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Crystal Bio Overview

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.

Crystal Bio Overview

Crystal Bio Service Area


Crystal Bio Core Services

Bio Analytics
Developability Assessment
Extended package to GMP and beyond

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


  • 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

Competitive Advantages

High-resolution Mass Spectrometry
  • 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.

  • Clinical: Extensive experience in gap analysis of CMC issues related to clinical development.

Product Quality Analysis

Rationally combined both analytical with various biophysical/chemical tools and bio-analytical with various bioassay tools for structure and structure-function characterization.

Process Impurity Analysis

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.

Developability Assessment, Pre-formulation Study for IND Enabling

Strategic designing and generating work package utilizing analytical and biophysical tools to study accelerated and stressed stability of lead candidate for risk assessment.

Additional Capabilities

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.

Contact Us
bd_global@crystalpharmatech.com +1-609-604-8303
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303