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CMC Analytical Development and Testing Services



Crystal Bio Solutions operates a 5,300 sq ft CMC analytical lab in New Jersey that supports programs from discovery through clinical stages. We develop, validate and transfer various analytical methods for complex drug substances and drug products, deliver routine testing, execute stability studies and extended characterizations.


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Product Quality Analysis

Identity, purity, potency, and safety testing using orthogonal biophysical and biochemical methods. Techniques include SEC, IEX, RP, HIC, CE-SDS, DLS, DSC, UV, fluorescence, and FTIR for structure and structure-function characterization. High-Resolution Mass Spectrometry Intact mass, peptide mapping, PTM and glycan profiling, sequence coverage, and charge variant assessment. ADC specific support includes DAR determination and impurity profiling. Methods are suitable for characterization, release, and stability. Impurity Characterization

 Targeted assays for residuals and process impurities that affect product safety. Capabilities include host cell proteins and DNA, residual Protein A and detergents, residual solvents, endotoxin and bioburden. Results are delivered with clear acceptance criteria and trending. Bioactivity and Potency

Quantitative assays that link structure to function for PK and PD relevance. Options include cell-based potency, reporter and binding assays, and orthogonal readouts to confirm mechanism. Developability Assessment and Pre-formulation Stress screens, forced degradation, and excipient compatibility to understand aggregation, charge variants, and stability risks. We generate decision-ready reports and work packages for IND CMC sections. Advanced Solutions

Modality-specific solutions for XDC conjugate, peptide, ASO, siRNA, mRNA, LNP and AAV, rapid method troubleshooting for complex matrices, method transfer in and out, and phase-appropriate studies.
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3D illustration of a biologic protein complex binding to a target in a fluid environment, used to explain how biologics act on specific pathways and receptors. How Biologics Work and What Makes Them Unique Biologics are therapies produced in living systems that act on specific molecular pathways and receptors. In autoimmune disease, for example, certain biologics modulate or block immune signals to reduce tissue damage. Unlike small molecules, biologics are large, structurally complex, and often heterogeneous. They are sensitive to heat and shear, prone to degradation or aggregation, and require tight controls to prevent microbial contamination. These properties make specialized analytics, storage, and handling essential across development and manufacturing. Stylized Y-shaped antibody molecules floating in solution, illustrating monoclonal antibody structure and biologics modality concepts. How Biologics Are Approved by the FDA In the United States, most biologics are reviewed by the FDA’s Center for Biologics Evaluation and Research. Sponsors open an IND to begin clinical studies, then progress through Phase 1 safety, Phase 2 dose and efficacy exploration, and Phase 3 confirmatory trials. Approval requires a Biologics License Application that integrates quality, nonclinical, and clinical evidence. Topics such as GMP compliance, comparability after process changes, device or combination product considerations, and pharmacovigilance plans are assessed before marketing authorization is granted. Concept image of a transparent capsule containing a DNA double helix, representing gene and cell therapy programs and nucleic acid modalities. Categories of Biologics and Their Applications
  • Recombinant proteins such as enzymes, hormones, and growth factors
  • Monoclonal antibodies for autoimmune and oncology indications
  • Bispecific and multispecific antibodies that engage multiple targets or cells
  • Antibody-drug conjugates that deliver cytotoxic payloads with targeted specificity
  • Fusion proteins and Fc-engineered formats designed for extended half-life or function
  • Gene and cell therapies including using viral or non-viral delivery
  • Oligonucleotide therapies such as siRNA and antisense
  • mRNA vaccines and theraputics with LNP delivery

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