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Technical/Service brief
GMP Tissue Sourcing
A complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity, and pass BLA approval. Download our infographic to learn more
White paper
The Early Advantage for IND Success and Beyond
Many of the decisions made during the early days of building and compiling the manufacturing information for your IND submission will directly impact the future cGMP manufacturing operations and simply become foundational for the commercial viability of t...
Webinar (on-demand)
Establishing the Standards of Operational Excellence to Manufacture Commercial Cell Therapies
After entering Phase 3, cell and gene therapies experience nearly five times more discontinuations or significant delays due to CMC issues than monoclonal antibodies. The highly manual processes, lack of robust analytical methods, and lack of quality stan...
Video
bluebird bio and Lonza Reflect on Their 10-Year Journey Commercializing Two Gene Therapies
From clinical stages to FDA-approved gene therapies: At the 2023 CAR-TCR Summit in Boston, bluebird bio and Lonza took the opening plenary stage to share the unique story of our 10-year journey commercializing two gene therapies. Ten years ago, in January...
Webinar (on-demand)
Scale-up Allogeneic Cell Therapies to Large Patient Populations
A key benefit of allogeneic cell therapy is that it provides a substantial and economical cost structure, increasing the ability to treat larger patient populations. As allogeneic cell therapy continues its exponential growth, a scale-appropriate model in...
Presentation (on-demand)
Process development for CGT: How soon is too soon? (Geleen)
During the inaugural event of expanded Process and Analytical Development Laboratories at Lonza Netherlands, leaders and innovators from the industry look the stage for a panel discussion around process development and commercial readiness for cell & ...
Presentation (on-demand)
Process Development for CGT: How soon is too soon? (Houston)
During the inaugural event of expanded Process and Analytical Development Laboratories at Lonza Houston, leaders and innovators from the industry look the stage for a panel discussion around process development and commercial readiness for cell & gene...
Webinar (on-demand)
Process development best practices for CGT commercialization readiness
Our expert introduces some of the bioprocessing best practices required to de-risk the commercial manufacturing of cell and gene therapies. Watch our webinar to learn: the principles of commercialization readiness, logical steps and the best practice...
Peer-reviewed publication
Cell Counting Method Considering Cell Type, Precision, and Accuracy Requirements for Robust Process Development
Identifying a precise and accurate cell counting method considering the cell type and application is crucial for the development of robust and reliable manufacturing processes, product characterization, and eventually commercialization of the cell therapi...
Webinar (on-demand)
Overcoming quality and regulatory challenges for CGT commercialization
Our experts spoke about the strategies to meet the quality & regulatory requirements of cell & gene therapies (CGT), and Lonza's New Product Introduction process (NPI) for CGT manufacturing – how to identify issues early on, reduce qual...
e-book
The Cell and Gene Therapies Journey from Translation to GMP Production and Commercialization
Each journey in cell and gene therapy is unique, because each process is customized. It requires extensive experience in your specific modality of cell and gene therapy to anticipate the challenges you will face and to put in place a plan of action to add...
Presentation (on-demand)
Pre-developed Assays for Cell and Gene Therapies
In a presentation taking place in the opening plenary session of the Gene Therapy Analytical Development EU summit 2021, Dr Behnam Ahmadian, Global Head of Process Development for the Cell & Gene Technologies Business Unit at Lonza, introduces a library o...
Webinar (on-demand)
Key Regulatory Considerations for Cell and Gene Therapy Products 2021
Webinar presentation from Karen Wolfrom, Global Head of Regulatory, Cell & Gene Technologies on the latest and most important regulatory considerations in the pathway to commercialization of cell & gene therapy products
Webinar (on-demand)
Allogeneic CAR-T Manufacturing
Webinar titled 'Focus on allogeneic CAR-Ts manufacturing challenges and solutions' hosted by Bioinsights and featuring three lonza speakers from commercial development, Research & Development and Process Development.
Webinar (on-demand)
Meeting Regulatory Requirements for Cell and Gene Therapy Manufacturing
Existing regulatory landscape, guidance and regulations applicable to cell and gene therapy products, hot topics related to manufacturing facilities to be considered during regulatory filings, Segregation measures and controls.
Article
Manufacturing New Modalities
Biocentury article on regulation for manufacturing new modalities.
Video
ARM Manufacturing Panel
Alberto chairing manufacturing panel at March 2019 ARM investor day in NYC featuring Andy Holt, bbb, Voyager, Pfizer and GSK.
Video
Opening plenary address at the Phacilitate Leaders Summit from Alberto Santagostino
Alberto Santagostino, Head of the Cell & Gene Technologies Business Unit at Lonza, gave the opening presentation titled 'Keeping up with the pace of technology in an evolving field of innovation' at the 2019 annual Phacilitate Leaders' Summit in Miami...
Peer-reviewed publication
Report of the International Conference on Manufacturing
Elsevier peer-reviewed paper and international conference report on manufacturing and testing of pluripotent stem cells.
Video
Making it happen: the road to commercial-scale
1h webinar focused on CT technology platforms including autologous, 3D bioreactors, iPSCs.
Poster
Bioprocessing of cGMP Human Induced Pluripotent Stem Cells
Poster presented at ISCT 2018 on cGMP bioprocessing of hiPSCs in suspension bioreactors
Video
What is cell and gene therapy?
Educational video on what is cell and gene therapy and Lonza's role and positioning in this space. Created April 2018.
Video
Centers of excellence and Houston opening
Key messages around the CGT network and centers of excellence followed by the Houston grand opening video highlights.
Peer-reviewed publication
Human-Induced Pluripotent Stem Cells Manufactured
Frontiers in Medicine peer-reviewed paper on hIPSCs cGMP manufacturing.
Peer-reviewed publication
Bioreactors for Cell Therapies
ISCT peer-reviewed paper on Bioreactors for cell therapies.
Interview
Spotlight on Product Characterization
Bioinsights sponsored inteview on analytical tools, assay development and characterization.
Peer-reviewed publication
A Newly Defined and Xeno-Free Culture Medium Supports
PLOS one Peer reviewed paper on medium replacement in the generation of hiPSCs.
Peer-reviewed publication
Detailed Characterization of Human Induced Pluripotent
Springerlink.com peer reviewed paper on the characterization of iPSCs manufacturing.