The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.
- Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes?
- Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry
- Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical Trials
- Program Manager Alignment And Integration: Best Practices When Working With A CDMO
- New Guide Aims To Build Robust Framework For Digital Validation Tools
- Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms
- The 9 Fastest-Growing Outsourcing Segments
- Takeda Reimagines Biopharma Quality For The Digital Age
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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A Hybrid Modeling Approach To Accelerate Media And Feed DevelopmentExplore the outcomes of a study focusing on building a mechanistic model to determine the growth kinetics of a CHO-based process producing a mAb.
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Rapid And Robust Preclinical And Clinical Development Of CAR T-Cell TherapiesStreamline CAR T-cell therapy development with integrated support for asset identification, IND submission, early-phase studies, and advanced real-time tracking solutions.
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![GettyImages-533059254-rna-dna-strand-light]( "Optimizing siRNA Therapeutics: Addressing Manufacturing Complexities")
Optimizing siRNA Therapeutics: Addressing Manufacturing ComplexitiesDiscover key strategies to optimize siRNA therapeutics by addressing critical nonclinical and manufacturing challenges for a smoother path to commercialization.
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Residual Plasmid Quantification In Gene Therapy Manufacturing WorkflowsThis article details the design and application of a Plasmid DNA - Kanamycin Resistance Gene (pDNA-KanR) kit for residual plasmid quantification in gene therapy manufacturing.
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A Study To Assess Organoid Size And Cell Count From 3D Image AnalysisRecent advancements in 3D patient-derived organoids (PDOs) offer improved predictive power over traditional 2D assays. Explore a patented bioprocess for PDO expansion that could revolutionize drug discovery, especially in oncology.
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Inside A Collaboration To Design Cutting Edge Modular CleanroomsLearn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.
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![Roche - EndoCleave]( "Understanding EndoCleave's Role In Viral Vector Manufacturing")
Understanding EndoCleave's Role In Viral Vector ManufacturingAchieving high-quality viral vectors demands rigorous control over contaminants. Learn about enzymatic approaches to significantly reduce nucleic acid impurities in your manufacturing processes.
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Industry-Leading Advanced Therapy Support Revolutionizing TransportLearn about a validated dry ice shipping system that fills a critical gap in the life sciences industry and is revolutionizing the transport of high-value commodities such as advanced therapies.
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The Value Of Peptones For Cost-Effective Vaccine ManufacturingPeptones offer a strategic solution to key biomanufacturing challenges by enhancing cell culture performance, improving yields, and reducing production costs.
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5 Must-Haves For Electronic Batch Records In Life SciencesCompanies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.
NEWSLETTER ARCHIVE
- 11.04.25 -- Advancing Gene Therapy For FTD
- 11.03.25 -- Best Practices When Working With A CDMO
- 11.03.25 -- Simplify The Journey Of Advancing Your Therapies To Patients
- 10.31.25 -- Bringing CGT Home: Equipping Community Hospitals For The Next Frontier
- 10.30.25 -- Selecting Single-Use Cryopreservation Solutions
- How Early Manufacturing Decisions Shape Long-Term Success
- Understanding CLL And SLL Treatment Evolution
- Advancing Telomere Targeting Therapy For Non-Small Cell Lung Cancer
- BlueRock Advances Cell Therapy For Parkinson's Disease
- Driving Prostate Cancer Innovation Through Immunotherapy With OS Therapies' Dr. Robert Petit
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.
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