Comprehensive Testing to Safeguard Your Products

Delivering safe, effective bio/pharmaceuticals demands that every component of your manufacturing process meets the highest standards. This begins with raw materials. Contaminated or non-compliant inputs can cause costly production delays, regulatory setbacks, or worse, compromise patient safety. Early, reliable testing of raw materials is critical to mitigate these risks.

The Eurofins BioPharma Product Testing (BPT) network of laboratories offers comprehensive raw materials and excipient testing services designed to protect your manufacturing processes and ensure the highest quality outcomes. Our global facilities combine extensive chemistry expertise with state-of-the-art instrumentation, delivering dependable results at every phase of bio/pharmaceutical production.

We provide a full range of services, including compendial analysis compliant with USP, Ph. Eur., JP, and other global standards, as well as non-compendial testing for materials not covered by pharmacopoeias. Our capabilities include residual solvents testing, microbial limits testing, elemental analysis, trace metals testing, pharmaceutical water testing, and assessment of thermodynamic properties.

Supporting biologics, gene therapies, and cell therapies, our teams understand the unique complexity of these advanced manufacturing processes. Non-monographed materials, diverse excipients, and evolving production technologies demand the kind of tailored solutions we have become known for.

Our flexible, client-centred approach ensures that testing is aligned with your regulatory strategy, project timelines, and material specifications. Whether you are preparing for IND, BLA submissions or supporting commercial manufacture, the Eurofins BPT network provides the responsiveness in raw materials testing and the confidence you need to move forward.

Our Offering

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Cell Preservation Media, Animal Sera, and Metabolic Growth Factors (e.g. insulin, interleukins, etc.)

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Quality and Functionality Testing per USP <90> and the EP monograph for Fetal Bovine Sera

Total protein content by UV-VIS

Haemoglobin level

IgG and species confirmation (immunochemical assays)

Electrophoretic profile and various assays

pH and Osmolality

Insulin Testing per USP and EP Monographs

Development of various metabolic protein assays

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Chemically Defined Media

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Amino Acid Content and Profile for Pre- and Post-Column AAA

Sugar Profile

Vitamin Profile

pH, Osmolality, Solubility, and Appearance

Trace Metals

Identification and content by amino acid analysis

Platform pH, osmolality, and appearance

Vitamin and sugar content

Growth promotion and functional assays

Microbiological services

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Chromatographic Resins

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Resin Identification – Photoacoustic Spectroscopy (FTIR-PAS)

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Cytokines, Growth Factors, Enzymes, etc.

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Enzyme activity assays and kinetics

Identification and content by ELISA, Dot Blot, Western Blot or other electrophoretic methods

Purity, oligomers and aggregation (SDS-PAGE, SEC, GPC)

Microbiological services

Platform pH and Osmolality

Residual Host Cell DNA, residual Host Cell Protein

Harmonized Microbial Limits Testing

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Enzymes (e.g. proteases, nucleases, etc.)

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SDS-PAGE Identification & Purity

pH and Osmolality

Specific Activity and Kinetics

Methods can be developed with extremely low sample requirements

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Process Buffers, Cryopreservation Solutions, and Chemical Transfection Agents

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Ion identification (wet chemistry, IC and ICP-MS)

Platform pH, conductivity, osmolality, FT-IR, specific gravity

Platform protease, RNase and DNase detection, Phosphatase, Nicking Activity detection

Platform content procedures – titrations, HPLC, GC

Cell Viability/Cytotoxicity assays

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Surfactants / Buffers

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Fingerprint ID by FTIR

Assay and Identification by HPLC-CAD

pH/Osmolality

Ion Identification

Antifoam Testing

RNAse and DNAse detection

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Testing Capabilities

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Complete Compendial Analysis (Ph. Eur., USP,  JP, BP, ACS, FCC)

Residual Solvents

Pharmaceutical Water (Ph. Eur., USP, JP)

Elemental Analysis

Thermodynamic Properties

Trace Metals (USP <232> and <233>)

Harmonized Microbial Limits Testing

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Instrumentation

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  • Agilent 1200, 1260, 1290 UHPLC  
  • Agilent 7890 & 6890 GC with 1888 & 7679A model Headspaces
  • Agilent 8453 UV/Vis Spectrophotometer
  • Agilent VWD, MWD
  • Amino Acid Analyzer
  • Atomic Absorption (AA), Graphite Furnace Atomic Absorption (GFAA)
  • Atomic Absorption Spectroscopy (AAS)
  • BioRad GS-900 Densitometer
  • CHN Analysis
  • Conductivity
  • Differential Scanning Calorimetry (DSC)/TGA/Melting Point 
    Eldex H/D Workstations
  • Fourier Transform-Infrared Spectroscopy
  • Gas Chromatography (GC)
  • Gel Permeation Chromatography (GPC)
  • HPLC-IC/PAD/ELS/RI/MS/UV/DAD
  • ICP/MS, ICP
  • Helena QuickGel System
  • Invitrogen Xcell SureLock™ Mine-Cell
  • LC-QTOF
  • Loss On Drying (LOD)/Gravimetric Analyses
  • Microscopy
  • MTEC PAC 300 Photoacoustic Detector
  • Near Infrared Spectroscopy (NIR)
  • Nitrogen content by Kjeldahl
  • Nuclear Magnetic Resonance Spectroscopy (NMR)
  • Osmometry
  • Pickering Pinnacle PCX Post-Column Derivatizers
  • Polarimetry
  • Residue on Ignition (ROI)
  • Size Exclusion Chromatography (SEC)
  • SpectraMax UV/Vis Plate Reader (96-well and cuvette)
  • Supercritical Fluid Chromatography (SFC)
  • Thermo Corona Ultra, Plus, and Veo CAD
  • Thermo Dionex ICS-5000+ HPIC
  • Thermo Nicolet 6700 FTIR Spectrophotometer
  • Thin Layer Chromatography (TLC)
  • Total Organic Carbon (TOC)
  • Turbidity
  • UV Spectroscopy
  • Viscosity
  • Water Determination by Karl Fischer (Volumetric & Coulometric)
  • Waters 2414 RI Detector
  • Waters Acquity UPLC System
  • Waters Acquity UPLC Systems deactivated for AccQ Tag Derivatization
  • Waters Alliance HPLC System
  • Waters PDA, TUV
  • X-Ray Diffraction (XRD)