Biologics CMC Analytical Services - Crystal Pharmatech Co., Ltd.

Providing advanced Biologics Analytical Services, facilitating the progression of your biologics fro

Biologics CMC Analytical Lab, 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 a broad range of therapeutic modalities including antibodies, bi/multi-specifics, proteins, ADCs, mRNA, LNP, and nucleotides, supporting projects from discovery to the clinic.

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.

Biologics CMC Analytical Services Service Area

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Advanced Biologics Analytical Services

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High-Resolution Mass Spectrometry

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Bioanalysis and Biomarker Services

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Bio Analytics

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Developability Assessment, Pre-formulation Study for IND Enabling

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Product Quality Analysis

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Additional Capabilities

CMC: Experts in BLA filings for drugs at biophysical/chemical section using LC-MS under regulatory guideline for drug approval with several large pharma
Preclinical: Experts in candidate characterization, accelerated stability, 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

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

High-sensitivity, high-accuracy quantitative analysis to support bioactivity, PK/PD, bio-contaminants, safety testing

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

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

Versatile with flexible adoption of existing methods to address different modalities such as ADC with novel conjugated combinations, mRNA & LNP
Strong troubleshooting skills in resolving challenging analytical issues and addressing complex modalities