step in clinical development. 

 

Lastly, we provide an objective review of your preclinical data quality and prepare it into a final package for submission to the regulatory authorities, and for use in development of other documents. 

Quality and Manufacturing

We are passionate about clinical manufacturing. Over the past ten years, we have worked with some of Alberta's best scientists, and driven provincial expansion into advanced therapeutics manufacturing at both major academic centres.

 

Let us put that expertise to work for you in bringing to life your technology. 

 

Modalities: Genetically Engineered T-cells, Base-edited Hematopoietic Stem Cells, Viral-specific T cells, Ex vivo cultured Macrophages, Rare T-cell Subsets, Antisense Oligonucleotides

 

 

 

Regulatory Affairs

 

 
 

 

 

We understand the Canadian regulatory landscape.

In fact, we are working with partners across the country through non-profit advocacy and innovation to make it more efficient and effective.  

 

From nonclinical to CMC, from clinical trial protocol to application, we have the experience and vision to help you meet the regulatory requirements every step of the way. 

The Leader in Early-Phase Canadian Cell Therapy

We partner with academia and biotech teams to accelerate cell, gene, and novel biologic programs. Our staff come with industry-leading experience across therapeutic areas and modalities.

7+

Products

10+

indications

5+

Modalities

7+

Approved clinical trials

Nearly two decades of experience in Canadian clinical oncology research

Our staff work with the preeminent provincial, national and international leaders in cell therapy. 

Alberta's first CAR-T product

(ACT-C01) 

2019

Canada's first solid tumour CAR-T product

(GCAR1)

2024

Publications

New preprint: Development and first-in-human CAR T therapy against the pathognomonic MiT-fusion 2 driven protein GPNMB. MedRxiv. 2026

ACIT001/EXC002 Clinical Trial Publication

Contact Us

Please reach out for a complete list of contractable services and a current price list. 

+1 780 667 6729

zack@altacel.ca

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