
Next Generation Canadian Cell and Gene Therapy
Research & Development Consulting

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.

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
7+
Our staff work with the preeminent provincial, national and international leaders in cell therapy.

Alberta's first CAR-T product
(ACT-C01)
2019


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
+1 780 667 6729
zack@altacel.ca