Crystal Bio - Crystal Pharmatech Co., Ltd.

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.

How do Biologics work and Why are they unique?

Biologics are being used as drugs to treat a variety of human and animal diseases including autoimmune diseases such as rheumatoid arthritis. In the case of autoimmune diseases, some biologics interrupt signals, and pathways in the immune system to reduce the damage inflicted by the autoimmune conditions. Biologics can be very micro-heterogenous mixtures of structural variants that are difficult to identify and characterize. Biological products are generally heat sensitive and susceptible to microbial contamination.

How are Biologics approved by FDA?

Biologics also referred to as Biopharmaceuticals, and are regulated in USA by the Center for Biologics Evaluation and Research (CBER) division of FDA. These biologics need to go through different clinical phases (I, II, and III) of drug development followed by the Biologics Licensing Application (BLA) process for approval by FDA prior to commercialization and marketing.

Categories of Biologics and their applications

Some of the general categories of biologics include:

Vaccines (used for disease prevention)
Recombinant proteins (such as insulin or erythropoietin)
Interleukins (immune molecules that can be used to treat certain infections and cancers)
Monoclonal antibodies (like those used to treat autoimmune diseases and cancer)
Bispecific antibodies (next generation strategy for antibodies-to target human diseases such as cancer immunotherapy)
Stem cell therapies (to treat human diseases such as certain cancers or genetic diseases)
Other cell therapies (like Chimeric Antigen Receptor T cells used to treat cancer)
Gene therapies (to treat disease such as those for genetic conditions), etc.

Crystal Bio Service Area

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Crystal Bio Core Services

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Analytics

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Bio Analytics

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Developability Assessment

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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

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