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Expanding into North America

Solvias Biologics and Novel Modalities Center of Excellence in North Carolina

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Backed by a proven track record of supporting developers of advanced modalities across the full product lifecycle in Europe, Solvias is extending its expertise to meet the growing demand for GMP testing services in the U.S.

Our newest facility in Research Triangle Park, North Carolina, offers comprehensive support for biologics, cell therapies, gene therapies, and other novel modalities —from preclinical development through commercial release.

See Press Release

Our Biologics & Novel Modalities Hub in the US

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

We deliver a comprehensive portfolio of analytical services across therapeutic modalities and delivery systems, offering phase-appropriate solutions that streamline drug development and mitigate risks early on.​

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mRNA & Lipid Nanoparticles

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Peptides & Oligos

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Plasmids & Recombinant Protein

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CRISPR

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ADCs & mAbs

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AAV & Lentivirus

Cell-Based Bioassays & Compendial Methods

Our RTP Center of Excellence is purpose-built to help clients overcome one of the most critical challenges in cell and gene therapy: developing robust cell-based bioassays.

  • Potency Testing
  • Immunogenicity Studies
  • Antigenicity Studies
  • Function Studies
  • Mechanism of Action Studies
  • Binding Assays
  • Programed Cell Death
  • Gene Expression
  • Cell Proliferation
  • Cell Signaling Assays
  • Reporter Assays
  • ELISA – UV vis, fluorescence, ultra-sensitive luminescence
  • AlphaLISA
  • Flow Cytometry – FACS Lyric
  • Electrochemiluminescence – MSD
  • Capillary Electrophoresis – Maurice CE

 

  • Osmolarity (Ph.Eur. 2.2.35 USP<785>)
  • Turbidity (Ph.Eur. 2.2.1; USP<855>)
  • pH (Ph.Eur. 2.2.3; USP<791>)
  • Extractable Volume (Ph.Eur. 2.9.17 USP<697/698>)
  • Visible Particles (Ph.Eur. 2.9.20; USP<790>)
  • Container Closure Integrity (dye ingress USP<1207>)
  • Subvisible Particles (Ph.Eur. 2.9.19 USP<787/788>)
  • Degree of Coloration (Ph.Eur. 2.2.2; USP<691>)

 

  • Agilent 1260 HPLCw/ FLD & DAD
  • Agilent 1290 HPLCw/ UV & FLD
  • MACSQuant® Analyzer16 Flow Cytometer
  • Orbitrap Exploris 240 Mass Spectrometer and Vanquish LC
  • HIAC LiquidParticle Counter
  • Illumina MiSeqi100+ System
  • SCIEX PA 800+ CE-SDS, CGE, IVTRNA
  • Maurice CE
  • Maurice FlexcIEF & CE-SDS

 

From Vision to GMP-Ready in One Year

In roughly 12 months, we went from shell space to an operational laboratory to support complex therapies.

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  • Phase 1: 20,000 sq ft with 6 cell-based bioassay suites & biophysical analytics labs, opened in January 2025.

  • Phase 2: 30,000 sq ft with the addition of molecular biology, virology and microbiology suites​, opened in July 2025.

Behind the Build: Lab Design Insights

Our Growth Is Making Headlines

From industry journals to business news outlets, the media is highlighting Solvias’ expansion into the U.S. and the impact of our new RTP facility on the future of biologics, cell, and gene therapies development.

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Press Release
Solvias to Build Biologics and Cell & Gene Therapy Testing Center in Research Triangle Park
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NCBiotech
Solvias builds NC HQ for biologics, cell and gene therapy testing
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Contract Pharma
Solvias Announces New Biotech Site in North Carolina
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BioProcess International
Solvias breaks ground on NC cell therapy plant
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Contract Pharma
Solvias CoE for Biologics & Novel Modalities Becomes cGMP Ready
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DCAT Value Chain Insights
Solvias Opens Center of Excellence for Biologics & New Modalities
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Discover Pharma
Solvias expands US cGMP testing capabilities with RTP center phase 2 build-out
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Manufacturing Chemist
Solvias expands US capabilities as RTP centre becomes cGMP-ready
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Pharma Source
Solvias Achieves cGMP Readiness at RTP Site, Expands US Analytical Capabilities
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LabDesign News
Solvias Expands into Cell and Gene Therapy with HQ in North Carolina
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Downloadable Resources: Cell-Based Bioassays

To help you navigate the complexities of potency testing, regulatory requirements, and assay development, we’ve assembled a collection of expert cell-based bioassay resources, including webinars, white papers, e-books, and case studies. Explore real-world insights, proven strategies, and practical guidance from Solvias scientists to accelerate your development and de-risk your programs.

Download the resources
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Our Customers

“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.”
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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

Join Our Team

As part of our dedicated team, you'll drive commercial success and scientific excellence, accelerating the journey of groundbreaking therapies to market.

Job Openings

Bring your innovation to its destination

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.