At Coho Biologics, we offer a comprehensive suite of RNA and protein therapeutic testing services designed to meet the rigorous demands of modern biotechnology and pharmaceutical development. Our specialized testing capabilities ensure the safety, efficacy, and quality of innovative therapeutics at every stage of development.

Our Testing Services

Potency and Functional Assays

We perform robust potency assays to evaluate the biological activity of RNA and proteins. These tests are tailored to the type of biological function desired, ensuring it meets target specifications for effectiveness.

Our expertise includes:

  • Immunogenicity assays for vaccine candidates.
  • Reporter gene assays for RNA therapeutics.
  • Enzymatic activity measurements for protein drugs.

 

Stability Testing

Our stability studies evaluate how RNA and proteins perform over time under various environmental conditions. These tests are critical for determining shelf life and ensuring product integrity. Our services include:

  • Real-time and accelerated stability studies.
  • Forced degradation testing.

 

Purity and Impurity Analysis

  • To ensure the highest quality standards, we identify and quantify impurities and contaminants. Our analytical methods include:
  • High-performance liquid chromatography (HPLC) for small molecule impurities.
  • SDS-PAGE and Western blot analysis for protein impurities.
  • ELISA for antibody-based quantification of impurities.
  • RT-qPCR for RNA quantification and integrity analysis.

Method Development and Validation

Our team develops and validates analytical methods tailored to your therapeutic product’s unique needs. These services ensure compliance with regulatory standards and reproducibility across batches:

  • Custom assay design and optimization
  • Qualification to meet regulatory guidelines
  • Technology transfer

 

Contamination and Safety Testing

To safeguard patient safety, we conduct rigorous testing for microbial and endotoxin contamination:

  • Sterility testing
  • Mycoplasma detection
  • Endotoxin testing using LAL (Limulus Amebocyte Lysate) assays

Why Choose Our Testing Services?

With cutting-edge technologies and a team of experienced biotechnology researchers, Coho Biologics ensures reliable and accurate data for regulatory compliance and product development. By partnering with us, you gain access to industry-leading expertise and customized testing solutions designed to accelerate your development programs.