Home Pharma Reproductive and (neuro)developmental toxicology Immunomodulation by (bio) pharmaceuticals: our experience
Immunomodulation by (bio) pharmaceuticals: our experience
Tailor-made test methods are offered to study the unintended adverse effects of human pharmaceuticals on the immune system (immunotoxicology, immunogenicity) or the intended modulation of the immune system (immunopharmacology), both of which may result in suppression or enhancement of the immune response.In addition to studying the (un)intended effects of human (bio)pharmaceuticals in rodents and dogs, we recently gained experience for (immuno)safety studies in minipigs as an additional non-rodent species. New developments with (bio)pharmaceuticals in minipigs are:
- Immunotoxicity testing (ICH S8, 2006) Effects of (bio)pharmaceuticals on Immune Pathology and Immune Functions
- Immunogenicity testing (ICH S6, EMA/CHMP/BMWP/14327/2006) Anti Drug Antibodies (ADA), Neutralizing Antibodies(NAB) and Pharmaco-Kinetics
- Juvenile (immuno)developmental studies (EMA/CHMP/SWP/169215/2005, EMA/536810/2008, FDA,2006) Effects on Immune Pathology and Immune Functions at different stages of development
Immune modulation approaches
Immune modulation by (bio)pharmaceuticals can be studied by a large panel of Immune Pathology markers and Immune Function tests:
- Immune Pathology lymphoid organ weight and pathology, WBC differentiation, lymphocyte subset analysis etc
- Immune Function studies focused on innate- (e.g. NK cells) and acquired immunity (e.g. TDAR, PFC- and KLH assay)
- Host resistance models Bacterial-(Listeria monocytogenes) and virus (flu) models
- Hypersensitivity testing Type 1 humoral sensitisation- and Type 4 cellular sensitisation tests
- Immunogenicity testing
- Vaccine/adjuvant safety and efficacy testing
- Challenge studies with mice adapted flu strains