Drug Product Manufacturing at 2Y-Biopharma

• Multiple lines for solid and semi-solid dosage forms ranging from pilot to production scales for manufacturing of clinical supplies and commercial drug products
• Oral solid dosages: 4 independent manufacturing suites: ~ 1 billion units per year
• Semi-solid dosages: 3 independent manufacturing suites: ~50million tubes per year
• Dedicated manufacturing lines to support commercial production
• Implementation of Document Management System (DMS), Training Management System (TMS), Warehouse Management System (WMS) and Environmental Monitoring System (EMS)
• GMP warehousing with WMS system
• Primary and secondary packaging of clinical and commercial supplies
• Repackaging, blinding and labeling of clinical samples
• Process transfer, scale-up and validation
• Analytical method transfer and validation
• ICH stability studies
• State issued license covering GMP manufacturing of tablets, hard capsules, granules, powders, cream, ointment and gel, tablets [including anti-cancer drugs (contract manufacturing)]
• Proven track record of successfully passing GMP and pre-approval audits by agencies, clients and third parties, including NMPA, EU QP and MNC audits

Specialties

• Dissolution/Solubility enhancing technologies
       Micronization
       Small and large scale spray dryers and hot melt extruders (Leistritz 12/18) for amorphous solid dispersions
       Freeze drying
• Development and manufacturing of topical semi-solid formulations, e.g. cream, gel, ointment
• Separated and independent suite for oral targeted anti-cancer drug products
• Explosion proof manufacturing capability for solid oral dosages