Biopharmaceutical Testing

Bioanalysis with an expert perspective

At Cambrex we’ve got the tools, insight and world-class expertise to support your demanding biopharmaceutical testing needs.

We work closely with biotech start-ups and established biopharma companies to evaluate the quality, purity, safety and other key attributes of candidate viral therapies and large molecules at all phases of the preclinical and clinical development pipeline.

We offer a comprehensive suite of testing services for complex biopharmaceutic products, including mammalian and bacterial viruses as well as other large molecules as well as monoclonal antibodies, RNA and DNA, enzymes, peptides, lipids and carbohydrates.

Delivering insights to drive your business forward.

Your local partner – With a network of facilities across North America and Europe we’re always within reach to address your analytical and testing requirements.

Always innovating – With continuous investment in state-of-the-art tools and processes Cambrex is at the forefront of biopharmaceutical testing innovation.

Results focused – At Cambrex we understand the importance of delivering timely, accurate and trustworthy biopharmaceutical test results that our clients depend on.

Consultative approach – We’ll work with you to understand your analytical needs and deliver a testing programme that meets your technological and commercial objectives.

Biopharmaceutical testing:

General Attributes and Compendial Testing

  • Appearance
  • pH, conductivity
  • Osmolality
  • Volume in container
  • Particulate analysis (visible, HIAC)

Activity/Potency and Assay

  • Bacteriophage and mammalian viruses titering plaque assay
  • ELISA (i.e. mAb)
  • Impedance assay (xCELLigence)
  • Specific Activity and Enzyme Kinetics (96 and 348 well plate) fluorescent and absorbance assays, HPLC-UV and Ion-pairing assay, gel shift assay (i.e. polymerase assay with imaging system), broken beacon (qPCR tandem plate reader polymerase assay)
  • Assay (HPLC/UPLC-UV,-FLD,-CAD, -ELSD, SEC-UV-RID-MALS, SDS-PAGE, UV-VIS, CE-PAGE)

ID, Purity and Heterogeneity

  • Purity (CZE, CE-SDS, and cIEF, RP-HPLC, SEC-UV-RID-MALS, SDS-PAGE, UV-VIS)
  • Marker gene expression, western blot, end point PCR, fluorescent, luminescent, and absorbance imaging
  • Copy number by qPCR and soon dPCR
  • NGS (MiSeq)
  • Nanoparticle size (i.e. aggregation)

Impurities

  • Biologic impurities (residual Host Cell Protein, Host Cell DNA, RNase, DNase, Benzonase, Gentamicin, FBS, Trypsin, TrypLE, Glycerol)
  • Elemental impurities
  • Ion analysis
  • Process impurities (qNMR; QQQ;qTOF; LC-MS; LC-UV, FLD, CAD, ELSD, RID; GC-FID/MSD
    (residual solvents and volatiles)

Safety

  • Microbiology
  • Bioburden
  • Endotoxin (LAL)
  • Extractable and leachables

Biopharmaceutical tools:

qPCR

  • Quant Studio 5 hardware and software

Next Generation Sequencing

  • Illumina MiSeq NGS

Other Instrumentation/Capabilities

  • Automated DNA/RNA purification (KingFisher Flex)
  • HIAC particle counter (PharmSpec)
  • Nanoparticle size analysis (NanoSight NS300)
  • Tecan Evo 100 liquid handler
  • ICH stability storage and photostability
  • NMR spectroscopy
  • GC-FID/MSD (residual solvents and volatiles)

Imaging Systems and Plate Readers (UV and FLD)

  • BioRad ChemiDoc MP (Epi-fluorescent capable, Image Lab Secure)
  • SpectraMax M2 with Pro 7 software
  • SpectraMax M3 with Pro 7 software

Bioseparations

  • CE and cIEF
  • RP-HPLC
  • SEC-UV-RID-MALS
  • SDS-PAGE
  • UV-VIS
  • UPLC-qTOF
  • UPLC-QQQ
  • UPLC-UV/FLD

Common biopharmaceutical quality attributes:

Titer/Potency

  • Plaque assay
  • Impedance assay
  • ELISA

Host Cell DNA

  • E.coli, CHO, Vero, CV-1, etc.

Host Cell Protein

  • E.coli, CHO, Vero, CV-1, etc.
  • Partner with Cygnus for coverage analysis
  • Antibody Affinity Extraction (AAE)

Impurities analysis by ELISA or plate-based methods

  • Benzonase
  • FBS
  • Glycerol
  • Endotoxin
  • Exotoxin A
  • Total DNA
  • Total protein

Particulate Analysis

  • USP <787>, <788> (subvisible)
  • Nanosight NS300 (30-1000 nm, most viruses)

Osmolality, pH, Conductivity, Ion Analysis, Purity/Impurity and specialty instrumentation

  • LC-UV, FLD, CAD, ELSD, RID
  • CE-UV-FLD, cIEF, CZE, CE-SDS
  • qNMR
  • LC-QQQ
  • LC-qTOF
  • LC-MS
  • GC-FID/MSD (residual solvents and volatiles)
  • SDS-PAGE
  • NGS

Safety QC

  • Microbiology
  • Bioburden
  • Endotoxin

Quality assurance:

Expert team covering data review, document control, compliance, and quality. Collaborative problem solving. Quality Programme designed for compliance with:

  • 21 CFR Parts 210 and 211
  • ICH Q2
  • ICH Q6b
  • ICH Q7
  • ICH Q10

Quality Programme consists of:

  • Controlled document system (MasterControl)
  • Deviation/CAPA
  • Change control
  • OOS
  • Training
  • Vendor Qualification
  • Internal Audits
  • Data Review
  • Material Handling

Get in touch with Cambrex

If you’d like further information about the services available with Cambrex, don’t hesitate to get in touch.

Contact Us