Eurofins BPT offers a range of bioassays to meet the demands of the testing world, all performed under cGMP, EP/USP and ICH guidelines. Test package could include (but not limited to) the following:
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- LC – based techniques (U/HPLC), with several types of detectors available (UV/PDA/DAD.VWD, FLD, CAD, ELSD, MS and RI). For more information on LC based techniques, CLICK HERE.
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- Size exclusion (size heterogeneity, identity)
- Ion – exchange (charged – heterogeneity, identity)
- Reversed-phase (Purity/ impurity, peptide mapping, glycan/ sialic acid analysis, excipient content like histidine, polysorbate, content uniformity)
- Hydrophobic interaction (Purity/ impurity)
- Protein A HPLC (Titre analysis)
- Protein concentration, absorbance, transmittance
- SoloVPE (slope spectroscopy)
- UV Spectrophotometer (Beer – Lambert’s Law)
- Capillary electrophoresis
- CE SDS (size heterogeneity)
- iCE (charge/pI variants)
- Particle size analysis
- Liquid particle counter (Light Obscuration)
- Mastersizer (laser diffraction)
- Zetasizer (light scattering, zeta potential)
- Device testing systems (syringes, auto injectors)
- Break loose force and glide force
- Activation force
- Delivered volume
- Delivery Time
- Needle extension
- Compendia methods
- pH
- Osmolality
- Deliverable volume
- CCI by dye Ingres
- Water content
- Colour and clarity
- Appearance
A dedicated project manager organizes and tracks each client project. The project manager communicates regularly with a team of experts to set up and perform the required testing in a timely manner. Establishing a regular weekly conference call helps to maintain open lines of communication between the client and Eurofins BPT.