Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.
- PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand
- ICH Revises Q1 Guideline, Advancing Stability Testing Standards
- Navigating CGT Biotech's Financial Headwinds And The Path Forward
- What CDMOs Wish Biotechs Knew Before Submitting An RFP
- 8 Actions To Redefine Sponsor–CDMO Relationships
- Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
- Why You Need A Raw Material Control Strategy
- Why Pharma Risk Assessments Should Include 'Working Together Alone'
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Global Outlook Of Multi-Specific Monoclonal Antibodies: Asia Pacific Focus
Learn about the global clinical trial landscape of multi-specific monoclonal antibodies (Mabs), with emphasis on trends in the Asia Pacific, and recent advancements in the field.
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Navigating The Biotech Landscape Amidst Covid-19 And Beyond
Access comprehensive insights and analysis for a deeper understanding of the biotech landscape, including optimism and challenges felt throughout 2023 and what the future could hold.
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Alternatives To CRISPR-Cas9: Nucleases For Next-Gen Therapy
Alternatives to CRISPR-Cas9 address limitations like delivery challenges and off-target effects. Emerging nucleases offer improved specificity, smaller sizes, and therapeutic applications.
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High-Yield Expression Of Complex Proteins From Stable Pools
This study presents the development of apoptosis-resistant CHO cell lines (DKO1 and DKO2), using electroporation technology, with the goal of enhancing biotherapeutic production.
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The Complete Flow Cytometry Guide
This guide covers the fundamentals of flow cytometry, aiming to help you better understand how it works, when it is most valuable, and how to conduct an experiment.
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Characterize Deglycosylated NISTmAb Using icIEF-UV/MS
Examine a comprehensive analysis of deglycosylated NISTmAb (dgNISTmAb) using a novel integrated icIEF-UV/MS workflow.
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Vertical Wheel Application Guide For MSCs And PSCs
Unlock the full potential of your hiPSC research. Explore how Vertical-Wheel technology enhances culture homogeneity and expansion, paving the way for breakthroughs in cell and gene therapy.
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Maintain Sterility And Ease In CGT Development, Including Cryopreservation
Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Finding An Optimal Harvest Solution By Considering Both Cost And Sustainability
Optimize your bioprocessing harvest with single-use centrifugation. Reduce costs, waste, and space needs compared to traditional depth filtration methods.
NEWSLETTER ARCHIVE
- 04.30.25 -- Residue Management In Cleanrooms
- 04.30.25 -- Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs
- 04.29.25 -- STREAM Edition: How The FDA Strengthens Industry Collaboration
- 04.29.25 -- The Cell And Gene Therapy Dilemma: Centralized Vs. Decentralized Manufacturing
- 04.28.25 -- Vial Containment Systems For Gene Therapies

- Navigating CGT Biotech's Financial Headwinds And The Path Forward
- How Cynata Therapeutics is Unlocking the Power of iPSCs to Transform Regenerative Medicine
- Emerging Technologies For Cell Therapy Manufacturing
- Collaboration Leads To CGT Progress At Astellas' West Coast Innovation Center
- Tessera Therapeutics Advances In Vivo Gene Therapy For SCD
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