Newsletter | February 4, 2025

02.04.25 -- An Outsourcing Vibe At JP Morgan 25

SPONSOR

Webinar: From Research to Reality: Overcoming CMC Challenges in Cell & Gene Therapy

Join us on February 20th to learn how to overcome manufacturing and regulatory challenges in cell and gene therapy by developing robust CMC strategies, employing Quality by Design, and implementing phase-appropriate GMP processes. This webinar is ideal for small biopharma companies and institutions seeking to bridge research and commercial development effectively. Click here to learn more.

FEATURED EDITORIAL

An Outsourcing Vibe At JP Morgan 25

The JP Morgan Healthcare conference has never been a venue for directed discussion on outsourcing. That’s not to say such discussions aren’t held. This year, Kurt Nielsen co-hosted an evening devoted to the topic. Nielsen, a veteran outsourcing-industry executive, shares his initial thoughts on the vibe this year.

Building Frameworks To Support Complex Therapy Manufacturing

To make its clinical product, CLBR001+SWI019, the Calibr-Skaggs Institute for Innovative Medicines relies on a complex network of contractors from around the globe.

One Percent Of A Hundred People's Efforts

Persephoni BioPartners CEO Hilary Shultz, and newly hired Chief Scientific Officer William Heath – a 34-year veteran of Eli Lilly – explain their biotech-forming business model, dubbed a venture studio, and provide sound advice on working with CDMOs.

INDUSTRY INSIGHTS

Accelerated Development: Gene Therapy Vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

Exploring The Cost Considerations Of Immune Cell Therapies

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

Virus Filtration: Regulations And Mechanisms

In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.

Why Choosing The Right CDMO Partner Is Essential In Today's Market

Examine why it is essential for biotechs to choose the right contract development and manufacturing partner for drug development success in this market landscape.

Avoiding Manufacturing Challenges For GMP Plasmids With Unstable Sequences

Consistent replication and sequence retention of plasmid DNA is crucial for the efficiency and cost-effectiveness of AAV gene therapy and mRNA vaccine production.

Streamlining Tech Transfer: Balancing Early-Stage Needs With Future Success

Quickening the tech transfer process is a key variable in shortening development timelines and controlling costs, maximizing a molecule's potential for late-stage success.

AAV Analytics: Key Considerations When Developing A Clinical Program

Finding partners with the necessary skills to optimize AAV processes is crucial for minimizing risk. Explore key considerations for advancing your therapy from concept to commercialization.

Enhancing The Upstream Performance Of AAV Vector Manufacturing

Unlock the potential of AAV manufacturing by leveraging data-driven insights and the advanced Pro10™ platform to optimize processes, enhance productivity, and drive innovation in cell and gene therapy.

Beyond CRISPR: Next-Gen Gene Editing With TARGATT, Mad7, Base Editing

Consider several groundbreaking gene editing technologies — TARGATT®, Mad7, and Base Editing — and gain insights into their applications in genetic engineering and therapeutic development.

Reflecting On 2024: A Year Of Groundbreaking Achievements

Partner with us to drive life-changing therapies forward and support families worldwide with innovative supply chain solutions for life sciences.

End-To-End Analytical Solutions For Biologic Development

Gain access to comprehensive, state-of-the-art analytical services that ensure quality, safety, and regulatory compliance throughout every stage of your biologic drug’s lifecycle.

Fast-Track Development Of MSC-Based Cell, Extracellular Vesicle Therapies

Mesenchymal stem cell (MSC) development is accompanied by several challenges related to characterization, compliance, and balancing upstream and downstream development considerations.

SOLUTIONS

Take The Next Step In Your mRNA Product Journey

Learn how a collaborative approach significantly mitigates risk associated with mRNA product manufacturing and fosters greater agility and speed throughout the development process.

There's No Substitute For Deep Analytical Experience

By focusing on precision and quality, we aim to ensure that every therapeutic product meets the highest safety benchmarks, ultimately contributing to more successful treatments for patients in need.

What We Do To Help You

We're your partner in AAV vector design, manufacturability, scale-up, and quality assurance, ensuring product quality from pre-clinical phases to market, and maximizing positive impacts on patients.

Helping Cell Therapy Innovators Bring Treatments To Market

Cell therapies hold immense promise, but navigating the development process can be daunting. A strategic partner can bridge the gap between early-stage innovation and successful commercialization.

Capacity Update October 2024: Cell & Gene Therapy

With over 30 years of GMP manufacturing expertise, we offer dedicated capacity for clinical and commercial gene therapy batches, using advanced AAV platforms and proprietary cell lines.

Daikyo Crystal Zenith (CZ) Ready-To-Use Nested Vials

West presents CZ vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.

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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