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.