Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.
- How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing
- Gene Therapy: How Should We Approach Benefit And Risk?
- Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances
- CGTs for HIV Suppression with Addimmune's Dr. Marcus Conant
- Gene Therapy: Global Market Trends & Notable Developments
- Addressing Challenges In Serialization For Complex Therapeutics
- Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
- New Initiative Seeks To Back Up ICH's Harmonization Mission
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges
Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.
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Cytokine-Mediated Inflammation In A Relevant Preclinical Model
Learn about a novel preclinical model and how it enables the study of cytokine-mediated barrier inflammation mechanisms as well as the efficacy of anti-inflammatory therapeutics.
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Real-Life Application Of Intensified Chromatography – See The Results
Explore the impact and benefits of multi-column chromatography, taking into consideration product quality consistency as well as the potential cost and resin savings compared to batch chromatography.
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A Simple Flow Cytometry-Based Assay For Detecting CAR Expression
Learn more about fluorescent-labeled recombinant proteins that allow chimeric antigen receptors (CARs) to be directly stained and detected by flow cytometry.
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Expansion Of MDCK Cells On Microcarriers Via Growth In Stirred Vessels
We demonstrate how microcarriers provide an ideal substrate for expansion of MDCK cells in closed stirred-vessel systems and lay the groundwork for subsequent developmental studies in larger bioreactor formats.
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From Bench To Billions: Facilitating Scale-Up Of Adherent Cultures For Cell And Gene Therapies
We review what researchers should consider when they are creating a risk-mitigating adherent culture process for cell and gene therapy scale-up.
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Determining RNA Integrity And Purity By Capillary Gel Electrophoresis
To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.
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Expertise In RNA Therapies: Client Success Stories
Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.
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Natural Killer Cells Manufacturing
Follow the feasibility of xeno‑free NK cell expansion, closure of key unit operations, and how future work could focus on fine‑tuning each step to generate a robust, scalable process.
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Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
NEWSLETTER ARCHIVE
- 05.20.24 -- Establishing The Framework For Successful Clinical Manufacturing
- 05.20.24 -- Addressing Challenges In Serialization For Complex Therapeutics
- 05.16.24 -- Looking For Help With Your Cell & Gene Therapy Manufacturing Project?
- 05.16.24 -- Selecting Single-Use Cryopreservation Solutions
- 05.16.24 -- CGTs For HIV Suppression With Addimmune's Dr. Marcus Conan
- Is A One-Time Cure for HIV on the Horizon?
- Cell & Gene: The Podcast Post-Episode Recap: BlueRock Therapeutics’ Dr. Ahmed Enayetallah
- Cell & Gene: The Podcast Post-Episode Recap: Vor Bio’s Dr. Robert Ang
- 2024: The Year of Development in Cell Therapy
- Nanoscope Therapeutics Tackling Vision Loss With Ocular Gene Therapy
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
More Content Collections