Newsletter | June 23, 2022

06.23.22 -- How to Use RWE for Access to CGTs

 
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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.

Rapid Microbiologic Methods Aid In The "Race To Release" Challenges Of Cell And Gene Therapy Manufacturing

Examine how RMM differs from traditional microbiologic methods that rely on lengthy incubation periods and understand why there is a shift favoring RMM for pharmaceutical manufacturing.

Gap Analysis: How Objective Review Benefits Biopharma Clinical Quality Systems

A comprehensive gap analysis examines documented procedures, SOPs, and QMS processes, but also includes discussions with key personnel and scrutinizes outputs derived from those SOPs and processes. Learn about the “report card” — an independent key deliverable that helps the organization identify, prioritize, and remediate potentially problematic areas.

Reducing Cost Of Goods For Gene Therapy

Frost & Sullivan's Virtual Think Tank brought together leading minds to discuss key challenges and other insights related to reducing the cost of goods (COGs) for gene therapy.

Trends In Cold Chain Storage For Biologics

Packaging is critical as biotechnology products become more valuable and require colder storage.

Current And New Technologies To Characterize Advanced Therapies: Making The Right Decisions Upstream To Ensure Downstream Success

Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.

How To Build A Robust Packaging Strategy For Rapid Commercialization

Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

Genome Integrity Analysis Of AAV Using Multi-Capillary Gel Electrophoresis

We demonstrate that multiple AAV samples with different serotypes or different genome sizes can be run simultaneously on the multi-capillary system to accelerate the execution of sensitive AAV genome integrity analysis.

A Platform Standard For Viral Vector Manufacturing And Commercialization

Learn more about platform technologies that are being developed and implemented to support large-scale production of viral vectors.

Rapid Characterization Of Impurities

Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

From Old Adversaries To RegenMed Housemates: The 2-Billion-Year Story Of Mitochondria Transfer Via MSCs
Like the ancient purple bacteria and archaebacteria, multiple scientific, medical, and biotech disciplines might need to engage in a little bit of “symbiosis.” The benefits of kickstarting this endeavor will surely be energizing, not merely for regenerative medicine but, most of all, for patients in need.
Exploring FBX-101 For Krabbe Disease

Krabbe disease is a devastating neurodegenerative disease inherited in an autosomal recessive manner. Learn more about this disease and FBX-101, which utilizes adeno-associated viral (AAV) gene therapy.

Prepping For Commercialization Through Supply Chain Logistics

Cell and gene therapies (CGT) are bringing new hope to patients experiencing rare and serious diseases. And they are disrupting the biopharma market in new and challenging ways.

White Paper: Understanding The 505(b)(2) Approval Pathway

Explore how the 505(b)(2) regulatory pathway can help drug developers gain approval for new drugs in a fraction of the time and cost required by traditional paths.

The Guide To Electronic Consent

In this paper, delve into how eConsent is changing the informed consent process for clinical trial sponsors and participants.

How Syringe Filtration With Integrated Prefilter Technology Improves HPLC Performance And Throughput

In this article, we review how particulate removal through filtration effects column life and how to handle difficult to filter samples.

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