Newsletter | August 20, 2024

08.20.24 -- Power Of Attorney For Cell Therapy Outsourcing

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FEATURED EDITORIAL

Power Of Attorney For Cell Therapy Outsourcing

“I always say I’ve brought a little New Jersey litigator to Pittsburgh biotech,” says BlueSphere Bio CEO Keir Loiacono. And to the CDMOs he works with. Today, his attorney-informed focus is applied to T cell receptor (TCR) technology. Here's part one of his unique insights to outsourcing.

July 2024 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

INDUSTRY INSIGHTS

Why Partner Communications Are Key For Autologous Cell Therapy Trials

The dynamic nature of complex cell therapy-focused clinical trials requires individuals with a keen understanding of site and partner needs communicating effectively.

Identifying The Right Analytical Strategy For AAV Production

AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.

Key Challenges In mRNA Manufacturing

Manufacturing mRNA products is a complex and challenging process that requires careful consideration at each stage. Learn more about the challenges and intricacies involved.

Mastering The Journey From Method Transfer To Successful Lot Release

View the webinar and learn how efficient project management and optimized communication are cornerstones of a successful transfer process.

How Outsourcing RNA-LNP Production Can Have A Competitive Advantage

Manufacturing RNA-containing LNPs demands specialized expertise  Explore the challenges of RNA-LNP manufacturing and the advantages of outsourcing RNA-LNP formulations.

Setting Expectations For Post-Thaw Segment QC Testing On A CBU

Examine the post-thaw segment QC results for 2,249 consecutive segments cut at our institution to create a benchmark of what is to be expected when interpreting segment testing.

Optimizing End-To-End Contract Analytical Support For CGTs

The development and production of CGTs present unparalleled complexities. Learn how a partner with robust end-to-end services can help you overcome challenges at every step of the drug lifecycle.

Addressing Complex Challenges And Developing Innovative Solutions

Explore two projects that a focus on improving efficiency and productivity in manufacturing while reducing the cost of goods through process intensification.

Biotechnology: The Key To America's Next Manufacturing Revolution

Learn how a recent expansion into Western Pennsylvania is aiming to enable more biopharmaceutical firms to translate cutting-edge science and research into practical applications.

SOLUTIONS

Expertise, Experience, And Commitment Drives Results

Our team of experienced engineers, scientists, researchers, analysts, and operators have expertise in a variety of modalities, equipment, technologies, platforms, and processes. 

GMP mRNA And LNP-mRNA Manufacturing

We offer GMP services with detailed process characterization. Your project will benefit from the heavily documented quality-by-design program that surrounds the development of our platform GMP process and analytical methods.

Codex HiCap RNA Polymerase

Codex HiCap RNA Polymerase delivers enhanced safety, cost-effectiveness, and performance, empowering researchers to unlock the full potential of mRNA therapeutics.

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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