Solvias Research Triangle Park, NC, USA

Phase 2:

The second phase will open in July 2025 and will add 30,000 sq. ft. of advanced laboratory space, significantly broadening our service portfolio to include:

Microbiology: Featuring rapid sterility testing and other microbiological services.
Molecular Biology: Enhanced capabilities with automation for faster and more efficient workflows.
Virology: Comprehensive viral testing services to support biologics and advanced therapies.
Transmission Electron Microscopy (TEM): Providing high-resolution imaging for in-depth structural analysis.
Lentivirus Suite: Dedicated facilities for the safe and efficient handling of lentiviral vectors.

Cell-Based Bioassays

From day one, Solvias' RTP Center of Excellence will focus on one of the most critical challenges in CGT: developing robust cell-based bioassays.

Applications

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
Programed 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

Cell Banking

We work with customer-supplied research cells, culturing and preparing Master Cell Banks (MCB) and Working Cell Banks (WCB). The MCB is cryopreserved after thorough characterization and testing for purity, identity, and stability, serving as a reliable primary source for future use. With our Thaw-and-Go solution, these pre-optimized frozen cell banks are ready for immediate use in assays without the need for recovery or additional preparation, reducing turnaround times and ensuring consistent, reproducible results across experiments.

Analytical Chemistry

At RTP, we complement our bioassay services with advanced analytical chemistry capabilities, including USP compendial methods and characterization services.

Osmolarity
pH
Turbidity
Particle size
USP certificates for particle sizes

Technology

HIAC
CE - Maurice
HPLC - Agilent 1260 w/ FLD & DAD
HPLC - Agilent 1290 w/ UV & FLD
SCIEX - PA 800 + CE-SDS, CGE & IVTRNA

One of the first services we will be offering at our new center of excellence is cell-based bioassay (CBBA), offering tailored, phase-appropriate solutions that streamline drug development and help mitigate risks early on. We invite you to watch our webinar, in which Jung-Hua YEH, PhD, Principal Scientist, and Reginald Clayton, PhD, Head of Biosafety and Deputy Site Head, will delve into CBBA method selection for different modalities, with a focus on potency, and common pitfalls in assay development.

Press Release

Solvias to Build Biologics and Cell & Gene Therapy Testing Center in Research Triangle Park

NCBiotech

Solvias builds NC HQ for biologics, cell and gene therapy testing

Contract Pharma

Solvias Announces New Biotech Site in North Carolina

BioProcess International

Solvias breaks ground on NC cell therapy plant

Potency assays are critical for licensing and releasing biologics and cell & gene therapy products, but their complexity and variability pose significant challenges. The diverse nature of indications, and drug modalities of cell and gene therapies (CGTs) often leads to bespoke assays developed de novo for each specific ATMP. In this context, inherent variability of results, sample volume, drug stability and testing time constraints, as well as a need for strategic testing approaches to assess complex mechanisms of action provide significant challenges for manufacturers and CMC testing labs.

Discover how to navigate these challenges with our white paper, "The Potency Puzzle: Overcoming Challenges in Potency Assays for Cell and Gene Therapy Development."

“The Solvias team's expertise in genomic characterization has helped us establish the assays needed for each of our CRISPR genome-edited CAR-T cell therapies.”

Scott Gradia, PhD

VP of Platform Research, Caribou Biosciences

“The scientific delivery of this quality work from the Solvias team exceeded industry standards. The team are masters of their craft.”

Doug Daniels

Sr. Director of QC, Veloxis Pharmaceuticals

“The drug delivery and physical characterization team provided outstanding support to fine tune analytical methods, perform product specific characterization studies and to complete in vitro BE studies required for product filing at the US FDA.”

Clarissa Gobetti, PhD

CSO, Phargentis

Alongside our Cell and Gene Therapies capabilities, we offer a wide array of analytical solutions for drug products and delivery devices, including solid state development, extractables & leachables analysis, and biopharmaceutical studies. Choose Solvias for comprehensive support and expertise in bringing your products to market with confidence. Get in touch with us today to explore how we can support your goals. Whether you're seeking advice, have a project in mind, or need insights tailored to your challenges, our team is here to listen and assist.

Expanding into North America

Solvias Cell and Gene Therapy Center of Excellence in North Carolina

Our Cell & Gene Therapies Hub in the US

Building on decades of expertise developed in Europe, creating a global network of world-class testing capabilities

Phase 1:

Phase 2:

Cell-Based Bioassays

Applications

Assay Types

Detection Methods

Cell Banking

Analytical Chemistry

Technology

Now Open

Solvias Cell and Gene Therapy Center of Excellence in North Carolina

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