Expedite advancement of your antibody molecules from early stage to commercialization

TaiMed Biologics, founded in 2007, is a leading biopharmaceutical developer and manufacturer in Taiwan. We have extensive monoclonal antibodies (mAb) development and manufacturing experiences and have successfully developed and commercially launched the first and only mAb for HIV treatment in the US and Europe (Brand name: Trogarzo®).

We are proud to offer Contract Development and Manufacturing Organization (CDMO) services for biopharmaceutical companies to propel your important monoclonal antibody molecules from development to market launch.

Our advantage

Taiwan’s highly educated talent pool, stable business environment, and mature regulations make the island ideal for global CDMO service. Our CDMO service team strives to deliver reliable and high-quality development and manufacturing services from our cGMP facility in Taiwan. Being located in the Biomedical Science Park of Taiwan. TaiMed’s experienced team has the advantage of offering high-quality CDMO services at a competitively low cost.

High-Quality and Cost-Competitive
Flexible Manufacturing Solutions
Full Service from Lab to Commercialization
TaiMed’s cGMP facility

Our cGMP facility utilizes single-use technology, offering cost-effective and versatile manufacturing that complies with global regulations. Our services span from pilot scale to full commercialization for monoclonal antibody development. TaiMed is your one-stop integrated solution for all your needs.

Facility Highlights:

  • State-of-the-art five-story building with ~60,000 square foot space supporting cGMP operations.
  • Equipped with the latest technologies for both upstream cell culture and downstream purification operations.
  • US. Food and Drug Administration (FDA)/ European Medicines Agency (EMA) certified QC lab for material/product release and stability analysis.
  • Controlled environment storage for bulk Drug substance (DS) and Drug product (DP) at refrigerated (2-8°C), frozen (-20°C), and controlled room temperature (15-25°C) conditions.
  • In compliance with cGMP and follow ICH, FDA, and EMA Guidance.

Contract Development & Manufacturing Service

Our State-of-the-art cGMP Facility can produce preclinical, clinical, and eventual commercial batches using single-use technology and a broad spectrum of analytical testing instruments.

Our CDMO Service covers GMP manufacturing, upstream/downstream process development, analytical method development and validation, formulation development, and stability testing of monoclonal antibody drug substances.

Our Team has built vast development and manufacturing experiences and has successfully developed and commercialized our own monoclonal antibody.

We offer flexible solutions based on your needs and are committed to supporting the advancement of your project.

Our Services
cGMP Manufacturing

Our cGMP manufacturing services offer 200L, 500L, 2000L scale production using single-use technologies. We have two cell expansion trains, four 2000L single-use bioreactors, three sets of AKTA process systems, and an automatic Ultrafiltration and Diafiltration (UF/DF) system to provide flexible manufacturing capabilities.

Our highly experienced team will work with you to determine the most appropriate production scale for your project and set up a cost-effective production strategy.

State-of-the-art Equipment and Instruments

Upstream process:

  • 50L WAVE bioreactor
  • 200L bioreactors
  • 500L bioreactor
  • 2000L bioreactors
  • Depth filtration systems

Downstream process:

  • AKTA process systems
  • Automatic UF/DF systems

Storage:

  • Refrigerated (2-8°C)
  • Frozen (-20°C)
  • Controlled room temperature (15-25°C)
Process Development – Upstream and Downstream

Our platform process is applicable to handle various types of Chinese hamster ovary cell (CHO) lines. Our upstream process development service offers Culture condition screening and Scalability analysis based on our platform process. Our downstream process development service provides screening of Standardized chromatographic and Filtration process parameters for targeted product quality and scalability.

Our experienced team can provide fit-for-purpose and cost-efficient solutions to enable the rapid development of your program. We comprehensively evaluate manufacturing unit operations, process design, process parameter range selection, processing materials/consumables selection, technology transfer, and process characterization during process development.

We offer non-GMP pilot-scale production (50L scale) and product characterization during upstream and downstream process development to support process scale-up and produce preclinical materials.

Analysis and Analytical Method Development

We have various instruments and have analytical capabilities to perform typical assays required for in-process testing, product release, and product stability testing of mAb drug substances. For each mAb project, our scientists evaluate product characteristics to determine, develop, and qualify analytical methods according to current ICH guidelines and applicable pharmacopeia.

With close monitoring, our quality unit ensures that your mAb is produced and analyzed in compliance with cGMP and meets the appropriate quality and regulatory requirements based on the stage of development.

 
Analysis Services
 
  • Raw material
  • Environment Monitoring
  • In-process control
  • Release Testing
  • Stability Testing
  • Analytical Method Development
Testing Items

Protein Concentration

  • UV/Vis(A280)
  • Titer HPLC

Process-related Impurities

  • Residual Host DNA (qPCR)
  • Residual Host Protein (ELISA)
  • Residual Protein A (ELISA)

Purity and Product-Related Impurity

  • Size Exclusion Chromatography, SEC-HPLC
  • Charge Variant Chromatography, CEX-HPLC
  • CE-SDS (reduced, non-reduced)

Potency

  • Cell-based Assay
  • Binding Assay (ELISA or BLI)

Identity and Characterization

  • Isoelectric Point (PI), measurement with capillary isoelectric focusing (cIEF)
  • N-glycan Profile
  • Peptide Mapping
  • Far and Near UV
  • Circular Dichroism (CD)
  • Intrinsic Fluorescence
  • Differential Scanning Calorimetry
  • Western Blot

Analytical Instruments

  • Liquid Chromatography-Mass Spectrometry (LC-MS)
  • Capillary Isoelectric Focusing (CIEF)
  • Capillary Electrophoresis (CE)
  • Quantitative PCR (qPCR)
  • High-Performance Liquid Chromatography (HPLC)
  • Ultraviolet-visible Spectroscopy (UV/Vis)
  • Turbidity Meter
  • Osmometer
  • Particle Counter
  • BioLayer Interferometry System
Formulation Development

Our staff carries out a phase-appropriate formulation development approach considering the physicochemical and biological properties of your mAb. The development of the formulation composition will consider compatibility with the intended container closure systems to ensure the drug candidate can move forward into clinical and commercial phases. In addition, stability programs will be conducted to support and justify product shelf-life.

Regulatory Affairs Services

With TaiMed’s successful regulatory filing experiences with FDA and EMA, our regulatory affairs team can provide the necessary support to prepare regulatory dossiers for Investigational New Drug Application (IND), Biologic License Application (BLA), and Market Authorization Application (MAA) submissions.

Working with TaiMed CDMO

Working with TaiMed, we will ensure that your important project is being treated as our own with the same high level of scrutiny to Quality, Cost, and Logistical requirements.
We look forward to working with you. To get more information, please contact us now!

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