Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
- MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
- Active Versus Passive Shipping Solutions For Clinical Shipments
- January 2026 — CDMO Opportunities And Threats Report
- Why In Vivo Therapies Fail When We Treat Them Like Ex Vivo Ones
- Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
- Why Clinical Supply Risk Starts With Demand Signals
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Bulk Filling Of Drug Substance | Accurate Aliquoting
Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.
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Streamline Analytical Tech Transfer Through Analytical Target Profile
Analytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.
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AAV Viral Titering Using Nanoplate-Based Digital PCR
Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.
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Five Essentials For Accurate Oligonucleotide Chemistry
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Optimizing DPI Production: Filling Technologies For Precision And Performance
Developing effective dry powder inhalers requires expertise across multiple disciplines, from particle engineering and device technology to manufacturing science and regulatory knowledge.
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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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Sterilizing Grade Filter Performance With Biologic Drugs
Examine the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins as well as how filter selection can impact your process.
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Guiding Principles For Process Development And IND Readiness
Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.
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Scaling Of Impingement Jets Mixing For LNP Drug Production
Delve into the intricacies of Impingement Jets Mixing (IJM) technology and its pivotal role in the scalable and reproducible production of Lipid Nanoparticles (LNPs) for drug delivery.
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Efficient Late-Stage Development Of Biologics
Reducing biologics manufacturing costs requires strategic late-stage process development, yield optimization, scale-up, and raw material substitution—all while maintaining product quality and regulatory compliance.
NEWSLETTER ARCHIVE
- 02.25.26 -- Securing And Strengthening Workflows From Design To Delivery
- 02.25.26 -- FDA's PreCheck Pilot Is Open: What You Need To Know To Apply
- 02.24.26 -- STREAM Edition: CGT Regulation In 2026 Moves Toward Disciplined Flexibility And Higher Standards
- 02.24.26 -- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
- 02.23.26 -- Mastering EU GMP Annex 1: Packaging, Performance, And Contamination Control
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026
- Global Shifts And Strategic Resilience Will Shape CGT In 2026
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
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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