Newsletter | March 31, 2025

03.31.25 -- Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies

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Webinar: Harnessing AI, Spatial Transcriptomics & Mass Spectrometry for Clinical Insights

This webinar covers how preserving spatial molecular information enhances tissue analysis. It explores spatial-Omics platforms, AI models predicting treatment responses, and identifying patient subgroups. Topics include spatial-omics integration, AI-driven predictions, oncology applications, and improving molecular signatures for personalized medicine. Click here to learn more.

FOCUS ON OUTSOURCING

Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies

Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

The Next Frontier: Industrializing Cell Therapy Manufacturing

Learn how leveraging platform processes can enable flexible service at each level – pre-clinical through commercial – and reduce development timelines and costs on the path to market.

Transferring Potency Assays From Lab To GMP Production

With experience in managing assay transfers across diverse sources and development stages, we have identified five critical factors that can significantly impact the success of potency assay transfers.

Coordinating Global Capabilities To Support A Gene Therapy

Discover how our integrated expertise in GLP toxicology, biodistribution, and CMC services helped a biotech company secure IND approval for a groundbreaking gene therapy.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

ATLAS: A High-Throughput Screening Platform For Optimizing AAV Production

To overcome manufacturing bottlenecks and reduce the high cost of gene therapies, our ATLAS platform has identified novel factors that boost rAAV9 production over 30-fold.

When Two Outta Three Is Bad…For Patients, Regulators And Biopharma

Help transform the development of advanced therapies by embracing a new standard that delivers quality, speed, and cost-efficiency without compromise.

Key Analytical Considerations For Developing A Clinical AAV Program

Unlike traditional drugs, AAV therapies require extensive characterization and testing, demanding varying degrees of analysis at each stage of development.

Tackling Antimicrobial Resistance

Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.

Streamline The Path From Discovery To Patient: Simpler RNA Manufacturing

Review the benefits of a co-transcriptional capping RNA polymerase engineered to produce synthetic RNA to meet these increasing demands for safety and cost-effectiveness.

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4th In Vivo Cell Engineering & Gene Editing Summit

June 3-5, 2025 | Boston, MA 
Join the 4th In Vivo Cell Engineering & Gene Editing Summit, the premier event advancing in vivo cell and gene therapies from research to clinic. Gain exclusive insights into IND-enabling data, regulatory pathways, next-gen delivery, and breakthrough innovations. Hear from leaders like Capstan, Editas, AbbVie & more to stay ahead in oncology, genetic, and rare disease therapies. Learn more.

OUTSOURCING SOLUTIONS

Explore SGS's Comprehensive Biologics Testing Capabilities - SGS

IDT Biologika Capacity Update October 2024: Cell & Gene Therapy - IDT Biologika

UpTempo AAV Platform Process - Catalent

ElevateBio Capacity Update October 2024: Cell & Gene Therapy - ElevateBio

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