GMP for Next Generation Medicines

Our facility is designed to meet international standards for the production of mRNA, CAR-T, MSCs, biologics, and viral vectors.
Manufacturing
  • Modular & Flexible Design
Engineered for rapid scaling and seamless transitions across diverse product lines.
  • Process Segregation by Design

100% Single-Use technology combined with unidirectional flows (personnel/material) to eliminate cross-contamination risks.

  • Precision Climate & Airflow Control
Independent HVAC systems and optimized airflow design ensure uniform air distribution and stable cleanroom environments for concurrent operations.
  • Digital Twin Technology
Uses virtual models to simulate and optimize facility operations, enabling design validation, performance enhancement, and risk prediction.
Quality Control
  • State-of-the Art and Compliant Infrastructure 
Dedicated suites/zones for PCR, sterility testing, and cell culture support with over 40 phase-appropriate qualified QC assays. Our streamlined workflows for sampling and reagent preparation enable the high quality of analytical results while meeting stringent global regulatory requirements.
  • Comprehensive Testing and Release
Integrated QC platforms established for mRNA, cell therapy, gene therapy and biologics. We provide rigorous in-process control and release testing across critical quality attributes, including identity, purity, potency, biosafety and stability, to ensure absolute product safety and clinical efficacy to meet specifications on time in full.
Quality Assurance System
At TBMC, we embed global compliance into day-to-day reliable execution. Our Zhubei GMP facility operates according to FDA Six-System Inspection Model—covering everything from Facilities and Laboratory Control to Production—ensuring your biopharma products meet global standards at every stage of their lifecycles.
To ensure a seamless Batch Release effort, we leverage a phase-appropriate Pharmaceutical Quality System (PQS). By integrating Quality Risk Management and real-time monitoring, we ensure that every batch is supported by robust data integrity, batch-release process and effective deviation/CAP management.
This operational excellence is enabled by the Veeva Vault Quality Suite. By unifying QMS, QualityDocs, and Training into a single cloud-based platform, TBMC provides our customers with dependable timelines, full audit traceability, and the ultimate assurance of quality for their life-saving medicines.
GMP Warehouse
TBMC’s GMP Warehouse is designed to provide controlled, compliant, and traceable storage solutions for next generation medicines, including mRNA, cell therapy, biologics, and viral vector products.
The warehouse integrates controlled non-classified storage, cold chain capabilities, precise temperature control, and material status management to safeguard critical GMP materials, biologic products, and cell banks.
Aligned with GMP and current Good Distribution Practice principles, TBMC’s Warehouse ensures material integrity, end-to-end traceability, and reliable supply support from receiving to storage, issuance, and distribution.

Capacity Overview：

  • mRNA

0.1-6g per batch ;
Supporting up to 13 million dose vaccine annually

  • Cell therapy

Up to 480 CAR-T patients ;
68 batches of MSC production annually

  • Viral vector

200L bioreactor in operation ;
2 X 200L and 1 X 500L systems ready by Q3 2027

  • Biologic

200L bioreactor in operation ;
2 X 2,000L ready by Q3 2027

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