Center of Excellence for Advancing Biologics and Cell & Gene Therapy Testing

Solvias is proud to announce the opening of its newest facility in Research Triangle Park, North Carolina—a Center of Excellence for Biologics and Cell & Gene Therapy Testing. This expansion reinforces our commitment to GMP testing services across biologics, cell therapy, gene therapy, and other novel modalities. Our RTP facility integrates cutting-edge technology to accelerate service delivery, ensuring seamless support from preclinical development to commercial release.

Broad capabilities in Biologics & Cell & Gene Therapies

Solvias RTP specializes in advanced cell-based bioassays and compendial testing, offering tailored solutions to support clients at every stage of drug development.

Cell-based bioassays capabilities

Cell-based assays are essential for ensuring the quality, safety, and efficacy of biopharmaceutical products. They enable the validation of biosimilar comparability and ensure regulatory compliance.

cell-based bioassays

Cell banking capabilities

Our frozen cell bank solutions eliminate preparation time and variability, enabling immediate assay deployment. Services include Master Cell Bank (MCB) Creation and Working Cell Bank (WCB) Creation.

 

cell banking

Analytical Chemistry & Compendial Testing

Solvias RTP offers USP compendial methods and analytical chemistry solutions to support bioassay services, ensuring compliance with global pharmacopeias.

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Top-notch applications, assay types, and detection methods

We offer integrated, tailored solutions to support your assay requirements:

  • Potency Testing: Determine the strength or activity of a therapy to ensure it performs as intended
  • Immunogenicity Studies: Determine whether a therapy induces an immune response (e.g., anti-drug antibodies or cytokine production).
  • Antigenicity Studies: Determine whether a molecule is recognized as an antigen by the immune system.
  • Function Studies: Determine the specific biological activity of a therapy
  • Mechanism of Action Studies: Determine the biological pathways or processes a therapy engages to achieve its effect.
  • Assay Types: Binding Assays, Programmed Cell Death, Gene Expression, Cell Proliferation, Cell Signaling Assays, Reporter Assays
  • Detection Methods: ELISA – UV vis, fluorescence, ultra-sensitive luminescence, AlphaLISA, Flow Cytometry – FACS Lyric, Electrochemiluminescence – MSD, Capillary Electrophoresis – Maurice CE
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Accelerate Your Drug Development with Solvias

At Solvias RTP, we are your trusted analytical partner from preclinical development to commercial success. Whether you need assay development, validation, or GMP testing, our global network and expertise mitigate risk while ensuring regulatory excellence.

Performing small molecule analysis

Quality you can trust

Solvias maintains an impeccable quality record with rigorous regulatory compliance and customer satisfaction:

0 Critical Findings in 2023
100+ Customer Audits Annually
Successful FDA & Swissmedic Inspections
ISO 17025 Certification

LEARN MORE ABOUT QUALITY & REGULATORY

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Contact us for a complimentary consultation