Crystal Bio, the biologics analytical division of Crystal Pharmatech, operates a cutting-edge 5,300 sq.ft lab in New Jersey. We provide advanced analytical services for biotech and pharma companies developing biologics. Our expertise spans antibodies, proteins, ADCs, mRNA, LNP, and nucleotides, supporting projects from discovery to clinical stages.
.png "Crystal_Bio_(4).png")
High-Resolution Mass Spectrometry
Large and small molecule analysis and quantitation
Intact and full sequence mapping including PTM, glycosylation, and sequence variant analysis
Product Quality Analysis
Higher Order Structure and Disulfide Mapping Analysis by LC-MS, SEC-MS/ MALS, FT-IR, UV CD, FL, nano DSC, DLS, and AUC
Structure and Structure-Function Analysis by LC-MS, SEC, IEX, CE, icIEF, UV, RPLC/HIC, and ELISA/Binding
Process Impurity Analysis
HCP and Residual Protein A Analysis by LC-MS/ELISA/Binding including unconjugated ligand/Ab and linker-payload analysis for ADCs
Additional Capabilities
Serum Stability, protein expression, and PK/PD analysis by LC-MS or ELISA including ADC with novel conjugated combinations, and mRNA & LNP analysis with our strategic partner- CATUG
Safety Testing
Bioburden, Endotoxin, Mycoplasma, Residual Host DNA, Residual Protein A, and HCP Analysis
Bioactivity
Effector function (ADCC& ADCP) and ligand binding analysis for potency and MOA
Sequence liability ID
Analytical and biophysical study
Accelerated stability assessment for candidate selection and pre-formulation
Stress studies to predict manufacturing process fit
Risk assessment for CMC success
Seamless transfer from Analytical Method Development to Tech Transfer to the QC lab
Providing Bridging studies between different equipment
Assisting with Regulatory submissions / comments
Providing support during testing of non-conforming Manufacturing batches
Deep Pharma and Biotech expertise
High-resolution Mass Spectrometry
Comprehensive knowledge
Fast, efficient timelines
Customized, phase-appropriate solutions
Adaptable and responsive approach
