What types of bioanalytical methods does ProBio offer?

ProBio offers a wide range of bioanalytical methods including ELISA-based assays, FACS testing, pathology testing (IHC, HE staining, multi-IF), and molecular testing (Sanger sequencing, Q-PCR, RNAscope).[reference:15]

Does ProBio support regulatory submissions with bioanalytical data?

Yes. ProBio provides bioanalytical method development and validation services aligned with regulatory expectations, supporting PK/ADA analysis and other studies required for IND and BLA filings.[reference:16]

What is ProBio's experience in bioanalytical services?

ProBio has developed over 50 bioanalytical methods and supported over 200 NME programs, with high-throughput screening capacity up to 10,000 samples.[reference:17]

Bioanalytical Development

Integrated protein characterization, bioactivity assessment, and analytical method development to support from early development to commercialization.

Overview

Workflow

Case Studies

Related Services

FAQs

Support for IND-Enabling Characterization Studies

Structure-to-Function Insights

Protein and antibody characterization
Bioactivity and MOA assessment
CQA evaluation

Advanced Bioassay Expertise

Binding affinity and kinetics
ADCC, CDC, and ADCP assays
Customized cell-based functional assays

Regulatory-Ready Characterization

IND-supporting analytical packages
Comparability and stability studies
ICH-aligned analytical methodologies

Expertise in Complex Biologics

Bispecific and multispecific antibodies
Recombinant proteins
Antibody fragments and engineered formats

Advanced Analytical Technologies Under One Roof

Comprehensive Analytical Characterization

General properties: UV280, pH, osmolality, color, clarity
Structural characterization: LC-MS, CD, DSC, DLS, glycan analysis
Product-related substances/impurities: SEC, CE, HIC, RP-HPLC, CE-SDS, icIEF
Process-related impurities: HCP, HCDNA, Protein A, endotoxin, bioburden
Bioassays: ELISA, HTRF, cell-based assays, Fc-binding assays
Further details in the table below:

Strong Bioanalytical Capability

Platform analytical methods for proteins and bispecific antibodies
Dedicated assay and assay cell line development capabilities
Early-stage method development to accelerate programs
Method development, optimization, qualification, and validation
Aligned with ICH, USP, and Ph. Eur. Expectations
Further details in the table below:

Expertise in Complex Biologics

Symmetric bsAbs: IgG-VHH, IgG-scFv, IgG-protein, IgG-peptide
Asymmetric bsAbs: scFv-Fab, KIH, DuoBody, Fab/scFv-Fc, trispecific antibodies
Protein modalities: VHH, Fab, scFv, cytokines, enzymes, coagulation factors, protein complexes, vaccine antigens
Extensive experience with antibody fragments and engineered biologics