Technologies

TBMC will leverage existing resources to integrate intelligent and smart platform to establish various biopharmaceuticals manufacturing facility.

Technologies

TBMC will leverage existing resources to integrate intelligent and smart platform to establish various biopharmaceuticals manufacturing facility.

Digital Manufacturing Platform

Data
Center

Inline data collection
Data analysis & integration

Intelligent
Center

Deep Learning
Modeling & simulation

Control
Center

Model predictive control

Real-time
Monitoring System

Automatic
Feedback Control

Real-time
Monitoring System

  • Linking manufacturing
    equipment and monitoring instruments
    Seamlessly integrating upstream and downstream devices, as well as various types of analytical instruments.
  • Real-time data transmission to the data center
    Different equipment transmitting data to the processing center via OPC.

Data Collection
and Processing

  • Automated equipment analysis and online process data analysis
    The data center analyzes and manages uploaded data at any time, providing real-time insights.

Cloud
Storage

  • Paperless operation throughout the entire facility
    Cloud-based digital transmission of important parameters, achieving a paperless manufacturing process.
  • Cloud network connecting various plants
  • manufacturing parameter data transmitted between networks, allowing smooth data flow between different plants and simultaneously collecting data from various production lines.

mRNA Drug

TBMC provide one-shop mRNA production service from research to clinical stage with advanced one-step synthesis technology

Target DNA

mRNA

mRNA-LNP

Drug Product

Service for research and pre-clinical stage: provide high quality plasmid DNA production, mRNA sequence optimization, mRNA IVT, and mRNA-LNP packaging services
Scale｜1mL～5L（mg to 10 g）
Service for clinical or marketing stage： high quality plasmid DNA production, mRNA sequence optimization, mRNA IVT, mRNA-LNP packaging, and DP fill-in

Viral Vector

TBMC provides end-to-end one shop service for lentiviral vector or adeno associate viral vector production

LVV
Target DNA

Transfection

LVV

Drug Product

AAV
Target DNA

Transfection​

AAV

Drug Product

Service for research and pre-clinical stage：provide viral suspension cell culture process development、viral vector production and purification
Scale｜250mL～5L
Service for clinical or marketing stage：viral vector production、 purificaition and PD fill-in

Cell Therapy

TBMC is developing an automated platform for the mass production of MSC and cancer immunotherapy cell therapy drugs. We also offer comprehensive one-stop services including IRB planning and writing, process development, QC method establishment, functional verification, CMC (Chemistry, Manufacturing, and Controls) document preparation, as well as clinical trial design.

Tissue/Cell source

．Tissue collection IRB
．Pathogen detection
．Cell separation and purification
．Cell cryopreservation

Cell manufacturing

．Cell culture scale-up, process development
．QC method development
．Cell product spec
．In vitro assay

Safety and Efficacy Test

．In vivo assay
．Toxicity Study
．Dosage test
．Stability test

Clinical Trial IND

．CMC document
．Clinical trial protocol
．IND document
．Clinical trial

Market NDA

．Clinical trial data analysis
．BLA application
．Production manufacturing and process optimization
Service for research and pre-clinical stage：MSC and cancer immunotherapy cell production
Scale｜10-50 doses/batch
Service for clinical or marketing stage：MSC and cancer immunotherapy cell production

CHO-C Protein Drug Platform

TBMC develops proprietary CHO-C platform aiming to provide end-to-end protein production services from research to marketing stage

10,000
100
10
10,000
Number of sequences

Target
Identification

Target
Validation

Lead
Selection

Lead
Optimization

Preclinical
Development

> 100mg in 10 days
2~5 g/L in 4 months

HD CHO-C transient protein production system

∙ CHO-C cell line
∙ Sweet CHO-C cell line (On-going)

Workflow for CHO-C Cell line Development

Step 1

In silico prediction of signal peptide for GOI
TBMC’s proprietary SP (patented)

Step 2

Codon optimization and gene synthesis / Subcloning
TBMC’s proprietary plasmid vectors

．Optimal HC / LC ratio
． Freedom-to-operate

Step 3

Transient Production with HD CHO-C
．Prediction of the future titer
．Good quantity and quality
．Deliver > 100 mg in 7 days

Step 4

Generation of stable pools
． Antibiotics and MTX selection
． 700~1000 mg/L

Step 5

Selection of single clones and generation of RCB
． Ensure clonality with image
． 3 out of 500 clones
． Stability over 60 generation
Service for research and pre-clinical stage：Rapid protein production and purification, cell line development, and process development
Scale｜30mL to 50L (single-use or disposable bioreactor)
Service for clinical or marketing stage：MCB setup, protein manufacturing, quality analysis, and PD fill-in