CMC Analytical Services for Biologics, ADCs, and CGT

CMC Analytical Services for Biologics, ADCs, and CGT
Product Description

Crystal Bio Solutions operates a 5,300 sq ft CMC analytical lab in New Jersey that supports programs from discovery through IND and BLA. We develop, qualify, and validate phase-appropriate methods and deliver inspection-ready data packages. Modalities include monoclonal and bispecific antibodies, proteins, ADCs, mRNA and LNP, and nucleotides.

Crystal Pharmatech

  • Country/Region:
    China
  • On CPHI since:
    2024
  • Certificates:
    2

Crystal Pharmatech

  • Country/Region:
    China
  • On CPHI since:
    2024
  • Certificates:
    2

More Products from Crystal Pharmatech (4)

  • Bioanalysis and Biomarker Services

    Product Bioanalysis and Biomarker Services

    Crystal Bio Solutions provides end-to-end bioanalytical and biomarker support for biologics, ADCs, and CGT. Our GLP compliant laboratories and senior scientists design, develop, qualify, and validate assays that stand up to FDA, EMA, and NMPA review. We cover immunogenicity and neutrality risk, PK and PD, ...
  • Integrated Formulation Development, GMP Manufacturing & Global Delivery

    Product Integrated Formulation Development, GMP Manufacturing & Global Delivery

    Crystal Pharmatech provides end-to-end oral solid dose development, injectable, lipid-based formulation development, and clinical manufacturing under one roof—seamlessly uniting enabling technologies for insoluble drugs (spray-dried ASDs, hot-melt extrusion, lipid and nano platforms) with conventional and ...
  • Integrated Small Molecule CRO Platforms

    Product Integrated Small Molecule CRO Platforms

    This service unifies material-sparing FAST analytics, solid-state research, lab-scale crystallization development, and pre-formulation into a single early-development track that turns scarce API into decision-ready insight and scale-transferable processes. We start with focused solid-state testing to revea...
  • Mol2Med™ Developability Assessment

    Product Mol2Med™ Developability Assessment

    Mol2Med is a modular, material-sparing path that integrates experimental testing, PBPK modeling, and form selection from API profiling through preclinical formulation design. Selected for first-time-right decisions on aggressive timelines, it can deliver go/no-go answers in ≤4 weeks with ≥500 mg API while ...

Crystal Pharmatech resources (2)