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.
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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
Extended package to GMP and beyond
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.
CMC: Experts in BLA filings for drugs at biophysical/chemical section using LC-MS under regulatory guideline for drug approval with several large pharma including Celgene/BMS and Acceleron/Merck.
Preclinical: Experts in serum stability and in-vivo CQA analysis to assure drug candidate selection in pre-clinical stage.
Small Molecule: Leveraging Crystal Pharmatech’s established expertise in small molecule drug substance and drug product analysis, employing high-resolution MS for characterization and quantitation of small molecules.
With a deep understanding of the latest regulatory developments, we can help our customers meet the regulatory requirements for authorization in all global regions, providing regulatory compliant data. Our experts will ensure the data meets the requirements of current Good Manufacturing Practice (cGMP), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), OECD GLP and other regulatory standards for investigational new drug application (IND) or new drug application (NDA) or biologics license application (BLA).
Capable of utilizing both analytical and bio-analytical tools to address residual chemical, formulation components stability, bacterial/virus, or protein-related compounds for safety concerns, with rational selection of reliable assays under regulatory guideline as going forward.
Versatile with flexible adoption of existing methods to address different modalities such as ADC with novel conjugated combinations, mRNA & LNP, and related PK/PD or protein expression analysis.
