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Biotech-Catalog In Vivo Assays |
In Vivo Assays | AppTec offers a variety of approved testing procedures to evaluate the biological safety of your products. AppTec’s animal facility is fully accredited by AAALAC and is fully equipped to appropriately care for mice, rats, hamsters, guinea pigs, rabbits, ducks and other small animals.
In this section
| CUSTOM ASSAYS In addition to services listed above, AppTec also provides custom in vivo testing services, which include antibody production (e.g., DNA-based, peptide, protein immunogens and monoclonal antibody production), biohybrid device testing, sensitization testing, tumorigenicity in nude mice, assay development and validation services. Contact your Account Manager for more information.
| | General Safety Test Back to Top |
| 30003 | This assay detects extraneous contaminants of biological products. According to 21 CFR 610.11, specific pathogen-free (SPF) guinea pigs and mice are inoculated with the test article and observed for 7 days. Each test animal is weighed prior to inoculation and then again on the last day of the test. Any weight loss or response that is not expected from the product may indicate the presence of a contaminant. Control animals may be run in parallel with the test article, per sponsor request. Notes
· A volume of 12 ml of the final product is required.
· If the product is freeze-dried, include reconstitution instructions and diluent.
· If a specific dose/concentration is to be used, be sure to specify. |
General Safety Test:
21 CFR 610.11
Turnaround Time:
3 weeks
Container/Volume:
1 x 12 ml Shipment Temperature:
Per client's discretion |
| The USP 25 Systemic Injection Test is also available.
Contact your Account Manager for more information. | | f | | Pyrogenicity Back to Top |
| 30019 | This assay determines if pyrogens are present in the test article by intravenous inoculation of rabbits with final product or extracts of final product. Body temperatures are monitored for three hours for evidence of febrile responses. Notes
· Submit enough material for a total of eight 3 kg rabbits to be administered the equivalent of the maximum recommended single human dose (on a proportionally body weight basis), but not exceeding 10 ml/kg rabbit body weight.
· Sample must be shipped frozen and sent in pyrogen-free containers.
· Submit sample from the beginning, middle and end of each lot. |
Rabbit Pyrogenicity Test:
USP 23 [151]
Turnaround Time:
2 weeks
Container/Volume:
See Notes. Shipment Temperature:
Frozen on dry ice |
| | f | | Tumorigenicity Back to Top |
| 30017 | This assay determines the ability of test article cells to form tumors in athymic nude mice. Ten nude mice are inoculated with the test article cells, and ten mice with the tumor-forming cell line HT-1080 (positive control), and five mice with Eagle’s Minimal Essential Medium (negative control). Nodules formed are measured in two dimensions to determine progressive growth. During necropsy each animal is examined for the presence of tumors at the site of inoculation and elsewhere. Histopathology is performed upon tumors, the site of inoculation and selected internal organs. Notes
· If suspension cells, the appropriate number of viable cells should be sent in T25 or T75 flasks which are filled almost to the top with medium, capped tightly and sealed with Parafilm®. Some air space is required to allow for expansion and contraction of liquid during shipping.
· If anchorage-dependent cells, the appropriate number of subconfluent (50% to 80%) cultures should be sent in T25 or T75 flasks as described above.
· Provide pertinent passage instructions, as well as sufficient growth medium and supplements for two weeks in culture. |
In Vivo Tumorigenicity: Tumor Formation in Nude Mice,
Single Inoculation,
Extended Period (12 weeks)
Turnaround Time:
17 weeks Container/Volume:
1.1 x 108 viable cells Shipment Temperature:
Ambient |
| Custom tumorigenicity assays can be designed to assist in FDA OVRR and PTC requirements. Contact your Account Manager for more information. | | f | Back to Top |
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