Anacura

AnaBioTec provides analytical solutions for your product filing from pre-clinical to market.

Based on our extensive experience we focus on the analytics that matters & help you to connect the dots for your product across all aspects of your analytical needs.

Pre-Clinical

  • Method & assay development
  • Method qualification
  • Accelerated stability studies
  • Comparability
  • Release
  • Reference standard establishment
  • IND
  • IMPD

Clinical

  • Method validation
  • Forced degradation
  • ICH stability studies
  • Process control through comparability
  • Release
  • Reference standard management & Trending
  • BLA
  • NDA

Market

  • Release
  • Stability
  • Trending

Where we make the difference

What's in our portfolio?

AnaBioTec exibits an extensive experience with complex formulations / mixtures, liposomal products, low solubility products, microspheres & derivatised products.

NCE
NBE
CBMP
AnaBioTec covers a wide spectrum of products
  • Derivatives
  • Vaccines
  • Plasmid
  • mRNA
  • mAb
  • Stem cells
  • Peptides
  • Oligo
  • Car-T
  • BMPCs
  • Compounds
What we can

Our testing capabilities

Testing capabilities

Chromatography / Electrophoresis

  • HPLC & UPLC (UV/DAD/CAD/MS/ELSD/FLD)
  • Gas chromatography (GC)
    • liquid & headspace
    • FID & TCD
  • Capillary electrophoresis (CE)

Physico-chemical testing

  • Differential Scanning Calorimetry (DSC)
  • Laser Diffraction
  • Light obscuration
  • Hardness
  • Disintegration
  • Friability
  • XRD

Mass spectrometry

  • LC-MS

Karl Fischer

  • Volumetric
  • Coulometric (with/without VAP)

Spectroscopy

  • FT-IR
  • UV-VIS

Dissolution

  • USP type 1 (baskets)
  • USP type 2 (paddles)
  • QC (real-time & accelerated)
  • Biorelevant

Wet chemistry

  • Osmolality
  • pH
  • Density
  • Viscosity
  • Heavy metals
  • Sulfated ash
  • Titration

Other

  • Water activity
  • Appearance 

Color, particulate matter, visible particles

  • Solubility
  • Microbiology (outsourced)
  • Endotoxines

Testing capabilities

Identity & purity

  • Molecular weight
  • Size distribution
  • Charge variants
  • Glycosylation profile
  • Disulphide bridges
  • Drug-to-antibody ratio (DAR)

Impurities

  • Degradation
  • Physical modifications
  • Chemical modifications

Quantity

  • Total protein content
  • In matrix (serum, CSF)

Potency

  • Immunoassays
  • Enzymatic assays
  • Cell-based assays

General quality

  • Appearance
  • pH
  • Osmolality
  • Particulate matter
  • Moisture content

Process impurities & contaminants

  • Host-derived (HCPs, DNA)
  • Downstream / culture-derived
  • Residual solvents / chemicals / biochemicals / inorganic salts
  • Medium components
  • Mycoplasma
  • Sterility
  • Endotoxins

Testing capabilities

Characterization

  • Multiplex testing (8 colours) by FACS
  • Primer and probe design
  • Electrochemiluminescence (MSD)

Identity

  • Single/ multiple protein marker(s)
  • Absence of marker(s)
  • Protein secretion
  • Gene expression
  • Distribution by flow cytometry

Purity

  • Percentage of dead cells & undesired cells
  • Ratio viability
  • MHCII

Quantity

  • Cell viability
  • Cell count

Potency

  • Biomarkes
  • ELISA
  • Gene expression by RT-qPCR
  • Enzymatic assays
  • Flow cytometry
  • Mixed lymphocyte reaction (MLR) assay

General quality

  • Appearance
  • pH
  • Osmolality

Process related impurities & contaminants

  • Host-derived (HCPs, DNA)
  • Downstream/ cultured-derived
  • Residual solvents/ chemicals/ biochemical/ inorganic salts
  • Medium components
  • Mycoplasma
  • Sterility
  • Endotoxins

Meet our scientist

Contact us