Analytics

Overview Analytical Portfolio

 

VelaLabs offers a huge portfolio of a variety of compendial methods, is dedicated to physico-chemical, immuno-chemical methods as well as cell-culture based bioassays - a backbone for every analytical characterization of therapeutic drugs.

 

Compendial Methods

  • Extractable volume (Pharm. EU 2.9.17)

  • Potentiometric determination of pH (Pharm. EU 2.2.3)

  • Osmolality (Pharm. EU 2.2.35)

  • Particulate contamination / visible particles (Pharm. EU 2.9.20)

  • Bacterial endotoxin (Pharm. EU 2.6.14)

  • Particulate contamination / sub-visible particles (Pharm. EU 2.9.19)

  • Density (Pharm. EU 2.2.5)

  • Clarity and degree of opalescence of liquids (Pharm. EU 2.2.1)

  • Degree of coloration of liquids (Pharm EU 2.2.2)

  • Conductivity (Pharm EU 2.2.38)

  • Total protein determination (UV280 , Lowry method, Bradford assay, BCA assay)
    (Pharm EU 2.5.33)

  • Falling ball and automatic rolling ball viscometer methods (Pharm. EU 2.02.49)

 

Physico-chemical Methods

  • Western blotting

  • Host cell impurities (HCP, HCD)

  • High performance liquid chromatography (HPLC)

    • Size exclusion chromatography (SEC)

    • Reversed phase chromatography (RP-HPLC)

    • Ion exchange chromatography (IEX)

    • Ultra -high performance liquid chromatography (UHPLC)

  • Electrophoresis, reducing / non-reducing (SDS-PAGE)

  • Isoelectric focusing (IEF)

  • Gas chromatography (GC)

  • PCR

 

Immuno-chemical Methods

  • Binding and kinetic assays using SPR technology (Biacore)

  • Cytokine measurements (Multiplex)

  • Enzyme-linked immunosorbent assays (ELISA)

  • Electro-chemiluminescence assays (Meso Scale Discovery)

  • Fc-γreceptor binding assays (SPR)

 

VelaLabs has excellent knowledge of scientific rationales to generate customized in-vitro bioassays for a variety of proteins.

 

Cell Culture Based Bioassays

  • (Anti) Proliferation assays based on different read-outs (Fluorescence, luminescence)

  • Antibody dependent cell mediated cytotoxicity (ADCC)

  • Complement dependent cytotoxicity (CDC)

  • Neutralization assays

  • Apoptosis assays

  • Reporter gene assays (RBA)

 

VelaLabs has a long-term experience with different types of potency assays applied for investigation of the mode-of-action of a variety of therapeutic drugs.

 

Potency Assays

  • Varieties of signaling and phosphorylation assays
  • Functional cellular methods based on cyclic AMP
  • Reporter Gene Assays
  • Blood Borne Assays

 

VelaLabs has the technological resources and experience to custom design the optimal bioassay for your product. The company has repeatedly proven to be able to solve specific challenges of assay developments in a large number of clinical indications and types of biological products.

 

Customized Bioassays

  • Upon request

 

VelaLabs can analyze and evaluate binding properties to 45 different natural lectins with unique affinities to carbohydrates with the microarray technology from GlycoTechnica.

 

Lectin Array Technology

  • Upon request

 

VelaLabs has recently expanded its physico-chemical portfolio via the implementation of a range of diverse structure determination methods.

 

Structural Characterization

  • Liquid chromatography mass spectrometry (LC-MS)
  • Gas chromatography mass spectrometry (GC-MS)
  • Size exclusion chromatography multi-angle laser light scattering (SEC-MALS)
  • Capillary electrophoresis (CE)

 

VelaLabs also offers characterization of Leachables and Extractables (L&E) components from the primary packaging materials of (bio-) pharmaceuticals and biosimilars.

 

Determination of Extractables and Leachables

  • Via combination of gas chromatography mass spectrometry (GC-MS), high resolution liquid chromatography quadrupole time-of-flight (Q-TOF), and liquid chromatography mass spectrometry (LC-MS)