Nomination to ICCVAM: BoTestTM Botulinum Neurotoxin Detection Kits

Test Method Nomination to the ICCVAM Nomination of Alternative Methods to Replace the Mouse LD50 Assay for Botulinum Toxin Potency Testing

Alternatives to the LD50 assay for botulinum toxin potency testing: Strategies and progress towards refinement, reduction and replacement

Therapeutic preparations of botulinum toxin products are calibrated by a mouse LD50 assay, and the labelled unit of activity is expressed in mouse LD50 units, defined as the median lethal intraperitoneal dose at a defined time-point. Potency and stability testing are required at several stages of the production process. Testing at the final lot stage requires high precision, so a large number o...

Expression and Purification of Neurotoxin-Associated Protein HA-33/A from Clostridium botulinum and Evaluation of Its Antigenicity

Background: Botulinum neurotoxin (BoNT) complexes consist of neurotoxin and neurotoxin-associated proteins. Hemagglutinin-33 (HA-33) is a member of BoNT type A (BoNT/A) complex. Considering the protective role of HA-33 in preservation of BoNT/A in gastrointestinal harsh conditions and also its adjuvant role, recombinant production of this protein is favorable. Thus in this study, HA-33 was expr...

Immunogenic and Protective Potentials of Recombinant Receptor Binding Domain and a C-Terminal Fragment of Clostridium botulinum Neurotoxin Type E

Clostridium Botulinum Type E neurotoxin heavy chain consists of two domains: the translocation domain asthe N-terminal half and the binding domain as the Cterminal half (Hc). One effective way to neutralize botulinum neurotoxin is to inhibit binding of this toxin to neuromuscular synapses with antibodies against binding domain. Two synthetic genes, coding for Hc (the full length binding d...

Nomination of the National Toxicology Program Rodent Bioassay for ICCVAM Review and Validation This nomination is made in accordance with Public Law 106–545 SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF ALTERNATIVE

SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF ALTERNATIVE METHODS. (b) PURPOSES.—The purposes of the ICCVAM shall be to— (1) increase the efficiency and effectiveness of Federal agency test method review; (2) eliminate unnecessary duplicative efforts and share experiences between Federal regulatory agencies; and (e) DUTIES.—The ICCVAM shall, consistent with the purposes descri...