Newsletter | November 18, 2021

11.18.21 -- 3 Steps To Creating A Rare Disease Clinical Trial

Featured Editorial
Industry Insights
The Advantages Of Robotics In Aseptic Fill/Finish

As you move into a future of diverse pipelines that present both great opportunities and great challenges, consider utilizing a flexible solution such as robotics that can be rapidly implemented into your facility.

Intensified Chromatography Strategies

With a newer toolbox of options to intensify downstream manufacturing operations, it is important to understand what factors should impact decisions regarding the implementation of these solutions.

GMP-Source And Phase-Appropriate Use For Early-Stage Clinical Trials

GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.

A Changing World In Gene Therapy Research: Exciting Opportunities For Medical Advancement And Biosafety Challenges

In this report, key developments are highlighted in the field with a focus on biosafety. The report also provides guidance for performing risk assessments on currently approved gene therapy products as well as the most utilized types of investigational products in clinical trials.

High-Dimensional Cell Sorting Utilizing Real-Time Spectral Unmixing With The Bigfoot Spectral Cell Sorter

Cell sorters have lacked the technical sophistication to isolate cell types found in complex multicolor spectral panels and sort them in real time. By pairing the power of full-spectrum flow cytometry with real-time sorting to extend the frontiers of cell type discovery this technology can isolate cell types found in complex multicolor spectral panels and sort them in real time.

Achieving Cell And Gene Manufacturing Scalability: A Conversation With AVROBIO’s Geoff MacKay

Geoff MacKay, president and CEO of AVROBIO, talks on the Business of Biotech podcast about the scale-up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

Understanding The Gene Therapy Manufacturing Process

Gene therapy is the process of replacing damaged or unhealthy genetic material with new material for treating various diseases and conditions. Discover the gene therapy manufacturing process, including the steps and timelines.

Five Ways To Get To IND/IMPD Faster

How do you get to IND/IMPD without sacrificing quality and future commercialization goals? Read on for expert considerations for accelerating and optimizing your early development process.

Tips For Managing GMP Manufacturing Timelines

For cell and gene therapy developers, delays mean lost time and resources that can negatively impact the pathway to commercialization. For CDMOs, delays impact capacity and resource planning. CDMOs and their clients must work to understand and mitigate timeline risks for minimal impact on project success.

Multiplexing: Managing Risk With Proven, Single-Use Solutions

Instead of trying to make better predictions or erring on the side of overcapacity, developers and CDMOs should seek manufacturing flexibility.

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.

Manufacturing Innovation Across New Modalities

The successful outcomes delivered by cell and gene therapies, coupled with the emergence of modalities across nucleic acid therapeutics and microbiomes, pose the next challenge for innovators to make these new modalities available at scale.

Improve Quality And Yield For Viral Vector Manufacturing

Osmolality has long been considered a critical measurement in biopharma, describing how much of a solute is present in a given solution. It's increasingly applicable in cell and gene therapies. 

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