Newsletter | February 18, 2025

02.18.25 -- From JP Morgan: CDMOs Have A Change Of Heart

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Webinar: Who’s In Charge of Your Trial? How to Ensure Effective Oversight and Leadership

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FEATURED EDITORIAL

From JP Morgan: CDMOs Have A Change Of Heart

CDMOs seem determined to do two things more strategically and with a greater focus: build on what they do best (instead of spreading across services); and differentiate themselves by a devotion to customer service. Part two from JPM25.

New AAV Reference Standards To Aid CQA Assessment

Adeno-associated virus' (AAV) complexity makes them difficult analytical testing subjects. The second part of a series describes USP's latest effort to help characterize the viral vectors.

INDUSTRY INSIGHTS

Analytical Comparability Of 5 Alternative AAV9 Downstream Processes

Explore how two-column AAV processes can enhance yield and potency while maintaining high-quality standards in the production of gene therapy products.

Overcoming Challenges: Optimize And De-Risk Your mRNA Product Manufacture

mRNA therapy and vaccine manufacturing can be complex when working with multiple CMOs, making partnering with an end-to-end CMO essential to overcoming these challenges.

The High Cost Of Going Cheap

Developers often aim to cut expenses during development. Discover the long-term outcomes of cost-effective measures like using RUO leukopaks compared to investing in high-quality GMP-grade vectors.

A Focus On Cell Therapy: CAR-T, CAR-NK, And Beyond

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

Successful Clinical Manufacturing: Getting The A Team In Place

Certain roles must be filled before you move into manufacturing to avoid costly delays and incur non-value-added expenses. Uncover what those roles are and get ideas on how to fill them.

Overcome Scale-Up Hurdles For Adenovirus-Based Vaccine Manufacturing

Learn about the development and effective scale-up of a robust process for manufacturing adenovirus vectors and the obstacles that were encountered and successfully overcome.

Validation Of Capsid Titer And Host-Cell DNA Impurity Assays For rAAV QC

This study introduces validated methods for quantifying AAV9 capsid titer and host-cell-derived impurities, offering a solution for enhancing rAAV batch release testing.

Engineering CHO K1 Cells With Three Orthogonal Transposase Systems

Transposase-mediated genome engineering enables the robust and stable relocation of discrete DNA segments (transposons) in the genome, providing a valuable tool for stable transgene expression.

RNA Nanoparticle: Formulation, Process, And Characterization

As the field grows, understanding how to formulate RNA nanoparticles effectively is essential for advancing therapeutic innovations.

Scalability Of A Flexible, High-Producing Triple-Transfection rAAV Platform

Review a demonstration of a scalable, high-yield triple-transfection rAAV platform's efficiency, enabling gene therapy production with strong performance and streamlined processes.

Mastering The Journey From Initial Method Transfer To Successful Lot Release

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

DoE Identifies Viable-Cell Density, DNA Amount As rAAV Productivity Factors

See how a Design of Experiment (DoE) model was applied to address the multifactorial nature of large-scale transfection, where multiple variables collectively impact efficiency.

Ready-To-Use Nested Vial In Tub: New Design And Packaging Configuration

With the increasing demand for cell and gene therapies, CZ nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.

SOLUTIONS

Accelerate Development With Large-Scale mRNA And LNP Production

Achieve scalable purity with Vernal Biosciences' mRNA and LNP production, tailored for preclinical studies, dose range finding, and toxicology assessments.

De-Risked Lentivirus Production Through Experience

With nearly three decades of viral vector expertise, we offer a scalable, efficient solution to de-risk lentivirus production.

Tools For Developing Successful Biologics: XS® Pichia Expression System

The XS® Pichia Expression System allows you to develop scalable, robust, and reliable processes to express your biologics drugs with improved productivity.

Gene Editing Services That Ensure Quality, Accuracy, Fast Turnaround Times

Choose from our technology platforms or have our scientists customize a project using our patented RACE™ protocol for quality, accuracy, and fast turnaround.

Analytical Control Strategy For Your Product Lifecycle

Our team has decades of cell and gene therapy development experience and can help you achieve maximum return on investment.

Services For Advancing mRNA-LNPs From Bench To Clinic

Consider our one-stop shop for LNP technologies that provides access to expertise in formulation and analytics for successful outcomes for payload and target applications.

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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