Newsletter | October 12, 2021

10.12.21 -- Spark Therapeutics' Dr. Chang on Next Steps in Hemophilia A

 
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Key Considerations: How CDMOs Can Maximize Productivity And Scalability

Urgent demand for new vaccines and treatments has increased the biopharmaceutical industry’s need for resources in a way that requires transformational operational changes. To meet this demand and accelerate the delivery of life-saving medicines, the industry must maximize development and manufacturing efficiencies, as well as increase production capacity, while maintaining high quality and minimizing risk.

Advanced Therapy Drug Manufacturers' Checklist For Cleanroom Project Success

We are in the midst of a next-generation scientific revolution in personalized therapeutic medicines; however, the design of manufacturing infrastructure continues to follow an outdated playbook. 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. This article shares what factors are central to successful entry into commercialization of new therapeutic production capital projects.

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.

5,000 L Single-Use Bioreactors: The Next Generation In Biologics Manufacturing

A new generation of single-use bioreactors, built to deliver high-volume performance, addresses many issues: a demand for therapeutics, expanding indications for biologics, and the growing portfolios of biosimilars.

Build A Better Oncology Patient Experience: Supporting Participants Throughout A Study

Patient recruitment gets all the attention at an oncology study’s inception, but enhancing patient engagement throughout the study bolsters retention, long-term follow-up participation, and the likelihood of patients volunteering in future trials.

Quality Matters: SEC Analysis For Antibody Aggregates

Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

Got Approval … Now What? Meeting Cell Therapy Market Demand

The commercial success of a cell-based therapeutic depends on a scalable, automated manufacturing process. But how can companies ensure their manufacturing processes are up to meeting the needs and market demand of the rapidly evolving cell therapy field? This blog highlights the insights from industry experts on the subject at a recent breakfast briefing at Phacilitate 2020.

Choosing Optimal Harvesting Solutions

There are many reagents available for harvesting anchorage-dependent cells. Options include solutions that are animal-derived, recombinant, or fully synthetic. Although some harvesting reagents are more common than others, each can impact cell recovery, viability, and functionality. In this article, we highlight commonly used harvesting reagents and their advantages.

Enhancement Of Transient Transfection With Serum-Free And Blood-Free Transferrin

Methods to enhance transient transfection of adherent cells have identified many different ligands that improve plasmid uptake into cells. Of these ligands, serum-derived transferrin is well-known to improve transfection efficiency of adherent cells. However, to date, a serum-free and blood-free transferrin has not been tested for improvements to transfection efficiency. We have thus created a protocol for the improvement of transfection efficiency and viral titer without the need for blood-derived transferrin.

2020 Completed Trials: A Bumpy Road For Industry-Sponsored Clinical Studies

The COVID-19 pandemic created delays for trials that were planned for completion in 2020 and directly contributed toward trial terminations. Despite this, more diseases, and more indications outside of oncology, achieved at least 25 successful trials. Read the full report.

Single-Cell Passaging With NutriStem hPSC XF On Laminin-521 Without The Need For ROCK Inhibitor

Human pluripotent stem cells (hPSCs) have great potential for cell therapy and regenerative medicine in many severe diseases. Removing xeno components and using feeder-free cultures is necessary to ensure robust and reproducible colonies during culture. This paper explains how the combination of xeno-free media (i.e., NutriStem hPSC XF), recombinant protein matrices (i.e., LaminStem 521), and recombinant trypsin solutions (i.e., Recombinant Trypsin EDTA Solution) enables single-cell passaging without the addition of ROCK inhibitor, while maintaining cell integrity and characteristics.

Shorten The Seed Train With High-Density Cell Banking

The current process of growing production-level biological cultures from a single cell sample has two major difficulties: It takes a long time and includes many opportunities for contamination. Entegris can help with Aramus single-use fluoropolymer bags. Here’s how.

Achieving A Flexible, Integrated, And Sustainable Cryogenic Cold Chain Ecosystem

During this discussion, panelists examine the cell and gene therapy solutions that have been designed to overcome challenges in the cryogenic cold chain ecosystem.

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