NEW APPROACHES TO CONTAINMENT FOR SMALL SCALE PRODUCTION

摘要

High containment glovebox and isolator manufacturers face new challenges as the High Potency Active Pharmaceutical Ingredient (HPAPI) market is projected to double by 2023 according to Transparency Market Research's latest report. Targeted therapeutics using HPAPIs and cytotoxic drugs show effective treatment at low concentration in major therapeutic areas from oncology, cardiovascular, anti-diabetic to antibody-drug conjugates (ADCs) and have become the focus of researchers and manufacturers worldwide. These compounds present serious occupational hazards, if not handled safely because of their highly toxic nature, and create significant risks of cross-contamination with other products. Patients and operators' health as well as the environment have to be protected from these hazards. As the market is growing, new containment strategies are needed in manufacturing plants to address these risks and strengthen safety requirements. A special focus is also required for R&D and development work on these drugs as their toxicity levels are often unknown during these early stages.