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Articles by Moria Feighery-Ross
07.10.24 -- Inside Next-Gen Platforms For Cell Therapy Manufacturing
Boost your gene therapy production with the VirusExpress® AAV Platform! Our transfection-based solution ensures high-yield, scalable adeno-associated virus (AAV) manufacturing with streamlined processes. Designed for efficiency, VirusExpress® AAV Platform reduces production costs while maintaining consistency and compliance with regulatory standards. Elevate your bioprocessing capabilities and accelerate your path to clinical success with our innovative solutions. Learn more.
05.01.24 -- Developing A Process Performance Qualification Master Plan
Take a virtual tour of one of the largest dedicated testing facilities for Cell & Gene Therapy and other Biologics here in the United States. Visit WuXi Advanced Therapies 140,000 ft2 modern and flexible testing laboratory in Philadelphia, PA, and discover your next partner for Assay Development, Biosafety Testing, Viral Clearance, and Commercial Lot Release. Learn more here.
01.15.24 -- Tackling 3 Challenges In Developing An Inhaled Gene Therapy
Cell & Gene Live welcomes Dr. Peter Marks, director, CBER, FDA, and Dr. Nicole Verdun, super office director, CBER, FDA, to discuss the evolving regulatory landscape in 2024 for cell and gene therapies. Join this interactive discussion as we cover improved communication with sponsors, increased speed availability through manufacturing processes and standards development, and much more. Registration is free thanks to the support of Thermo Fisher Scientific.
09.20.23 -- Takeda's Green Approach To IG Purification And Filling
4th Annual Biotech Startup Symposium We invite you to the 4th Annual Biotech Startup Virtual Symposium (November 14th-15th), a free, two-day event to help biotech start-ups navigate their path to commercialization. This symposium will feature industry experts who will present and discuss various aspects of emerging technologies and the latest trends in their fields. Learn more.
09.05.23 -- Is Your "Preferred Provider List" Legacy-Heavy?
A consistent challenge for cell and gene therapy developers is finding a CDMO with the right capabilities, capacity, and timeline to meet their project needs. If this scenario sounds familiar, don’t miss the final Outsourced Pharma Capacity Update of 2023. This multiday event is conveniently grouped by molecule type and will feature cell and gene CDMO capacity presentations on October 5th. Registration is free. Doesn’t an approved/preferred service provider list facilitate partner selection?
Qualification Considerations For A “Factory-in-a-Box”
By Moria Feighery-Ross and Wai Wong, Pharmatech Associates VIEW THE WHITE PAPER! Get unlimited access to: Trend and Thought Leadership Articles Case Studies & White Papers Extensive Product Database Members-Only Premium Content Welcome Back! Please Log In to Continue. X Enter your credentials below to log in. Not yet a member of ECM Connection? Subscribe today.
How To Reduce Costs And Risk For Cell & Gene Therapy Facilities
By Moria Feighery-Ross, CQA, CMQ/OE, senior consultant, Pharmatech Associates When it comes to cell and gene therapy (CGT) facilities, how will you save costs in construction, commissioning/qualification/validation (CQV), and ongoing operations? Compared to traditional pharmaceutical and biotech facilities, cell and gene therapy facilities are simpler, requiring fewer critical utilities and needing only a limited selection of specialized systems since many processes are small-scale and enclosed.
How To Reduce Costs And Risk For Cell & Gene Therapy Facilities Original
By Moria Feighery-Ross, CQA, CMQ/OE, senior consultant, Pharmatech Associates When it comes to cell and gene therapy (CGT) facilities, how will you save costs in construction, commissioning/qualification/validation (CQV), and ongoing operations? Compared to traditional pharmaceutical and biotech facilities, cell and gene therapy facilities are simpler, requiring fewer critical utilities and needing only a limited selection of specialized systems since many processes are small-scale and enclosed.
How To Reduce Costs And Risk For Cell & Gene Therapy Facilities
By Moria Feighery-Ross, CQA, CMQ/OE, senior consultant, Pharmatech Associates When it comes to cell and gene therapy (CGT) facilities, how will you save costs in construction, commissioning/qualification/validation (CQV), and ongoing operations? Compared to traditional pharmaceutical and biotech facilities, cell and gene therapy facilities are simpler, requiring fewer critical utilities and needing only a limited selection of specialized systems since many processes are small-scale and enclosed.
09.23.21 -- Gene Therapies for Spinal Cord-Related Diseases
By Moria Feighery-Ross and Wai Wong, Pharmatech Associates Cell therapy production is cost-prohibitive due to the limited manufacturing space and number of personnel required. Enter the "factory-in-a-box," which can be a game-changer for the industry. By Cell & Gene Karen Kozarsky, Ph.D., cofounder, and CSO of SwanBio, explains how the company is pioneering a deep and varied pipeline of gene therapies for genetically defined neurological diseases with a focus on the spinal cord.
07.21.21 -- What's Behind BridgeBio's 30+ Drug Candidates?
By Matthew Pillar, editor, Bioprocess Online Chief business officer Michael Henderson, M.D., opens up on the inner workings of academic partnerships that are driving an unusually large pipeline of therapeutic candidates across a broad range of modalities in the rare genetic pediatric disease space.
07.01.21 -- Cell & Gene Best Of June
By Kyle M. O’Neil and Brendan J. Wang, Back Bay Life Science Advisors What's ahead for gene therapy in the next decade? This article highlights six key questions and recommendations for the future of the industry. By Moria Feighery-Ross and Wai Wong, Pharmatech Associates The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required. Enter the factory-in-a-box.
06.17.21 -- Qualifications For "Factory-in-Box"
By Moria Feighery-Ross and Wai Wong, Pharmatech Associates The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive.
Qualification Considerations For A “Factory-in-a-Box” Original
By Moria Feighery-Ross and Wai Wong, Pharmatech Associates The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. A “factory-in-a-box” encloses the manufacturing of a product or process in an easily transportable container that requires minimal utility and environmental support.
Qualification Considerations For A “Factory-in-a-Box”
By Moria Feighery-Ross and Wai Wong, Pharmatech Associates The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. A “factory-in-a-box” encloses the manufacturing of a product or process in an easily transportable container that requires minimal utility and environmental support.
The Value Of Standardizing Risk Assessment Across Quality Systems
The Value Of Standardizing Risk Assessment Across Quality Systems In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely.
The Value Of Standardizing Risk Assessment Across Quality Systems
The Value Of Standardizing Risk Assessment Across Quality Systems In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely.
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