Newsletter | October 21, 2024

10.21.24 -- Comparing In-House Vs. Outsourced Manufacturing Strategies For CGTs

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On-Demand Webinar - The Road to Approval: Viral Clearance Strategies for Non-Enveloped Viral Vectors

Did you know that the ICH Q5A(R2) guideline is now including the expectation for viral clearance studies for non-enveloped viral vectors? Watch this webinar to get the keys to design a successful study for your AAV products.

FOCUS ON OUTSOURCING

Comparing In-House Vs. Outsourced Manufacturing Strategies For CGTs

Each approach has its advantages and drawbacks, making the decision-making process crucial for your organization. This comprehensive guide is designed to help you determine which option, or possibly a hybrid strategy, is the most suitable for your company’s unique needs and goals.

Ensure A Seamless Handover Stage In The Technology Transfer Process

Understanding the key elements in the handover stage of a technology transfer is critical to your success. This is an overview of the Handover Stage of PDA TR-65.

The Potential Of Intensified Scalable Adherent Cell Culture — Part 2

Intensified adherent cell culture offers a promising solution to the limitations of traditional suspension culture, with the potential to improve efficiency, reduce costs, and accelerate development.

Realizing A New Approach To Allogeneic Cell Therapy Process Development

Increased investment in allogeneic therapies and process-level advancements to achieve commercial scale are paving the way for streamlined, standardized cell therapy development and manufacturing.

Methods For mRNA Poly(A) Sizing

This study used Oxford Nanopore Technologies' Direct RNA Sequencing Kit and obtained successful sizing of poly(A) tail regions. The results are presented in a histogram and table format.

Integrated Solutions For Advanced Therapies

The right CDMO offering integrated services can ease increasingly common CGT manufacturing problems such as scale, raw material access, viral vector production, and quality requirements.

Next-Generation CRISPR Approaches

By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.

Cell And Virus Banking In OV Development And Manufacturing

Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.

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It's no secret that on-going research aims to improve the efficacy and specificity of non-viral approaches for genetic engineering. But the field is rapidly evolving with research aimed at improving transfection efficiency, targeting, and safety profiles of non-viral delivery systems. Join Cell & Gene Live to discuss the most notable approaches and recent breakthroughs as well as promising non-viral vectors used in clinical trials. Attendance is free thanks to the support of MaxCyte.

OUTSOURCING SOLUTIONS

An Audacious Gene Therapy Program Creates A New CDMO Leader - Andelyn Biosciences

Ramp Up Your AAV Production With The Xcite AAV Platform Technology - Lonza

Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles - Battelle

A CGT CDMO With Devotion - Theragent

Groundbreaking Cryogenic Freezer Technology - Cryoport Systems

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