CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

  • Managing Risks To Time Critical Product Imports At Clinical Supply Depots
    Managing Risks To Time Critical Product Imports At Clinical Supply Depots

    Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.

  • Cell Therapy Manufacturing Under GMP - How And When To Get Started
    Cell Therapy Manufacturing Under GMP - How And When To Get Started

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

  • Cancer in the Age of Long Noncoding RNA Discovery
    Cancer in the Age of Long Noncoding RNA Discovery

    The coming years will be an exciting era in genetic research as we discover new biological mechanisms and functions for noncoding RNAs. Our improved understanding of this class of genes should provide insight into novel treatments for cancers.

  • Jumpstart Cell & Gene Therapy Commercialization With SUT Learning
    Jumpstart Cell & Gene Therapy Commercialization With SUT Learning

    Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. 

  • Consistent Cord Blood Cryopreservation
    Consistent Cord Blood Cryopreservation

    Freezing cells without liquid nitrogen

  • Intracellular Flow Cytometry Tips And Tricks
    Intracellular Flow Cytometry Tips And Tricks

    Helpful tips such as carefully choosing the most suitable fixative and permeabilization reagents as well as other factors that should be considered when designing intracellular flow experiments.

  • Multiplex Cytokine Immunoassays — Minimizing Effort, Maximizing Results
    Multiplex Cytokine Immunoassays — Minimizing Effort, Maximizing Results

    The availability of commercial multiplex cytokine assays enables end users to interrogate an entire network of cytokines in a single sample.

  • Closed And Semi-Automated Processing Of CAR T Cells
    Closed And Semi-Automated Processing Of CAR T Cells

    Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.

  • Reliable Single-Cell Sorting  With Bio-Rad’s S3e ™  Cell Sorter
    Reliable Single-Cell Sorting With Bio-Rad’s S3e ™ Cell Sorter

    A demonstration of a simple workflow to verify the reliability of the S3e Cell Sorter in sorting single
    cells. Using this method, a confirmed sorting accuracies of >94% and 100% for single cells and single beads is achieved, respectively.

  • Cell & Gene Therapies: SUT Connection Lessons From Biotech
    Cell & Gene Therapies: SUT Connection Lessons From Biotech

    Single use connection technologies are expected to play a critical role in commercial manufacturing of cell and gene therapies. Learn about the types of connection technologies and selection considerations.

More Articles, App Notes, Case Studies, & White Papers
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  • Part 2: Adaptimmune’s Deep Dive into Manufacturing & Process Development
    Part 2: Adaptimmune’s Deep Dive into Manufacturing & Process Development

    In Part 1 of our two-part series with Adaptimmune, CEO James Noble, who has announced his retirement since the publication of this article, provided thoughtful insight on the status of combatting solid tumors as well as the ongoing pricing issue affecting the cell and gene therapy sector. Here in Part 2, along with John Lunger, SVP, Manufacturing and Supply Chain, and Mark Dudley, SVP, Product Development at Adaptimmune, we dig deeper into the topics discussed in Part 1 — we shed granular light on how pricing will affect manufacturing; we talk outsourced versus in-house manufacturing and more. 

  • Orchard Therapeutics Tackles ADA-SCID, MLD, And Much More
    Orchard Therapeutics Tackles ADA-SCID, MLD, And Much More

    On the heels of our sister print publication, Life Science Leader’s cover story on the whirlwind rise of Orchard Therapeutics, I had the opportunity to talk to company’s Co-Founder and Chief Scientific Officer, Dr. Bobby Gaspar about how the company has developed innovative gene therapies to treat CNS diseases, such as metachromatic leukodystrophy (MLD), tackle ADA-SCID, and more.

  • Expected Outcomes Of Minovia Tx’s MAT Clinical Trial
    Expected Outcomes Of Minovia Tx’s MAT Clinical Trial

    Minovia Therapeutics recently announced dosing of the first patient in a Phase I/II clinical trial of the company’s Mitochondrial Augmentation Therapy (MAT) for the treatment of Pearson syndrome. As stem cell transplantations and cellular therapies continue to gain momentum rapidly, this is an example of trial that could pave the way for the development of treatments for all mitochondrial diseases.

  • Breaking Down Pricing Of Cell & Gene Therapies
    Breaking Down Pricing Of Cell & Gene Therapies

    Erin Harris, Editor-In-Chief, Cell & Gene conferred with several SMEs in the cell and gene sector to get their take on the challenges for both industry and patient associated with cell and gene therapy prices, and what can be done, realistically, to bring costs down over time.

  • Adaptimmune’s CEO On Pricing And Next-Gen Immuno-Oncology
    Adaptimmune’s CEO On Pricing And Next-Gen Immuno-Oncology

    James Noble, CEO of Adaptimmune, explains where the industry is with attacking solid tumors and sheds light on the ever-present pricing issue.

  • Cell & Gene Appoints New EAB Member
    Cell & Gene Appoints New EAB Member

    Cell & Gene is committed to judiciously developing our best-in-class Editorial Advisory Board (EAB). Cell & Gene’s EAB is diverse and interactive, and members hail from both industry and academia. We’re pleased and honored to announce our newest member of Cell & Gene’s Editorial Advisory Board — Vijay Chiruvolu, SVP of Global Process Development, Cell Therapy at Kite Pharma.

  • Dr. Aaron Levine On FDA’s Statement About Dubious Stem Cell Clinics
    Dr. Aaron Levine On FDA’s Statement About Dubious Stem Cell Clinics

    Last month, the FDA released a statement by former FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk. I caught up with Dr. Aaron Levine, Associate Professor, School of Public Policy, Georgia Institute of Technology to get his take on the statement and how dubious players affect the good of the cell and gene sector.         

  • Why Is Indication Crowding A Concern?
    Why Is Indication Crowding A Concern?

    Just recently, I interviewed Dr. Reni Benjamin, Managing Director, Biotechnology Equity Research at Raymond James & Associates about the panel he moderated at ARM’s 2019 Cell & Gene Therapy Investor Day. In the article, Dr. Benjamin explained how investors are thinking about the cell and gene therapy space in 2019.

More Erin’s Latest Columns

CELL & GENE INDUSTRY EVENTS

FDA's eCTD Ad-Promo Guidance Is Finalized: Are You Ready? August 7 - 7, 2019
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error August 8 - 8, 2019
1pm-2:30pm EDT, Online Training
Cleanroom Guangzhou Exhibition August 16 - 18, 2019
Guangzhou
Lyophilization - An Introduction to the Scientific Principles August 27 - 27, 2019
1pm-2:30pm EST, Online Training
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