Biotherapeutics like cell and gene therapies, nucleic acids, and proteins show promise for treating many neurodegenerative disorders. Since research using these modalities is expanding, understanding their potential to induce novel neuropathologic changes is vital for successful preclinical testing.

In the 2024 article titled “Toxicologic Neuropathology of Novel Biotherapeutics,” StageBio Senior Director of Medical Device and Neuropathology, Sarah Cramer, DVM, PhD, DACVP, joins co-authors in summarizing key takeaways from a recent continuing education course that focused on toxicologic neuropathology of neuro-targeted biotherapeutics.

A reference for preclinical safety testing and risk assessment of novel neuroactive biologics

The article, published in Sage Journals, covers topics that include:

• Fundamental neurobiology
• Pharmacology
• Neurotoxicity

Specific biotherapeutic classes discussed in the article include:

• Cell and gene therapies
• Nucleic acids
• Proteins

Details offered in this article will help researchers design effective and thorough preclinical experiments using bio-derived test articles. The article will also be useful in understanding data evaluation and interpretation. For example, Cramer and colleagues explain “expanded neurohistopathology” would often be recommended for evaluations of neuroactive biotherapeutics.

Access the article at Sage Journals

Read the article to gain more insights into preclinical safety and risk assessment of biotherapeutic modalities.