Newsletter | March 21, 2024

03.21.24 -- The Impact Of Automation And AI On Gene Therapy

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Stem cells are the backbone of many allogeneic therapies and where they come from affects development and supply chain logistics, particularly cryopreservation. What temperatures are ideal to maintain product potency? How do you build a reliable cold chain? How do you work with existing infrastructure to allow for an “off-the-shelf” therapy? Don’t miss the next Cell & Gene Live digital event! Registration is free thanks to the support of Charter Medical and Bio-Techne.

FEATURED EDITORIAL

Exploring The Impact Of Automation And AI On Gene Therapy

A panel of experts discusses best practices for aligning automation technologies with short-term and long-term gene therapy goals.

Dr. Peter Marks On The Adoption Of Novel Precision Analytics

Hear advice for developers who are worried that the FDA will not accept changes in their process that include a new analytical method.

INDUSTRY INSIGHTS

Resolving Common Single-Use Concerns

Demand for single-use production tools, components, expertise, and capabilities grows as cell therapies evolve. However, concerns and misconceptions remain about single-use solutions.

Implementing A Risk-Based Approach To Calibration

Using information from user requirement specifications and other documents, this article suggests companies may benefit from a risk-based approach to calibration.

Insights Into Candidiasis: Global Clinical Research Overview

Explore how drug-resistant strains are posing challenges when it comes to the treatment of candidiasis, but therapeutic advancements and ongoing research are offering hope for improved outcomes.

Outsourcing Vendor Red Flag #2: Oversight And Process

Depth of management typically is less about ensuring your trial progresses smoothly and more about hiding the CRO’s deficiencies or appeasing its own stakeholders.

Characterizing AAV Encapsidated Nucleic Acid Sequences Using NGS

Here, we discuss the characterization of several representative AAV molecules using next-generation sequencing (NGS), including the sequencing process, bioinformatic analysis, and representative results.

What To Know About CRISPR Screens And Bulk Spheroid Production

Achieve a more physiologically relevant setting with less reliance on model animals when studying diseases like cancer through the combination of CRISPR screening and bulk spheroid production.

Streamlining Change Control To Increase Efficiency And Compliance

Uncover a holistic approach to streamline the change control process, which aims to increase efficiency and compliance, improve quality, and shorten time-to-market.

Assurance Of Clonality For Biotherapeutics

The clonality of master cell banks (MCBs) for production cell lines is a key requirement in biotherapeutics manufacturing. Learn how new devices help optimize the cloning process.

Pursuing Breakthrough Therapies For Rare Metabolic Diseases

Discover how Veristat’s full-service clinical trial team helped tightly coordinate a gene therapy's dosing administration and data review.

Strategies To Overcome Delays In The Development Of Genomic Medicines

Genomic medicine provides an excellent prospect for faster drug development. See how optimizing LNPs can help overcome drug-delivery challenges, unlocking potential new genomic medicines faster.

Leveraging Tech, Regulatory Frameworks To Deliver Patient Access Today

Amidst the shift toward decentralized manufacturing models, consider an approach that allows for standardized processes, remote monitoring and control, and centralized quality oversight.

SOLUTIONS

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