Welcome to the Cell & Gene Therapy Analytics Hub

Welcome to the Analytics Hub!

Explore a curated collection of technical insights, strategic guidance, and practical advice on leveraging the latest analytical tools to enhance the identification and measurement of critical quality attributes.

Designed as the go-to resource for professionals working to identify, characterize, and quantify unwanted contaminants- helping you stay ahead with next-generation tools built to deliver the speed, sensitivity, and reliability the industry demands.

CELL & GENE THERAPY INSIGHTS

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Content

How do I ensure my early-stage analytical development is ‘phase-appropriate’? Top 5 tips

Fit-for-purpose analytical development for an emerging cell therapy landscape﻿

eBook: Increasing speed and efficiency in biotherapeutics analysis

Early-stage analytical development strategies for cell therapy

Balancing precision and efficiency in cell therapy assays: low volume sampling for mycoplasma detection

Preparing for success in gene therapy analytical development

Cell therapy analytics: INFOGRAPHIC

﻿﻿Preparing for success in gene therapy analytical development

﻿﻿Early-stage analytical development strategies for cell therapy

4 key lessons learnt from choosing in-house assay development

Leveraging dPCR for residual DNA and viral titer quantitation in advanced therapy manufacture

﻿Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

5 dos and don'ts for regulatory compliance in AAV manufacturing

﻿Overcoming challenges in cell therapy production: rapid sterility testing

What goes into developing an in-house method for quantitation of residual host cell DNA?

Regulatory considerations and validation strategies for mycoplasma testing for cell-based therapies

Addressing regulatory guidance for HEK293 cells and AAV-based therapeutics manufacturing

Simplifying residual DNA quantitation and biotherapeutic manufacturing

Streamlining nucleic acid extraction for biotherapy manufacturing: manual and automated solutions for success

Considerations for affinity capture in an AAV platform downstream process

Simplifying residual DNA quantitation in biotherapeutic manufacturing

Analyzing lentivirus particles using dPCR techniques

Considerations for affinity capture in an AAV platform downstream process

Improving biopharmaceutical quality and safety by implementing a microbial identification strategy in the workflow

Regulatory considerations & validation strategies for mycoplasma testing for cell-based therapies

Navigating evolving regulatory CMC guidance in the AAV gene therapy field

Addressing regulatory guidance for HEK293 cells & AAV-based therapeutics manufacturing

Residual DNA testing: Homebrew vs off-the-shelf solutions: INFOGRAPHIC

Regulatory considerations and validation strategies for mycoplasma testing for cell-based therapies

Addressing regulatory guidance for HEK293 cells and AAV-based therapeutic manufacturing

Environmental monitoring: optimizing microbial control in cell & gene therapy workflows

Optimizing the cell therapy patient journey through integrated CRO/CDMO partnership

Navigating evolving regulatory CMC guidance in the AAV gene therapy field

Simple analytical tools for detection of impurities in biologics produced using the Sf-baculovirus platform

Environmental monitoring: optimizing microbial control in cell and gene therapy workflows

Navigating evolving regulatory CMC guidance in the AAV gene therapy field

Analytical innovation: meeting the demands of commercial viral vector manufacture

Lentiviral titer determination: rapid & robust molecular methods suitable for validation

Lentiviral titer determination: rapid & robust molecular methods suitable for validation

Mycoplasma testing: regulatory guidance and strategies for cGMP cell and gene therapy manufacturing

Robust quantitation of residual host cell and plasmid DNA & oncogenic fragments in HEK-based viral vector manufacturing

Simplifying analytical development of viral vector production: robust and sensitive methods for common expression systems

Removing technological barriers to efficient large-scale LV vector production

Removing technological barriers to efficient large-scale LV vector production

Simplifying analytical development for viral vector production: robust and sensitive methods for common expression systems

Key factors to consider for successful cell therapy manufacturing: a case study

Residual DNA testing in viral vector manufacture: exploring the challenges and solutions

Expression systems for viral vector production: advantages of the Sf9 baculovirus system and simple solutions to address its specific analytical challenges

Manufacturing and analytics for lentivirus and AAV vectors: a visual and audio guide

Development & validation of a robust commercial solution for measuring residual kanamycin-resistant plasmid DNA

Expression systems for viral vector production: advantages of the Sf9 Baculovirus system and simple solutions to address its specific analytical challenges

Mycoplasma detection in cell therapy products: GMP-compliant implementation & validation of a commercial real-time PCR assay for routine quality control & lot release

Viral vector production process intensification: analytics, automation, in-line testing and more

Viral vector production process intensification: analytics, automation, in-line testing, and more

Scalable AAV manufacturing – Addressing challenges across the workflow

Combining state-of-the-art production, purification and analytics to optimize AAV manufacturing for clinical and commercial gene therapies

AAV vector process development: achieving high purity and high yield – experiences from the frontline

AAV vector process development: achieving high purity & high yield – experiences from the frontline

Any Questions?

Fit-for-purpose analytical development for an emerging cell therapy landscape

Preparing for success in gene therapy analytical development

Early-stage analytical development strategies for cell therapy

Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

Overcoming challenges in cell therapy production: rapid sterility testing