Comprehensive Analytical Testing & Development
Advance your biotherapeutic entities by partnering with our team to develop stage appropriate analytical methods. We secure your downstream testing success with our precise Quality by Design (QbD) approach, in-depth understanding of macromolecule physicochemical properties, and state of the art analytical instrumentation and columns.
After establishing method feasibility, our team optimizes the process to ensure appropriate resolution and achievable detection limits. Before testing begins, we also determine linearity, precision, accuracy, and specific method development to anticipate acceptance criteria and pre-validation method performance.
From the first step to the last, we provide the analytical implementation needed to advance your biologic with confidence.
Drug Substance & Drug Product Methods
Our biotherapeutic method development process includes rigorous separation and quantitation, powered by chromatographic, electrophoretic, spectroscopic, and thermal instrumentation. These analytical methods are developed for effective characterization and release, with the goal of cultivating stability-indicating formulation and process development programs. The developed analytical assessments can be applied to the following applications:
- Identity
- Assay/Potency
- Purity/Impurity
- Excipient Quantitation
- Cleaning Validation Analysis
- Residual/Impurities Testing
- Leachables
Methods for All Biologics
Our analytical development capabilities cover a variety of analytical assessments to tackle any potential biotherapeutic modalities, including novel molecules and novel assay development. We have experience completing an extensive array of method development and implementation for assays, including:
- Antibodies
- Antibody-Drug Conjugates
- Fusion Proteins
- Polymer Conjugates
- Oligo Conjugates
- Therapeutic Enzymes
- Structural Proteins
- Peptides
- Viral Capsids & Virus-Like Proteins
- Vaccines
- Encapsulated Proteins
Analytical Methods
- Reversed Phase, IP-RP, HIC, HILIC
- Ion Exchange (IEX), Mixed Mode
- Size-Exclusion Chromatography (SEC), AF4 – High Molecular Weight Species
- Field Flow Fractionation
- UV, FLR, ELSD, CAD
- RI, MALS
- MS (Triple Quad and High Res)
- Capillary Electrophoresis: PA800 (CE-SDS/CZE/cIEF), Maurice (icIEF, iCGE), Bioanalyzer
- Lab Chip
- Fragment Analyzer
- Agarose/SDS-PAGE
- Intact Top-Down, Middle-Down Mass Analysis
- Bottom-Up Peptide Mapping
- Chemical & Post-Translational Modifications
- Conjugation Site & DAR
- Disulfide Bond Mapping
- Glycosylation (N- and O-linked)
- Carbohydrate Analysis (Released Glycans, Monosaccharides, Sialic Acid)
- Identification of Process Impurities & Related Substances
- HCP Identification
- Bioanalytical Quantitation
- UPLC/HPLC with Triple Quad, Q-TOF & Orbitrap detectors
- GC-MS with Headspace & FID for Residual Solvents & Impurities
- Near UV & Far UV Circular Dichroism for Higher Order Structure
- UV-VIS Spectrophotometers
- Spectrofluorometer
- ELISA
- Tm & Tonset by DSC
- Tm & Tonset by DSF
- Tagg by DLS
- SEC-UV/FLR, SEC-MALS, AF4-MALS
- Dynamic Light Scattering (DLS)
- Diffusion Interaction Parameter (kD)
- Nanoparticle Tracking Analysis (NTA)
- AC-SINS
- Nanoparticle Tracking Analysis (NTA)
- Micro Flow Imaging (MFI)
- Light Obscuration by HIAC
- Light Microscopy
Integrated Laboratory Services
Our experienced scientists, trained experts, and state-of-the-art facilities are standing by with CDMO support. Ready to add power to your project?