Biological Testing Services

Biological products such as biopharmaceuticals and diagnostics require stringent testing prior to FDA submission.  Below are some of the services we offer to assist you.

Release Testing

Haemtech can perform lot release testing on your IVD or biopharmaceutical product.  We can help you determine which tests are the most suitable, and help you establish the appropriate acceptance criteria. 

Stability Testing

Using state-of-the-art climate control chambers in conjunction with USP/EP compliant testing methods, Haemtech can determine the long-term stability of your product through both accelerated and real-time stability studies.

Product Characterization Services

Our characterization methods include, but are not limited to, HPLC, ELISA, densitometry, SDS-PAGE, Western blot, residual moisture, and isoelectric point determination.