Empower innovation with custom cell-based bioassays for ATMPs and biologics

Solvias provides leading end-to-end support for cell-based bioassays, ensuring precise, reliable, and efficient solutions for Advanced Therapy Medicinal Products (ATMPs) and biologics. With a proven track record in assay development, validation, and commercialization, we are your trusted partner in accelerating the journey from development to market.

Unique combination of benefits

  • Extensive experience across cell and gene therapies and biologics, with scalable workflows for both large-scale and niche projects.
  • Advanced potency, stability, and safety assessments precisely aligned with your product’s mechanism of action.
  • Tailored onboarding strategies and seamless assay transfer for rapid scaling across EU and US sites.
  • Demonstrated success in EMA and FDA audits, backed by GMP, GLP, and ISO9001 certifications.

Our proven track record

Solvias supports the commercial release of four ATMPs and two biologics with tailored potency assays. Conducting over 3,800 GMP-compliant tests annually, we provide critical expertise for 40+ clinical-stage drugs.

Comprehensive service solutions

We specialize in cell-based bioassays for CGTs and biologics, offering end-to-end support from assay development to GMP-compliant release testing. Our services ensure precision, reliability, and regulatory compliance throughout your product’s journey.

Solvias develops bespoke assays tailored to your product’s specific needs, ensuring optimal performance through rigorous development, qualification, and validation.

Our adaptable Quality Management System provides continuous support and reliability, customized to meet your unique requirements.

Our streamlined operations enable efficient and timely assay translation to GMP, simplifying your path to compliance.

We offer comprehensive qualification and validation services fully aligned with ICH Q2(R2), ICH Q14, and USP <1033/1210>, guaranteeing adherence to the highest industry standards.

Our flexible footprint enables rapid scale-up to meet your evolving clinical and commercial needs with agility and precision.

We provide robust testing solutions for clinical and commercial-stage products, ensuring unwavering quality and consistency at every step.

We deliver reliable testing to support product release and long-term stability studies, ensuring consistency throughout the product lifecycle.

Our comprehensive safety profiling meets stringent regulatory standards, safeguarding quality and compliance.

Extensive expertise across modalities

Our cell-based bioassay services are tailored to the specific needs of diverse therapeutic modalities.

Biologics

  • Binding assay
  • Immune checkpoint reporter assay
  • Antibody-dependent cellular cytotoxicity (ADCC) assay
  • Tumor growth/inhibition assay
  • Surrogate reporter assay
  • Antibody-drug conjugate cytotoxicity assay

Cell & Gene Therapies

  • Target-specific activation assay
  • Proliferation cytotoxicity assay
  • Safety cytokine independent growth (SCIG) assay
  • Gene expression assay
  • Colony-forming unit (CFU) assay
  • Specific targeted gene potency assay

Versatile assay solutions

Evaluate therapeutic strength to ensure intended biological activity. View our blog on potency assays.

Assess potential immune responses, including anti-drug antibodies and cytokine production.

Identify whether a molecule is recognized as an antigen by the immune system.

Characterize the biological activity of your therapy.

Determine the biological pathways or processes a therapy engages to achieve its effect.

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Advanced analytical capabilities

Flow cytometry, qPCR, (electro)chemiluminescence, fluorescence, absorbance, LC-MS, capillary electrophoresis, ELISA, and molecular-based techniques with state-of-the-art equipment including:

  • SpectraMax M6
  • Amnis® Imaging Flow Cytometer
  • PA800 Plus Capillary Electrophoresis
  • Hamilton Robotics Microlab
  • FACSLyric™ (Clinical Cell Analyzer)
  • BioTek Synergy Microplate Reader
  • Q Exactive™ Plus Orbitrap
  • MACSQuant® Analyzer 16

Contact us for a complimentary consultation