The Jefferson Advantage

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We are IP-friendly, guided by a focus on early process development to ensure maximum dividends, and driven to deliver projects on time, on target and on budget.

Highly customer-focused, we offer through our matrix model a wide array of services, including: Process Development, Product and Technology Development & Evaluation, Process Analytical Technology and Workforce Development.

Our Services:

Our clients are engaged in cell and gene therapeutics across multiple disease areas, including oncology, neurodegenerative diseases and more.

Fully flexible, single-use facility with BSL1 and BSL2 bioprocessing capabilities for:

  • Cell and gene therapies
  • Viral vectors
  • Monoclonal antibodies
  • Advanced vaccines

Examples of Client Projects at JIB:

  • AAV and Lentiviral Manufacturing
  • Human induced pluripotent stem cells (iPSC)
  • Car-T cell therapy
  • siRNA therapeutics
  • Monoclonal Antibody therapeutics

Dedicated bioanalytical capabilities for:

  • Physical and biophysical characterization
  • Formulation development and optimization
  • QC testing and release studies
  • Stability testing
  • Potency and efficacy
  • Process development support

We offer a world-class, pilot-scale, simulated GMP facility and support to evaluate clients’ technology, equipment and processes in an IP-friendly environment. 

Examples of client projects focused on technology evaluation improvement include:

  • Novel technology for the separation of empty / full capsid
  • New platform for human cell culture proliferation and differentiation
  • Next generation process monitoring and measurement
  • Evaluation of new container closure for cell therapy
  • Media evaluation optimization for cell therapy
  • Formulation for cell therapy and stem cell therapeutics
  • Scale-down modeling of centrifugation for shear sensitive mammalian cells
  • Evaluation of next generation continuous bioprocessing unit operations
  • Developing next generation platform for AAV and LV manufacturing

We provide Phase Appropriate Analytical Testing for biopharmaceutical products.

Our key areas include, but are not limited to:

  • Titer, size exclusion, acid base variants, empty vs full capsid analysis using HPLC based methods
  • Characterization of biopharmaceuticals using LCMS
  • Detailed analysis, including glycan analysis, using capillary isoelectric focusing
  • Cell imaging techniques using nucleocounter (NC-202), fluorescent and confocal microscopes
  • Flow cytometry based cell differentiation assays
  • Purity using gel electrophoresis (SDS PAGE)
  • Gene expression, genotyping, copy number variation (CNV) and miRNA profiling using PCR
  • Analyze size distributions of proteins, nanoparticles, viruses, micelles using multi-angle DLS
  • Flexible range of measurement technologies including absorbance, fluorescence intensity, luminescence, alphaScreen, and time-resolved fluorescence
  • High-throughput ELISA assays using Gyrlolab xPlore
  • A multitude of analytical and cell imaging techniques available at Thomas Jefferson University analytical core

Good training programs support value drivers in a company and increase profits by minimizing cost of poor quality (CoPQ).

Examples of customized client training courses and programs include:

  • Hands-on new employee onboarding program for a mid-sized company
  • Bioprocessing for sales and marketing teams of a Fortune 500 company
  • Multi-level programs delivered across 12 months to a Fortune 500 biomanufacturer
  • Asceptic process qualification and training
  • Application of single-use technologies in biopharma for a technology provider
  • Introduction to Upstream and Downstream operations in biopharma for multiple manufacturers, technology providers and equipment vendors
  • Leadership training seminars for multiple industry clients
  • Biopharma 4.0 technology implementation and industry engagement
  • Advanced chromatography design and operation delivered over a dozen times
  • Advanced mammalian cell culture design, scale-up and operation delivered multiple times to multiple companies throughout the year
  • Computational modeling and process integration
  • Automation and control and process analytical techniques
  • Continuous bioprocessing and process intensification
  • CMC, QbD, AQbD & GMP, Quality Management
  • Regulatory aspects of Biologics and Biosimilars
  • Analytical Method Validation
  • Formulation
  • Manufacturing challenges and opportunities in cell and gene therapies
  • Developing platform operations for the manufacture of AAV & LV vectors for cell and gene therapy applications
  • Manufacturing of advanced vaccines including recombinant subunits, VLP, and mRNA
  • Business of Biomanufacturing