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Advanced Therapy Commercialization Hub

Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing in an integrated, innovation-rich environment that exceeds the value proposition offered by traditional CDMO and PDMO contract models.

Advanced Therapies Discovery and Characterization

The R&D team at A-DOC comprises 25 scientists with broad backgrounds and expertise in advanced therapies’ discovery, characterization, and optimized scale-up.  Experts with experience bringing cell and gene therapy candidates from discovery to IND submission address every client challenge cross-functionally.  

  • Engineering of therapeutic proteins and protein-based tools
  • Designing viral vectors
  • Non-viral gene editing and payload development
  • Functional and phenotypic characterization
  • Identification of tumor antigens
  • T-cell and T-cell receptor biology
  • Identification and verification of edits to T-cells
  • Immune Monitoring
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Preclinical CRO Services

AmplifyBio brings decades of experience to deliver industry-leading preclinical toxicology, safety, and pharmacology testing in an agile environment with high-level analytics capabilities to serve the dynamic safety needs of advanced therapy development. Whether for a single study, or a complete IND enabling program, we have the expertise to design safety, efficacy, or toxicology testing in all common species and models.  Lean on our experience across multiple species to assist you in devising the most appropriate study strategy. Immunodeficientimmunocompromised and transgenic or other genetically modified animal models are also available.

Small Animal Models:
  • Rodents – mice, rats, guinea pigs, hamsters
  • Nonrodents – ferrets, rabbits
Large Animal Models:
  • Minipigs and pigs
  • Canine
  • Nonhuman primates

Analytics for Preclinical Studies

We have in vitro assay platforms and capabilities to complement in vivo work and support data-driven decision making to develop advanced therapies. Across the business, our experts in virology, immunology, and molecular biology, have access to the latest platforms and methods to ensure you have the analysis you depend on:

Immunological Testing
  • Immunophenotyping
  • Cellular immunity (T cells/ B Cells)
  • Complement activation
  • Antibodies and neutralization
  • Cytokine production
  • Immunoprofiling
Molecular Testing
  • Biodistribution and persistence
  • Genomic insertion assessments
  • Vector shedding
  • Next-generation sequencing
  • Gene expression profiling
  • Spatial gene expression

Advanced Therapy Manufacturing

Partnering with AmplifyBio for your manufacturing needs for cell therapy, gene therapy, mRNA, plasmid, or other complex supply chain components differs from a typical CDMO experience. Instead, drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.  Available in 3 collaborative, partner-driven staffing models: 

  • Hoteling Model
  • Hybrid SME+ Model
  • Full-Service Partner Model
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Contact Us

Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing available in an integrated, innovation-rich environment that goes beyond the value proposition offered by traditional CDMO and PDMO contract models.