Developing Universal AAVs, Smart mRNAs, and Cell Therapies: Modernizing Cancer Treatment and Manufacturing
Cell & Gene
The most valuable resource for professionals who make their living in the cell & gene therapies industry.
TRENDING CONTENT - Catch Up
"Universal" isn't the first word most people think of when they think about AAVs. But what if there were such a thing? Siren Biotechnology 's CEO, Nicole K. Paulk, PhD , shares the story behind developing the company's universal AAV immuno-gene therapy.
KSQ Therapeutics, Inc. 's CSO, Micah Benson , Ph.D., joins Erin Harris to discuss how TILs?as a treatment modality have the potential to treat a variety of solid tumor types. Benson explains KSQ's Phase 1/2 clinical study, KSQ-001EX, which consists of TILs in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing.
Cell therapy manufacturing is a rapidly evolving field that presents new challenges. Creating a manufacturing roadmap can help your organization navigate through these challenges and act as a guide to automation implementation. This roadmap should be developed during the preclinical phase and will require ongoing refinement. Source: Invetech
Strand Therapeutics ' programmable, "smart," mRNA therapeutics could deliver precise, potentially curative treatments for solid tumors and hematological malignancies. CEO and Co-Founder Jacob Becraft joins Erin Harris to discuss genetic regulation and how the company's programmable mRNA constructs combine genes for self-replication derived from RNA viruses with genetically programmed logic circuits that control the location, timing, and intensity of expression of therapeutic proteins within the patient’s body, enabling precise and controlled delivery.
Business leaders can enhance quality control (QC) operations by adopting a holistic view of the quality ecosystem and embracing comprehensive modernization strategies. Explore the four principles being embraced by a growing number of business leaders for greater QC laboratory agility. Source: Veeva Systems
领英推荐
The FDA 's draft guidance on platform processes aims to simplify and accelerate product registrations, with a focus on emerging technologies like mRNA and LNPs. This could have significant implications for personalized cancer treatments, such as vaccines and CAR-T therapies, which are tailored to individual patients. The guidance may help standardize the complex manufacturing processes for these therapies, addressing challenges related to production timelines and regulatory compliance. This could foster innovation and improve outcomes in personalized medicine.
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“Personally, I get very excited about gene editing but that really is just one piece of the puzzle. You need the delivery vector to help get it to the cells of interest.”? Mammoth Biosciences ’ Lucas Harrington discusses the crucial points of practicality necessary for successful CRISPR systems.
CELL & GENE LIVE! - Register Now
Since the first CAR-T cell therapy approval in 2017, the industry has exploded with companies and candidates aiming to be the best. With each CAR-T that enters the clinic (and subsequently, the market), the modality matures — best practices are established, lessons are learned (sometimes the hard way), and technology evolves, challenging the industry’s idea of what’s possible. As CAR-T cell therapies evolve alongside technology, so does the way these therapies are manufactured. While centralized CAR-T manufacturing is the industry standard, some folks believe the future of CAR-T manufacturing will be decentralized, taking place at or near patients’ point of care (POC). Others think POC manufacturing won’t ever fully replace centralized manufacturing — that it’s not scalable and is laden with quality control and regulatory challenges.?
Join our speakers (Tyler Menichiello, Jason Bock , Emily English , & Tal Salz ) on Cell & Gene Live on Tuesday, August 27, at 11 AM EDT. as they discuss the ways CAR-T manufacturing has advanced in recent years, as well as where it’s going.