How do you ensure that the pool does not contain byproducts that cause inhibition of T-cell responses or give false positive responses?
Danger of false positive T-cell responses or inhibition of T-cell responses by toxic contaminants depend on peptide specification. Together with our clinical collaboration partners JPT developed synthesis and purification protocols which avoid presence of contaminants causing false positive T-cell responses or inhibition of T-cell responses by toxic byproducts to a large extent. In addition, JPT established QC procedures ensuring a high level of batch to batch reproducibility. Positive control pools will be QC’s for chemical purity and integrity as well as biological performance. JPT’s pooling strategy is validated and was audited to be in accordance with DIN ISO 9001:2000 and GCLP requirements.
