Over 28 years of experience in developing and validating robust compliant immunoassay, immunogenicity, and cell-based assays to support nonclinical and clinical programs.
Preclinical / Non-clinical In Vivo Toxicology
Agilex Biolabs offers a range of toxicology services to support non-clinical through to early/late-phase clinical programs through our state-of-the-art, custom-built GLP facility located in Brisbane, Australia. These services include exploratory (non-GLP) toxicology and pharmacokinetics studies, and GLP toxicology services. We have extensive experience working with a wide range of therapeutic modalities and routes of administration.
TOXICOLOGY
Our scientific experience
Agilex is Australia’s largest and most experienced GLP toxicology lab, combining onshore capabilities and international CRO partnerships to help clients navigate their IND-enabling process. Our team has decades of experience in supporting GLP studies across a range of drug modalities (small molecule, biologics, vaccines, cell and gene therapies) and remains the only GLP lab in Australia to support GLP toxicology studies using immunocompromised animals. If you’re planning your Phase 1 in Australia, speak with our US Board Certified Toxicologists about getting a head start on your preclinical safety data.
애질렉스 바이오랩의 팀은 FDA 및 EMA를 포함한 다양한 국제 규제 기관에 제출하기 위한 규제 독성학 연구를 성공적으로 설계하고 실행한 경험이 풍부합니다.
Our Partnerships
애질렉스는 미국과 아시아 태평양 전역에서 파트너십을 구축하여 고객이 가격, 품질, 일정 사이에서 고민할 필요가 없도록 지원합니다. 이러한 협력을 통해 스폰서는 동종화 가이드라인에 대한 국제 회의에서 명시된 표준 독성 시험에 대한 두 종의 글로벌 요건을 충족할 수 있습니다.
사내
- 모든 생체 내 활동
- 임상 병리학
- 네크로피
- 보고
- 용량 솔루션 분석
- 바이오 분석
- 품질 보증
Outsourced Services
- 조직 병리학
- 제네톡스
- hERG / Ames
- 안전 약리학
- 두 번째 종 연구
전 세계의 제약 스폰서들이 세계에서 가장 효율적인 규제 경로를 활용하기 위해 인간 대상 최초 임상시험(FIH)을 위해 호주로 몰려들고 있습니다. 호주에서 중요한 비임상 시험에 대한 접근성이 높아지면 호주의 공신력 있는 기관에서 수행한 연구를 통해 임상시험 시작을 위한 규제 승인을 보다 간소화할 수 있으므로 추가적인 효율성이 향상됩니다.
Additionally, eligible companies can receive a 43.5% tax rebate on clinical spend and all R&D work placed in Australia preceding an Australia clinical trial – including pharmacokinetics (PK), toxicology testing, and supportive bioanalysis.
Agilex’s growing team of qualified study directors and technicians use Provantis data management software system for study management and data collection, compliant with FDA 21 CFR Part 11. The Provantis software is used for recording body weights, clinical observations, dose administration, food and water consumption, as well as other user specified parametres. Interim and final reporting is facilitated by centralized data management, allowing rapid delivery of written reports to clients.
애질렉스의 비임상 연구 서비스에 대해 더 자세히 알고 싶거나 대기열에 연구를 신청하려면 문의 양식을 작성해 주시면 담당자가 곧 연락을 드릴 것입니다.
OUR TEAM
Toxicology Team
Agilex Biolabs is powered by a multidisciplinary team of over 150 highly trained professionals—scientists, analysts, study directors, and regulatory experts—committed to scientific excellence and client success. Our leadership combines global industry experience with a passion for innovation and quality.
While headquartered in Australia, Agilex Biolabs supports studies across North America, Europe, and Asia-Pacific. Our reputation for proactive communication, flexible service models, and fast turnaround makes us trusted partners for sponsors pursuing novel therapeutics and biosimilars alike.
THE LATEST
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World class technology
Experts in overcoming bioanalytical challenges from new chemical and biological entities.
Agilex offers a wide range of kit productions and logistics services to explore
Supporting non-clinical through to early/late-phase clinical programs through our state-of-the-art, custom-built GLP facilities.
Determine key insights into a therapeutic’s efficacy, safety profile, and mechanism of action.
