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API Manufacturing & Management Practices

PRODUCT LIST    Home    Products    Bulk Drugs Pharmaceuticals    Chemicals    API    Pharmaceuticals API List    Chemicals    Manufacturing    Product Development    Product Search    Agro Chemicals    Custom Pharma Services    Contact Us	High Potent and Cytotoxic Manufacture   Taj offers a global solution for all your high potency needs. Our high containment facility in Harrisonville, Missouri, USA, provides the rigorous controls necessary to develop and manufacture both new and existing anti-cancer drugs and other high potency compounds. This state-of-the-art plant is one of only a few facilities worldwide specifically designed to manufacture this class of drug. Taj's scientific staff offers 50 years of experience in handling and producing high potency APIs. The facility is fully Class 100,000 and was designed using the latest in barrier technology, including isolators and clean-in-place systems. The facility contains three separate suites, each on its own air handling system (HEPA filtration both inbound and exhaust) with separate access and egress points. * The first suite is a glassware laboratory for preclinical development synthesis and kilo-scale batches. The room is equipped with a 100L Büchi ChemReactor, a walk-in hood for up to 50L glassware, and a glove box for product isolation and packaging. * The second and third suites are utilized for the production of clinical and commercial supplies. Both rooms contain custom isolators that incorporate filtration, drying and packaging. The reactors (up to 1000L) feed directly into these units with waste pumped to storage tanks that are then shipped for incineration. No direct handling of materials by personnel is required. Taj has recently completed an investment in high potency capability at its Oxford, UK, facility to handle materials down to 0.5 µgm-3 at up to 1600L scale. The facility was designed in conjunction with SafeBridge, utilized current containment and people flow best practices, offering isolation on either centrifuge or filter dryer in class 100,000 spaces. Taj’s Indian facilities offer a full range of scales for high potency and cytotoxic manufacture, including milling, in dedicated laboratories, pilot plant, and commercial scale manufacturing at up to 3500L scale. These facilities utilize glovebox technology, and safebreak connections to ensure personal protective equipment is not the primary means of containment. Taj Laurus designed a separate cytotoxic/high potency facility on its campus, in order to maintain isolated suites ideal for this class of compound.

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