MAMMALIAN PROTEIN ANALYTICAL SERVICES
Extensive analytical experience comes standard.
Our team offers extensive experience in transferring, developing, qualifying, and validating analytical assays.
Offering tailored solutions to meet our clients’ unique needs.
Our analytical team adapts its services for projects at any stage. With flexible, cost-effective methods, we help complex molecules reach the market faster while ensuring clear deliverables and seamless communication. Our multidisciplinary analytical experts will design an agile analytical program that will adequately characterize your product to meet phase-appropriate regulatory guidelines, from early-phase to commercial.
-
Analytical Instrumentation
-
Assays for Upstream and Downstream PD Support
-
Assays for IND/BLA Support
-
Assays for Commercial QC Release
- Waters Alliance HPLCs
- Waters Acquity/Arc UPLCs
- Agilent 1100 HPLCs
- Protein Simple iCE3
- AB Sciex PA800+
- Molecular Devices Plate Readers
- Biotek Plate Readers
- C Technologies SoloVPE
- Thermo Evolution UV Instruments
- Thermo LTQ-Orbitrap XL Mass Spec
- qPCR Thermo ABI 7500 Fast
- Protein Quantitation, Titer Assay and A280 Quantitation
- Impurity Clearance — HCP, DNA, Protein A, etc.
- Charge Variant Analysis by cIEF & CE
- Aggregate Analysis by SEC-HPLC
- Glycan/Sialic Acid Variants
- Process/Product Characterization Assays
- Sequence Variants and Micro-Heterogeneity
- Impurity Characterization
- Integrated Development/Optimization Support
- Characterization/Investigational Testing
- Method Transfer and Phase-Specific Validation Support
- Protein Sequence, PTM, Disulfide Bond, and Peptide Map
- Biophysical Characterization by HPLC/UPLC, CE, and iCE3
- Glycan and Sialic Acid Analysis SDS-PAGE Analysis
- Extractable and Leachable Testing
- Cell-Based Potency Assays Offered Through External Partners
- CD, FL, DSC, and DLS/MALS
- BLI or Biacore and NMR (1D, 2D)
- AUC, FFF
- 2D HCP Coverage Analysis
- CGMP Lot Release Testing
- CGMP Stability Testing (ICH, WHO, EMA)
- CGMP In-Process QC Testing
- Process Validation Support
- Process Impurity Testing — Residual HCP, DNA, Protein A, etc.
- Bio-Similarity Testing
Analytical Instrumentation
- Waters Alliance HPLCs
- Waters Acquity/Arc UPLCs
- Agilent 1100 HPLCs
- Protein Simple iCE3
- AB Sciex PA800+
- Molecular Devices Plate Readers
- Biotek Plate Readers
- C Technologies SoloVPE
- Thermo Evolution UV Instruments
- Thermo LTQ-Orbitrap XL Mass Spec
- qPCR Thermo ABI 7500 Fast
Assays for Upstream and Downstream PD Support
- Protein Quantitation, Titer Assay and A280 Quantitation
- Impurity Clearance — HCP, DNA, Protein A, etc.
- Charge Variant Analysis by cIEF & CE
- Aggregate Analysis by SEC-HPLC
- Glycan/Sialic Acid Variants
- Process/Product Characterization Assays
- Sequence Variants and Micro-Heterogeneity
- Impurity Characterization
Assays for IND/BLA Support
- Integrated Development/Optimization Support
- Characterization/Investigational Testing
- Method Transfer and Phase-Specific Validation Support
- Protein Sequence, PTM, Disulfide Bond, and Peptide Map
- Biophysical Characterization by HPLC/UPLC, CE, and iCE3
- Glycan and Sialic Acid Analysis SDS-PAGE Analysis
- Extractable and Leachable Testing
- Cell-Based Potency Assays Offered Through External Partners
- CD, FL, DSC, and DLS/MALS
- BLI or Biacore and NMR (1D, 2D)
- AUC, FFF
- 2D HCP Coverage Analysis
Assays for Commercial QC Release
- CGMP Lot Release Testing
- CGMP Stability Testing (ICH, WHO, EMA)
- CGMP In-Process QC Testing
- Process Validation Support
- Process Impurity Testing — Residual HCP, DNA, Protein A, etc.
- Bio-Similarity Testing
What makes our analytical services stand out?
Flexibility to handle both small and large-scale projects.
Our experienced team is able to adapt rapidly to changing project deliverables and metrics.
Extensive CGMP quality and compliance track record.
We remain committed to flexibility, collaboration, and innovation.
History of successful analytical programs.
Our robust and scalable processes are based on insights gained from our advanced biophysical protein characterization methodologies.
