| August 2009 | Print Article |
Comparative Biosciences Phone: 408.738.9260 |
Toxicology Capabilities at Comparative Biosciences Comparative Biosciences offers a complete program of GLP IND and BLA enabling toxicology for small molecules and biologics including viral, stem cells, vaccines, nanoparticles, and devices. CBI has completed over one-thousand successful GLP toxicology studies for both small companies and big-pharma CBI provides state of the art toxicology services to the biopharmaceutical industry.
Discovery Toxicology Discovery toxicology is a key process in the identification and characterization, and selection of new products for development. CBI offers a number of fast, inexpensive research programs designed to assess, characterize and rank new molecules for toxicity and efficacy and to assist in the selection process. For early discovery projects, CBI also offers a range of nonGLP exploratory toxicity studies for early assessment of molecules including single dose, multiple dose, and targeted studies as well as directed or investigative toxicology.Investigative-Custom-Special Toxicology There is often a need for specialized and complex toxicology studies, generally to address unanticipated or unusual toxicologic events or to conduct toxicology studies that are of a difficult or unusual nature. These studies are directed, hypothesis driven, and may have specialized or unusual techniques or methods. In some cases they are requested by the FDA or by clinicians. Examples might include CT or PET scanning, specialized immunohistochemistry, surgical aspects, stereotaxic delivery, application of test article surgically, or esoteric blood samples. The skilled scientists at CBI can facilitate the protocol development as well as the conduct of these difficult and specialized projects.
Species include rodents, small animals, ferrets, gerbils, rabbits, dogs and pigs/minipigs, by standard and unusual or specialized routes of administration. We feature rapid study initiation and report preparation to meet sponsor deadlines or milestones. We comply with FDA, OECD, and IHC guidelines and have a validated computerized toxicology data acquisition program. Our study directors are board certified, experienced, communicative, and attentive, and we produce high quality GLP reports in a very timely fashion. We specialize in toxicology packages for unusual or problematic test articles/indications or aggressive time lines. Recent examples of unusual delivery routes would include successful studies using intracerebral or stereotaxic delivery, intranasal delivery, myocardial delivery, intratumoral delivery, intrarectal delivery, human stem cells, and virus-associated test articles. CBI has completed more than 1000 successful GLP studies. Stem Cell Studies at CBI CBI is poised to conduct and support Stem Cell Research. Our highly trained staff is experienced in the area of GLP regulatory studies, toxicology, pharmacokinetics, radiolabel, pharmacology, histology, and immunohistochemistry. Our scientists are versed in the FDA requirements for Stem Cell Packages, including recommendations on species selection, proof of concept studies, appropriate sized groups, and duration of studies. Clinical relevance, appropriate comparative anatomy and physiology, relevant clinical route of administration and immune tolerance are pivotal issues in study design. Toxicity studies are often conducted in the relevant disease model. Key comprehensive assessments include disposition of the stem cells following injection, possible formation of ectopic tissues, tumor formation, site reactions, and functional impact.Copyright © 2009 Comparative Biosciences, Inc. All rights reserved |