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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Characterization of biologics plays an important role in their development as human therapeutics. As per FDA, EU, ICH Q6B and other regulatory guidelines, development of biopharmaceutical products requires providing sufficient Chemistry, Manufacturing and Controls (CMC) information of both Drug Substance (DS) and Drug Product (DP). Following are the hightlights of our services on characterization of biologics:
Analysis of Proteins
Structural Analysis Including Higher Order Structure Analysis
Analysis and Characterization of Post-Translational Modifications
Impurities Analysis
Degradation Studies
Biological Characterization
Comparability studies are important to ensure that a process change made during the process development and/or manufacturing will not have an adverse impact on the quality, safety and efficacy of biopharmaceuticals. Following are the highlights of our services for comparability studies:
Primary Amino Acid Sequencing
Intact & Reduced Mass Analysis
N- & C-terminal Sequence Analysis
Higher Order Structure Analysis
Biological Activity/Potency
Other Post-Translational Modifications
Well-developed analytical methods are required, to test quality attributes such as identity, strength, purity and potency of biomolecules. There are two broad categories of analytical methods and these are listed below:
Compendial Methods
Non-Compendial Methods
The Impurities should be quantified, characterized and their impact on the biological activities of the products should be evaluated according to ICH Q6B guidelines. There are four different categories of impurities:
Process-Related Impurities (cell substrates derived, cell-culture derived, downstream-derivde, etc.)
Product-Related Impurities(N- and C-terminal modifications, oxidation, deamidation, glycation, aggregation, etc.)
A manufacturer developing biosimilar products must show that the biosimilar product is highly similar to the innovator product by extensively characterizing the structure, function and bioactivity in relation to the reference standard, innovator product and biosimilar product. We provide the following services for biosimilar analysis:
Comparability Studies
Similarity Studies
Stability Studies
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.
