| Assay number | Test | Verbal result after |
| BT 707A |
Cross reactivity with Normal Human Tissues
- Protocol in full compliance with current FDA and EC-guidelines.
- Immunoperoxidase test on tissue sections (several unrelated donors) of:
| Adrenal (USP/EC) | Kidney (USP/EC) | Skin (USP/EC) |
| Bladder (USP/EC) | Liver (USP/EC) | Spinal cord (USP) |
| Blood cells (USP/EC) | Lung (USP/EC) | Spleen (USP/EC) |
| Blood vessels (USP/EC) | Lymph node (USP/EC) | Striated muscle (USP/EC) |
| Bone marrow (USP/EC) | Ovary (USP/EC) | Testis (USP/EC) |
| Breast (USP) | Pancreas (USP/EC) | Thymus (USP/EC)* |
| Brain (USP/EC) | Parathyroid (USP/EC) | Thyroid (UPS/EC) |
| Colon (USP) | Parotid (EC) | Tonsil (EC) |
| Eye (USP)* | Peripheral nerve (EC) | Ureter (USP) |
| Fallopian tube (USP) | Pituitary (USP/EC) | Uterus (USP) |
| Gastrointestinal (USP/EC) | Placenta (USP) | |
| Heart (USP/EC) | Prostate (USP) | |
* not always readily obtainable | 12 weeks |
| BT 801 |
Iso-enzyme Analysis of Cell Lines
- Species identification of the cell line involved (e.g. mouse, hamster, human etc.).
- Contamination with a cell line of another species can be demonstrated.
- Concurrent positive and negative controls.
| 2 weeks |
| BT 803 |
SDS-Page Analysis
- Assay aimed at the detection of contaminating proteins in monoclonal antibody preparations.
- Assay performed under reduced and non-reduced conditions.
| 2 weeks |
| BT 806 |
Isotype Determination of Immunoglobulines
- Confirmation of the isotype (sub) class of monoclonal antibody preparations.
- All known antibody (sub) classes for either murine of human included.
| 2 weeks |
| BT 807 |
DNA-fingerprinting of Cell Lines
- Assay aimed at identifying cell lines by means of DNA-technology.
- Recommended assay for comparison of reference cell line and in-process samples.
| 3 weeks |
| BT 825 |
Determination of Residual Insulin
- Highly sensitive quantitative radio-immuno assay (below 1 ppm).
- Several insulin spikes are included to determine effects of test sample.
| 3 weeks |
| BT 826 |
Determination of Residual Human Albumin
- Sensitive quantitative nephelometrical test (below 20 µg/ml).
- Several albumin spikes are included to determine effects of test sample.
| 3 weeks |
| BT 827 |
Determination of Residual Human Transferrin
- Sensitive quantitative nephelometrical test (below 20 µg/ml).
- Several transferrin spikes are included to determine effects of test.
| 3 weeks |
| BT 828 |
Determination of Residual tri-n-butylphosphate (TNBP)
- Highly sensitive quantitative method by means of gas chromatography.
| 2 weeks |
| BT 829 |
Determination of Residual Tween 80
- Sensitive quantitative colorimetrical method.
- Spike sample with Tween 80 is included for correction of loss during extraction.
| 2 weeks |
| Custom |
Potency
- Biological activity and immunologica activity (in vivo and/or in vitro).
| depending upon protocol |
