Below is a selection of industry articles that may be helpful in understanding today's gene therapies and the need to commercialize these critical health innovations.
Digital Droplet PCR for Viral Vector Analysis
by Richard Snyder, Ph.D., Diego Matayoshi, Susan D'Costa, Ph.D., and Sushma Ogram, Ph.D.

"Polymerase chain reaction (PCR) is an essential tool for the analysis of therapeutic viral vectors used in cell and gene therapies. Digital droplet PCR (ddPCR) offers significant advantages over other qPCR methods, allowing for absolute, rather than relative, quantification of the target DNA molecules present in a sample, which is critical to a range of analytical assays necessary for viral vector production and characterization. Brammer Bio is leveraging this technology to obtain more precise and accurate analytics for a variety of viral vectors."

 

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From Proof of Concept to Commercialization
a Q&A with Mark Bamforth and Richard Snyder, Ph.D.

"Nice Insight sat down with Brammer Bio’s cofounders Mark Bamforth, Chief Executive Officer, and Richard Snyder, Chief Scientific Officer, to discuss the evolution of the viral vector marketplace and how Brammer Bio is investing to support the commercial development of the next generation of gene and cell therapies.

 

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Analytical Methodologies Utilized in Therapeutic Viral Vector Manufacturing
by Richard Snyder, Ph.D., Sushma Ogram, Ph.D., and Tony DeFusco

"Expertise in a wide variety of analytical techniques is required for the detection and characterization of the protein and nucleic acid components of viral vector products and any impurities. Analyses of process- and product-related impurities are performed to ensure the manufacture of high-quality therapeutic viral vectors. In many cases, customized assays must be developed. CDMOs that can provide innovative, rapid, and robust analytical methods provide a competitive advantage to their clients."

 

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Overcoming Raw Material and Supply Chain Challenges in Viral Vector Manufacturing
by Richard Snyder, Ph.D., Christopher Murphy, Susan D’costa, Ph.D., and Cameron Jones 

"Viral vector manufacturing presents numerous challenges. In addition to developing practical commercial-scale processes, raw material sourcing and management of the supply chain are crucial. Access to high-quality raw and starting materials, from cell lines and serum to excipients and single-use components, is key. Risk assessment and management with appropriate testing, vendor qualification and supply chain transparency are essential to establishing security of supply."

 

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Ensuring Confidence in Viral Vector Manufacturing
by Christopher Murphy and Michael Wourms

"Cell and gene therapies are rapidly advancing to late-stage clinical trials and commercialization. Brammer Bio has expanded its capabilities to meet the growing need for flexible, high-quality advanced viral vector development and manufacturing services with an emphasis on providing the highest level of patient safety and reliability."

 

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Transient Transfection at a Large Scale for Flexibility in Clinical and Commercial Vector Manufacturing
by Richard Snyder, Ph.D., Scott Jeffers, Ph.D. and Ying Cai, Ph.D.

"The rapid progress of cell and gene therapies through clinical development is driving demand for late-stage clinical and commercial manufacturing capabilities. Transient transfection for vector production offers significant flexibility
for cell and gene therapy development."

 

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Manufacturing Clinical Grade Recombinant Adeno-Associated Virus Using Invertebrate
Cell Lines
by Robert M. Kotin, Ph.D. and Richard Snyder, Ph.D.

"Recombinant adeno-associated virus (rAAV) vectors are proving to be a reliable gene transfer system for
several clinical applications, with an increasing body of evidence supporting safety and efficacy."

 

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Supporting the Tech Transfer Continuum for Cell & Gene Therapies  
by Jessica Tate, Ph.D., Matthew Caple, and Richard Snyder, Ph.D.

"As growing numbers of biopharmaceutical companies experience clinical success with new cell and gene
therapies, they are satisfying their development and manufacturing needs in collaboration with contract
service providers."

 

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Next-generation therapies: overcoming bioprocessing, characterization and logistics challenges by Cynthia A. Challener, Scientific Content Director, That’s Nice, LLC

"Initial clinical successes in a wide variety of indications and commercial launch of three cell and gene therapy products have driven significant investment in these next-generation technologies. Both large bio/pharma and start-up companies are eager to advance beyond early clinical trials to Phase III and commercial."

 

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Designing a Better Single-Use Facility
by Carl Carlson

"With the right tool, single-use facility design can benefit from a proactive review of facility, systems, design intent and risk...Although single-use, disposable technologies (SUTs) have been around for decades, continued development and implementation of this innovative process technology is needed to help accelerate the advancement  of biopharmaceutical drug development."

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Achieving Large-Scale Cell and Gene Therapy Manufacturing
by Richard O. Snyder, Ph.D., Mark R. Bamforth and Steven Kasok

"Initial clinical successes with cell and gene therapies have driven significant investment in these next-generation technologies . . . Many of these companies are eager to advance beyond early clinical trials to phase III and commercial products, but lack the manufacturing capability."

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Investing for Successful Advancement of Viral Vector Manufacturing
by Richard O. Snyder, Ph.D. and Mark R. Bamforth

"The gene therapy sector is experiencing phenomenal momentum, with many new companies being formed, the number of clinical trials expanding, and growth in the number of products poised for commercialization."

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CDMOs Crucial for Bringing Promising Next-Generation Therapies to Market
by Richard O. Snyder, Ph.D. and Mark R. Bamforth

"The success of next-generation gene and modified cell therapies in early clinical trials is generating significant excitement in the pharmaceutical industry. Patients and investors are applying pressure on developers to get treatments to market as quickly as possible."

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Please note: Brammer Bio assumes no responsibility for information obtained through hyperlinks or references to other websites obtained on our website, and is not liable for any damages or injury arising from the content of such other websites.

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