Biopharma Technology LLC

Biopharma Technology LLC (BTLLC) is a contract development and manufacturing organization (CDMO) headquartered in Carlsbad, California, serving US-based pharmaceutical, biotechnology, and diagnostics companies. The organization leverages over 35 years of specialized expertise in lyophilization (freeze-drying) technology and has completed 5,000+ projects globally.

Core Services

Formulation & Development

• Formulation and cycle development for lyophilized products and liquid formulations
• Product characterization and freeze-dryer system optimization
• Process troubleshooting and scale-up support
• Pre- and post-lyophilization analyses

Manufacturing & Production

• Small-batch production solutions for pharma and diagnostics
• Contract manufacturing with full regulatory compliance
• Lyobead production capabilities
• Diagnostics manufacturing services

Analytical & R&D Services

• R&D analytical services for lyophilization development
• Lab analysis and testing
• Stability studies and process optimization
• Reviews and audits of existing processes

Training & Education

• Expert-led lyophilization training courses, seminars, and webinars
• 3-day lyophilization technology workshops covering formulation, cycle development, scale-up, and freeze-dryer systems

Regulatory & Quality

Fully ISO 13485 (medical device quality management) and ISO 9001 (general quality management) certified. All products and processes are developed with client-owned and controlled intellectual property, ensuring robust, scalable, and future-ready solutions. The organization emphasizes collaborative partnerships and de-risking of development timelines through proven methodologies and industry-leading techniques.