CONTRACT RESEARCH & TOXICOLOGY
Solvias’ Level 4 high-containment facility featuring an isolator system
requires an initial investment of $ 2 – 6 million. Major expenses include pharmaceutical isolators, HVAC systems with double HEPA filtration, and specialised analytical instrumentation.
Beyond the physical infrastructure, additional investments are required for system validation, industrial hygiene programme development, OEB surveillance programmes and facility certification, which can add another $ 0.5 – 1 million to the budget.
Operational expenses also remain significant throughout the facility operations. Routine air and surface monitoring programs, hazardous waste disposal, replacement of single-use PPE, HEPA filter maintenance, service contracts and the resources required for audits, risk assessments and incident investigations all contribute to the high recurring cost of ownership.
In addition to the financial burden, maintaining compliance requires specialised expertise in containment engineering, toxicology, industrial hygiene and occupational safety. For many pharmaceutical and biotechnology companies, building and maintaining such infrastructure internally may not be practical or cost-effective. As a result, outsourcing ADC analytical and development activities to experienced contract research and testing organisations with established containment capabilities has become an increasingly attractive strategy.
Conclusion
ADCs represent a major advancement in targeted cancer therapy, offering the potential for improved efficacy with reduced systemic toxicity. However, the extreme potency that makes these therapies effective also creates challenges for laboratories responsible for their development and testing.
Ensuring safe handling of ADC payloads requires substantial investment in containment infrastructure, rigorous operational controls, and specialised expertise. For many organisations, outsourcing to experienced partners with established HPAPI capabilities provides a practical and cost-effective approach to supporting ADC development while maintaining the highest safety and compliance standards. ●
References: 1: American Cancer Society, Global Cancer Facts & Figures. https:// www. cancer. org / research / cancerfacts-statistics / global-cancer-facts-andfigures. html 2: Frontiers in Cell and Developmental Biology, 2025. |
https:// www. frontiersin. org / journals / cell-and-developmental-biology / articles / 10.3389 / fcell. 2025.1669592 / full 3: Y. Liu et al., Molecular Cancer, 2025. https:// pmc. ncbi. nlm. nih. gov / articles / PMC12044742 / 4: X. Wang et al., Frontiers in Oncology, 2023. |
https:// pmc. ncbi. nlm. nih. gov / articles / PMC10544916 / 5: Therapeutic Oligonucleotides: Methods and Protocols, Royal Society of Chemistry, 2020. https:// doi. org / 10.1039 / 9781788012898 |
Khanh Ngo Courtney
SENIOR FIELD DEVELOPMENT MANAGER, BIOLOGICS CMC
SOLVIAS
k + 1 734 355 7295 J khanh. courtney @ solvias. com j www. solvias. com
|
34 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981