80 Years Later: The Fight Against Cancer Continues
This year marks the 80th Anniversary of the National Cancer Institute, established by President Franklin D. Roosevelt to support research on the causes, diagnosis, and treatment of cancer. Since the 1940s, cancer researchers have produced nothing short of astonishing science.
The development of antibody drug conjugates (ADCs) ranks among one of the most important advancements in cancer treatments in recent history. The ability to precisely target abnormal cells throughout the body and deliver highly toxic drugs to the center of tumors significantly improves upon the negative side effects of traditional chemotherapies that employ a total war approach to defeating cancer.
Anti-cancer drug development has not come without challenges for pharmaceutical companies that manufacture ADCs. The potency and effectiveness of ADCs are dependent upon engineered nanoparticles (ENPs) — the cytotoxic payload that destroys cancer cells — but little is known about the environmental and human health hazards posed by ENPs. The promise ENPs hold for patients is why we continue to wield them in the quest for a cure despite a full understanding of their key physical characteristics, chemical properties, and associated hazards.
Yet, we can still minimize occupational exposure by applying the precautionary principle. When working with nanoparticles, employers must evaluate workplace-engineering controls and include effective source ventilation and capture protocol to minimize exposure risk. According to the National Institute for Occupational Safety and Health (NIOSH), “A well-designed exhaust ventilation system with a high-efficiency particulate (HEPA) filter should effectively remove nanomaterials.”
Flow Sciences, Inc. has partnered with pharmaceutical companies and laboratories that work with hazardous chemicals like those used in manufacturing ADCs. We specialize in designing task-specific containment enclosures that minimize product loss and exposure to nanoparticles during the complex and sensitive manufacturing processes that characterize ADC production.
The Glovebox Workstation series of enclosures provide containment for toxic applications using highly potent APIs requiring isolation that meets or exceeds ISO 5 clean processing. The Glovebox Workstation comes standard with a HEPA inlet that creates a clean environment ensuring product protection; it also uses horizontal laminar flow to reduce turbulent airflow and reproduce consistent, performance-based results. We have submitted the Glovebox Workstation to third-party testing and confirmed containment levels at or below 50 ng/m3 with balance stability to the 7th decimal place. This makes the Glovebox Workstation ideal for the initial phases of conjugation process development that require accurate methods and precise data with minimal scattering.
ADC development depends upon thorough control and tracking of molecular-level characteristics, including: drug-to-antibody ratio (DAR), monomer content, drug distribution, and cell killing activity or antigen recognition. It also depends upon designing a process that controls for successful experimental parameters within selected ranges so that the manufacturing of ADCs can be scaled up to grams. Certain purification techniques that are crucial in the manufacture of ADCs can only be performed on process solution volumes at the gram scale. As ADC production continues to be scaled up for early clinical phases, the success of the manufacturing process will ultimately depend upon careful analysis and control during the earlier experimental phases.
ADC production requires a laboratory that can handle the initial familiarization phase as well as further investigation, observation, verification, purification, and scale-up. Flow Sciences has designed several containment options that cover the entire scope of ADC development. We offer a Hybrid Isolator for working with highly toxic APIs and the LEV III (local exhaust ventilation) enclosure that is built for scale-up operations. All of our enclosures designed for ADC development have undergone rigorous engineering and performance testing so that you can work confidently as you explore new cancer treatments.