In the development of cell and gene therapy products, there is a critical data gap that exists between the discovery and development phases. Every day our understanding of the modalities of advanced therapies grows, and more precise and efficient technologies exist for characterizing these drugs and assessing their efficacy. AmplifyBio has acquired a new fully equipped site and has added significant drug development domain expertise to empower our preclinical CRO customers with a richer understanding of their drug candidates that allows them to anticipate and mitigate downstream failures. 

 

Amplify - DOC Cell and Gene Therapy Discovery Services

It is time to move past the idea that in the development and commercialization of cell and gene therapies ‘the process is the product.’ AmplifyBio aims to replace that saying with a new one: ‘the product is the product.‘  The addition of these capabilities to complement our in vivo preclinical work means that cell and gene therapies can now be differentiated based on safety and efficacy profiles and specific product characteristics, not development processes.

  • Single cell next-gen sequencing
  • Cloning and plasmid generation
  • Mutagenesis
  • Cell phenotyping by transcriptome
  • Cell engineering and vector design
  • Non-viral gene knock in and knock out
  • Recombinant protein design
  • Protein expression and purification 

Discovery, Optimization, and Characterization

  • Cell phenotyping by protein markers
  • Cell selection and sorting (FACS)
  • Cell expansion and differentiation
  • Cell activation and function 
  • Immunoassays
  • Spectroscopy
  • LC-MS
  • HPLC

Expertise and Common Applications

These capabilities were added through an asset acquisition of a site, platforms, and broad domain expertise from PACT Pharma. PACT is a clinical-stage company developing neoantigen-specific T cell receptor cell therapies. As a result of this deal, PACT will continue its development work, while AmplifyBio will be able to leverage established platforms and processes to offer optimization, characterization, safety, and efficacy services to preclinical clients, particularly those seeking to better understand the immunology of their advanced therapies.

Discovery

  • Target Validation
  • Identification of TCRs
  • Generation and optimization of cell therapy plasmid vector payloads
  • Prediction of neoepitopes that bind HLAs


Analytical

  • Protein identity confirmation by LC-MS
  • Determination of cytokine concentration in T-Cell culture
  • HPLC-based quality control assay for streptavidin reagent used in the release
  • In silico TCR clustering
Characterization
  • Functional characterization of cell products
  • Generation of functional cell lines
  • Cell phenotyping by flow cytometry
  • Tumor killing assays
  • Cell proliferation assays
  • MOA studies/assays
  • Alloreactivity assays
  • Tumor microenvironment characterization by transcriptomics
  • Genotype/phenotype analysis of cell product pre and post-dosing
  • Assessment of TCR specificity using protein libraries or pulsed cells
Process Development 
  • Reagent dose optimization
  • Research scale to at-scale product manufacturing
  • Optimization of media formulations and process parameters
cGMP Support
  • Troubleshooting manufacturing lot failure 
  • Engineering selection marker into cell product vector
  • Optimization of markers to determine incoming cell quality

Bioinformatics and Software

  • Machine learning and prediction
  • Genomics and transcriptomics
  • Analysis and pipeline automation
  • Cloud and systems architecture
  • Database portal design and integration

Contact Us

With the expertise to design the right study for every model and flexibility for data-driven implementation, AmplifyBio is your partner to trust for Preclinical Contract Research Organization Services. Talk with us and discover how we can support your study and compliance requirements.