Cell And Gene Articles, App Notes, Case Studies, & White Papers
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Custom Designed Clinical Manufacturing Cleanrooms For Penn Medicine’s Cell And Gene Therapy Operations
8/9/2019
A GMP manufacturing suite was developed which included a custom-designed and constructed Clinical Manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.
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Using Software Systems To Drive A Successful CPV Program
6/25/2020
This paper covers pharma manufacturing data management systems, with insights on how purpose-built systems incorporated into your CPV program meet FDA requirements and protect your business.
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Collaborative Relationship Allows Avectas To Accelerate The Translation Of SOLUPORE™ Into The Clinic
9/9/2020
Avectas, a cell engineering company, was preparing its non-viral cell engineering solution technology for commercialization and required its platform to be assessed by an experienced third party. They requested support from CCRM, a Canadian centre of excellence in cell and gene therapy and a reliable partner to extend their development capacity and capabilities.
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Analysis Of Mixed Microbial Populations And Deep Immunotyping Of Peripheral Blood On The ZE5™ Cell Analyzer
12/27/2018
With up to five lasers and 30 analysis parameters, the ZE5™ Cell Analyzer is well equipped for complex multiplex analysis of cells. It is able to successfully perform large panel immunophenotyping and can also distinguish a wide range of bead sizes and mixed microbial populations.
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Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances And Challenges
11/26/2019
Cell therapy has proven to be a burgeoning field of investigation, as evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. There is now a more concerted effort among manufacturers to utilize traditional bioprocess principles to close, automate, and control these processes to ensure critical quality attributes (CQA) of the cell product are consistently maintained and manufacturing processes are cost-effective and risk-mitigated. This focused review will look at current solutions across a typical autologous or patient-matched manufacturing workflow and highlight remaining challenges toward industrialization of these processes.
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Multiplexing: Managing Risk With Proven, Single-Use Solutions
10/19/2020
Typically, demand forecasts for drugs prior to launch reflect a huge range of expectations. This illustrates just how hard it is to forecast accurately. Instead of trying to make better predictions (which will never be wholly accurate nor truly able to remove risk), or erring on the side of overcapacity (which is a drag on ROC), developers and CDMOs should seek manufacturing flexibility.
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Modular Bioprocessing Alleviates Drug Manufacturing Woes
4/4/2019
Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.
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Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing By Design” Methodology
7/13/2020
Contract development and manufacturing organizations need to play a critical role in the scale-up and industrialization of cellular therapies by providing customized tools and processes. The Manufacturing by Design approach for addressing the industrialization of cell therapies allows for optimal production conditions.
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Meeting The Process Development Challenges Of A Diverse Biologic Pipeline
9/10/2020
The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.
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Extractables Testing On Single-Use Connectors
7/2/2019
Appropriating BPOG testing on single-use connectors to mitigate the risks of E&L, as demonstrated in this article, is crucial to delivering safe and effective drugs.