Newsletter | January 13, 2022

01.13.22 -- Inside The Human Virome & Next-Gen Gene Therapy Vectors

Featured Editorial
Industry Insights
Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?

The most common storage is ultra-low temperature storage, but the fastest growing is cryogenic, in vapor phase liquid nitrogen. This transition is huge. Chain of temperature and custody data is imperative.  

Considerations For Creating Plain Language Summaries

Given that writing plain language summaries can be a lengthy undertaking — especially if translations or a patient review panel are called for — sponsors would be well advised to start the process now. Explore the keys steps to starting this process.

The Raw Material Hurdle: Plasmids For Viral Vector-Based Gene Therapies

The success of using viral vectors to deliver a molecular payload into a cell or replace defective genes with functional ones is an inflection point in the future of modern medicine.

Overcoming Obstacles In Adeno-Associated Virus (AAV) Viral Vector Manufacturing

Rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral-vector manufacturing platforms. The upstream and downstream processes of AAV manufacturing can be fairly straightforward at small scales. However, obstacles often are encountered when a developer progresses toward larger volumes for clinical and commercial manufacturing. In this article we discuss overcoming obstacles that often come up during transfection, clarification, and the separation of empty and full capsids.

Rewriting The Health Code: How mRNA Technology Is Shaping The Future Of Medicine

Discover how mRNA technologies open the doors to a whole range of new gene therapies and the role of lipid nanoparticles (LNPs) in current and future developments.

New, LN2-Free Solution For Cryogenic Transport Of ATMPs

Administration of cell therapies, in clinical trials or as commercial products, involves complex logistics between sometimes numerous partners and sites, making timing critical. A better understanding of the boundaries not to be crossed, in terms of transit time and temperature, to maintain cell integrity post-thaw, is studied here.

Apply For A Breakthrough Therapy Designation (And Win It!)

GlaxoSmithKline's Dr. Ira Gupta and Gilead Sciences' Dr. Shanthi Ganeshan break down breakthrough designations, winning them, and bouncing back from rejection.

10 Reasons Formulation Complexity Is On The Rise In Steriles

Complexity is rising in sterile injectables, driven by factors that include formulation and delivery. Reduce complexity and save time on the way to IND authorization and first-in-human trials.

Quality By Design: The Highest-Standard Approach To Process Validation For Early And Late-Stage Projects

The challenge was to identify an effective, replicable, and large-scale lentiviral vector (LVV) manufacturing process to meet the growing manufacturing demand — especially for market application — without affecting critical quality attributes.

Key Considerations For Laboratory Facility Design Planning And Optimization

Laboratories are an integral part of the pharmaceutical industry. They are used at each stage of the product development. See how this solution allows you to plan projects without having to build new labs and gain the ability to plan projects better, manage inventory, be nimble in responding to demand fluctuations, avoid under and/or over utilization of talent, and gain reliable capital project planning that is based on actual utilization tracking.

One-Step Isolation And Activation Of Naive And Early Memory T Cells With CTS Dynabeads CD3/CD28

In this application note we demonstrate nearly 100% recovery of naive and early memory T cells using Gibco CTS Dynabeads CD3/CD28 beads. This one-step process of simultaneous T cell isolation and activation yields pure and uniformly activated T cells.

Pandemic Playbook For Gene Therapy Manufacturing

A conversation that discusses the challenges to gene therapy development and manufacturing created by the pandemic and lessons learned from the rapid vaccine development efforts that can be applied to transform the gene therapy field going forward.

Optimizing Viral Vector Production, Efficiency With Osmolality
Data from a recently completed study shows that a significant increase in yield and quality of an adeno-associated virus (AAV) was realized from a timed osmolality shift.
Considerations To Improve Patient Outcomes In Early Drug Development

Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes.

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