Newsletter | April 2, 2024

04.02.24 -- 2024's Market Outlook For Cell & Gene Therapies

SPONSOR

Webinar: Safety At The Center – The Synergistic Role Of Drug Safety In Clinical Trial Operations

In drug safety and pharmacovigilance, collaboration isn’t just a buzzword — it’s an essential component that can impact patient safety and the success of your product. Join us in this webinar as we highlight the importance of effective interpersonal leadership in your drug safety program and reveal the operational and financial efficiencies that can result from a collaborative dynamic. Click here to learn more.

FEATURED EDITORIAL

2024’s Market Outlook For Cell & Gene Therapies

RSM is back for the third consecutive year to provide an outlook analysis of the cell and gene therapy market. This article discusses the 2024 state of the macroeconomy, its effects on cell and gene therapy companies, growing approval pipelines and approvals, funding factors, and the unique prospects for the market.

Creative Outsourcing Strategies, But Fill/Finish Still A Concern

Chief Editor Louis Garguilo wraps up his discussions with Thomas Rademacher, CEO, Emergex Vaccines, focusing on strategies that mix internal capacity, facility purchases, CDMOs, new technologies, and challenges with fill/finish outsourcing.

INDUSTRY INSIGHTS

Plasmid DNA And Advanced Therapies: Accelerating Path To Clinic

Examine the challenges CGT innovators face and how adhering to GMP requirements from the early stages helps to ensure successful downstream applications from early clinical development to commercial phase.

mRNA/saRNA Manufacturing RNA Production And Manufacturing

Venkata Indurthi, Ph.D., discusses key considerations for the production of RNA and strategies for successful scaling for commercial manufacture. Learn more about messenger RNA and self-amplifying RNA manufacturing processes.

Scale Up Strategy For Oncolytic HSV-1 Vector Manufacturing

Discover how a novel, large-scale production method for herpes simplex virus type-1 (HSV-1) vectors has the potential to accelerate the progress of gene therapy and bring it closer to widespread application.

Insights Into GMP Manufacturing Of RNA-LNP Drug Products

Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, facility design, and strategic collaborations.

The Changing Vaccine Development Landscape

Review the different technologies that are being used to develop next-generation vaccines and the challenges and opportunities that these technologies present.

NEW PODCAST EPISODE

Reducing Toxicities in Allogeneic Cell Therapies with Orca Bio's Dr. Scott McClellan

Orca Bio's CMO, Dr. Scott McClellan, joins Cell & Gene: The Podcast to discuss how and why toxicities continue to stymie allogeneic cell therapies. Learn about the company’s plan to potentially lower the risk of GvHD as well as Orca-T, the investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Listen now and subscribe so you never miss an episode!

SOLUTIONS

A Transformative Journey From Research To Large-Scale Production

Learn about MilliporeSigma's journey to becoming a leader in clinical and commercial viral vector manufacturing and their support of cell and gene therapy innovators since the industry’s beginnings.

A New Player With A Long History

Leveraging more than 15 years in the field, Andelyn Biosciences provides custom development and manufacturing of AAV vectors for gene therapy as a full-service concept-to-commercialization cGMP CDMO.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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