Newsletter | June 13, 2024

06.13.24 -- Revolutionizing Modifier Gene Therapy Through A Gene-Agnostic Approach

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How to Boost AAV Titer with Feed Supplementation in both HEK293 and Sf-9 Platforms

How do you increase AAV titers in established AAV production processes? We evaluated select media and feed products as supplements during AAV production. Cellvento® ModiFeed Prime significantly increased AAV titers in HEK293 cell lines when supplemented post-transfection and in Sf-9 cell lines when supplemented post-infection. The volume and timing of the supplementation are critical. Learn more during this webinar. Register Here.

INDUSTRY INSIGHTS

Translating Study Reports – A GLP Draft Guidance

The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report includes a statement of certification requirements.

Matters Of Scale: Centralized Vs. Decentralized Manufacturing

In advanced therapy manufacturing, reducing human intervention and manual processes is critical to optimizing manufacturing paradigms, simplifying processes, and improving quality and efficacy.

Overview Of Endometrial Cancer: Global Clinical Trials Landscape

This FAQ delves into the latest developments in endometrial cancer treatment, highlighting innovative drugs, ongoing clinical trials, and their potential impact on patient outcomes.

Evaluating CAR T-Cell Therapy Recruitment And Efficacy

Learn about Organ-on-a-Chip technology and how it can be employed to assess the efficacy of CAR T-cell therapies against solid tumors.

Maintaining Aseptic Processes Using Small-Volume, Closed Systems

As autologous cell therapies and other targeted gene therapies work to scale up to commercial levels, connections that can be changed out in seconds represent a distinct advantage for the industry.

Streamlining And Enhancing Gene Therapy Production With Automation

When it comes to determining the appropriate analytics to inform early development, there are a number of variables to consider surrounding cost, operator expertise, and throughput.

The Critical Role Of Training In Cleanroom Cleaning And Disinfection

Understand why proper training is vital in cleanroom cleaning and disinfection and how to develop and maintain a successful training initiative.

Contamination Control Considerations For Cell And Gene Therapy Facilities

Gain a thorough understanding of active HEPA purging pass-throughs along with the numerous benefits associated with their use in cell and gene therapy facilities for material control.

Improving Flexibility And Participant Engagement For Oncology Patients

Flexibility is crucial when an oncology patient lives far away from a clinical research site. Gain insight from industry experts about participant engagement and the realities of supporting oncology patients.

Flexible Freeze Containers In Gene Therapy Manufacturing

With each batch of cell and gene therapy product representing a wealth of lifesaving potential, this biopharma company needed the right packaging solution for its relatively new therapy applications.

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.

InSiliCHO: Modeling Cell Line Dynamics For Process Development

Modeling and simulation can be a powerful tool for bioprocess design. Find out how you can utilize an open source implementation for in silico simulation of CHO.

Webcast: Development Of IEX Purification Process For Lentiviral Vectors

Explore data resulting from an initial high-throughput screening experiment carried out to broadly evaluate anion exchange resins that exhibited high LVV recovery.

FEATURED EDITORIAL

Revolutionizing Modifier Gene Therapy Through A Gene-Agnostic Approach

Traditional methods reliant on individual gene replacement strategies have limitations. Researchers are now investigating ways to use a single modifier gene to treat an array of diseases.

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With additional cell therapy approvals on the horizon, a diverse array of products and platforms are needed to ensure safety and efficacy in manufacturing, increase speed to market, and decrease overall COGS. Join Cell & Gene Live for a digital discussion on the next generation of platforms and innovative technologies. Registration is free thanks to the support of Invetech.

SOLUTIONS

Powdered Media For Cell Culture

Single-Use System For Clinical And Commercial Production Of LNPs

A Powerful Platform That’s Easy To Use

Freezing Studies For Single-Use Solutions

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