Services
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:
Process Development (End-to-End)
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
Product and Technology Development & Evaluation
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
Process Analytical Technology
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
Workforce Development
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