Our Services

Non-GMP Services

Cell Line Development 細胞株開發
  • Host Cells
  • Animal-component free and chemically-defined
  • DHFR and GS clone selection systems
  • Products: mAb, BsAb, Fc-fusions
  • Clonality confirmation by single cell imaging system
Process Development 製程開發
Upstream Process Development
  • Production/ feed strategy development for CHO cell lines
  • Clone selection in Ambr® 15 bioreactors and shake flasks
  • DoE approach to development
  • Process and product quality optimization in 2L BR
  • Productivity in 2L BR at 2-4 g/L for mAb
  • Cell line stability > 100 PDL
  • RCB banking for MCB manufacturing
  • Process and performance confirmation in 50L BR
  • Maximal scale expected: 250L BR
Downstream Process Development
  • Protein A, CEX, AEX, and mix-mode resin/ membrane screening
  • Buffer design and optimization for each column step
  • DoE approach to development
  • Product: mAb, BsAb and Fc-fusions
  • Process buffer stability and all filter sizing for scale-up
  • Endotoxin removal
  • Reduction of > 5 log HCP after the final purification step
  • Control of CPPs to reach QTPP while having 50-70% overall yield
  • Process confirmation at 50L scale
  • Maximal scale expected: purification from 250L
Analytical Chemistry 化學分析
Bioassay Development 生物檢測開發
  • mAb functional assay
    • Fc effector function (ADCC and CDC)
    • Fab function (surface targeting, signaling, T-cell activation and enzyme blockade)
  • Potency assay
    • Cell proliferation inhibition, cell differentiation and signal-based reporter assays
  • Cytokine/ inflammatory mediator secretion
    • Histamine release, cytokine release, T-cell activation
  • Target binding assay
    • Protein-based and cell-based target binding assays
Bioassay Development 生物檢測開發
Formulation Development 配方開發
  • pH and excipient DoE screening
  • Long-term and accelerated stability studies and freeze-thawing cycle testing
  • Tm determination using DSC to guide formulation development
  • Development of high concentration formulation >100 mg/mL mAb
  • Process optimization at 2L scale
  • Process confirmation at 50L scale
  • Experiences in low yielding and hard-to-formulate BsAb
Formulation Development 配方開發

CDMO Services

One-Stop-Shop CDMO Services! Our group member—Tanvex BioPharma USA, with facilities in San Diego, CA, can provide scale up process development and commercial production.

Biosimilar

Tanvex Biologics has long been committed to the field of cancer treatments, possessing outstanding R&D capabilities and a wealth of experience in developing biosimilars and novel biologics. Its two major biosimilar products—TX01 (Neupogen Biosimilar) and TX05 (Herceptin Biosimilar)—are approaching the market stage. Our extensive R&D capacity and professional team can help customers quickly carry out process development, scale up production, and optimize processes. During the preclinical development and design phase, we can assist with correcting potential bottlenecks that may occur during future mass production and commercialization to achieve maximum results.

Novel Biologics

  • Antibody-Drug Conjugates (ADC)
  • Nanoparticle
  • Immunocytokines (ImC)
  • Bispecific antibody (BsAb)