The FDA recommends the inclusion of full tissue cross—reactivity data for successful therapeutic antibody IND submissions.
We supply all of the high-quality normal tissues required for both the FDA and EMEA tissue panels. All samples are ethically obtained with full donor or donor family consent, from post-mortem or surgical sources as required.
We tailor each panel to suit your requirements in terms of:-
- Age range and sex of the donors
- Tissues available from a wide range of ethnicities
- Preservation method (flash frozen in liquid nitrogen, slow freezing, dry ice freezing, OCT embedding, FFPE)
- Number of blocks per tissue
- Full and partial panels in terms of donor and tissue numbers
- The standard clinical information will include demographic data (age, sex, ethnicity), cause of death, date of procurement and Post—Mortem Interval (if appropriate). Additional donor information can be provided on request.
Our fully GLP and GCP compliant laboratory can undertake TCR studies, in human and animal tissues. All TCR studies are run to the FDA guidelines. The reporting of the stained tissues is undertaken by a pathologist. A full report is issued covering the IHC optimisation of the test antibody, tabulated results (identifying any positive binding cell, binding intensity and frequency of binding), conclusions and any appropriate images.
In addition to the TCR study we often run studies to identify lead candidates before committing to the main TCR study. This can be in the form of a limited number of tissues or using a TMA.