Newsletter | September 3, 2024

09.03.24 -- Developing And Manufacturing Oligonucleotides: An Overview

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AAV Capture And Empty-Full Separation Strategies

There are challenges in AAV empty-full separation in the gene therapy industry as well as some misconceptions. Experts are always looking for ways to find the best solution to these challenges. Through this article, you will discover the strategies of AAV capture and empty-full separation, as well as the trends driving innovation in this area. Read it here.

FOCUS ON MANUFACTURING

Developing And Manufacturing Oligonucleotides: An Overview

An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.

How Digitalization Helps Manufacturers Overcome Operational Challenges

Explore how digitalization can significantly enhance control and accelerate processes for cell and gene therapy manufacturers, driving greater efficiency and innovation.

Fluid Connection Technologies For Sterile Fill/Finish Process Design

Single-use technology and innovative fluid connections play a significant role in creating an effective, sterile fill and finish operation that maintains the integrity of your biologic products.

Design Verification Testing Of Combination Products

Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.

Enabling Rapid Cell Line Screening To Reach Results Faster

The development of mAb based therapeutics can be a time-consuming and costly process of cell line establishment, but high-throughput screening and automated methods for IgG quantification can help.

A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation

Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

4 Common Types Of Cryogenic Studies For Advanced Therapies

Learn why cryopreservation studies are so critical and how biopharmaceutical manufacturers can more easily navigate the complexities of this process.

Exosome Isolation By TFF And Size Exclusion Chromatography

Here, we demonstrate a scalable workflow for the isolation of exosomes that combines tangential flow filtration for the concentration of exosomes followed by gentle size exclusion chromatography.

Strategies For The Separation And Analysis Of Empty And Filled Capsids

Explore approaches for the capture and separation of capsids, upstream strategies for reducing the level of empty and partially filled capsids, trends in AAV capsid design impacting purification, and more.

Automated Evidence Of Clonality

Proof of monoclonality is regularly a bottleneck in the cell line development workflow. Uncover an innovative piece of cell line development imaging technology.

Advanced Therapy Manufacturers' Checklist For Cleanroom Project Success

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Building A Robust Cell And Gene Therapy Supply Chain

As cell therapies develop and become more commercialized, manufacturers must adopt a sophisticated supply chain that provides the necessary materials and technologies to support therapeutic development.

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The supply chain for mRNA-based cell and gene therapies presents unique challenges due to the sensitive nature of these products. Join Cell & Gene Live on September 24th for a digital discussion on how the industry can improve the efficiency, reliability, and scalability of the supply chain for mRNA-based therapies. Registration is free thanks to the support of Roche CustomBiotech.

MANUFACTURING SOLUTIONS

On-Line Glucose And Lactate Analyzer: MAVEN - 908 Devices

NB-ROC™ T Cell SF Media - Nucleus Biologics

Project Management Process During A Mobile cGMP Compliant Facility Build - Germfree

Cleaning And Disinfectant Bucket System For Manufacturing - Contec, Inc.

Modular Facilities - The Proven Response For Rapid Biomanufacturing Anywhere - Cytiva

Quantum Flex Cell Expansion System - Terumo BCT

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Webinar: Elevate AAV Manufacturing: Tailored Cell Lines For Purity And Sustainability

Skillfully crafted cell lines for recombinant AAV production can help to reduce manufacturing costs and environmental impact. Join us as we explore a portfolio of engineered cell lines and the impact of adopting them for AAV production, focusing on sustainability improvements and regulatory implications.  Learn how cell line engineering can tackle encapsidated host cell DNA (ehcDNA), a contaminant that current downstream processing can’t remove. 

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