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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

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Crystal Bio Core Services

Analytics
Bio Analytics
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 CATUG partner particularly in mRNA purity, capping %, dsRNA amount, size/PDI, and EE%

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.

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.

  • 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.

Product Quality Analysis

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).

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.

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
U.S
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
Canada
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
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