Newsletter | November 4, 2025

11.04.25 -- Best Practices For Program Manager Alignment And Integration When Working With A CDMO

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Leave No Gap in Your Adventitious Agent Testing (AAT) Strategy

Revolutionizing the development and analysis of biologic therapeutics, Next Generation Sequencing (NGS) allows you to meet the challenge of rapidly characterizing your products, while identifying known and unknown agents with pinpoint precision and accuracy. Read this paper and explore the use of NGS for adventitious agent detection in cell banks.

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Program Manager Alignment And Integration: Best Practices When Working With A CDMO

This Q&A discusses best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders.

Getting To The Heart Of CDMO Tech Transfer Excellence

Learn five key factors that drive a seamless technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success in the CDMO industry.

Super Short Activated CAR-T Process

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

Virtual Quality Audits — Serving Biopharma's Future

A properly executed virtual audit facilitates thorough qualification, condenses production timelines, enhances relationship-building, and provides early insight into a CDMO’s capability and expertise.

Integration Of Container Closure Integrity In Contract Manufacturing

Maintaining drug product sterility and compliance demands rigorous Container Closure Integrity (CCI) within contract manufacturing. Learn how to fortify your processes.

Achieving Rapid, High-Titer Expression For Next-Generation Biologics

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

Leveraging The Right RNA Polymerase Enhance Capping Efficiency

By utilizing an engineered co-transcriptional capping RNA Polymerase, researchers can reduce the production of double-stranded RNA byproducts and enhance the functionality of mRNA therapeutics.

Optimized Transient Production: Faster Preclinical Studies With Enhanced QC

Accelerate your path from discovery to clinic by leveraging high-quality plasmid DNA, optimized expression systems, and early developability assessments to streamline transient protein production.

Extractables And Leachables: Setting Up Early For Success With Your CDMO

Discover insights tailored specifically for drug product researchers and manufacturers, offering key knowledge on extractables, leachables, and effective implementation strategies.

Enabling The Rapid Delivery Of Stable, High-Producing Cell Lines

Leveraging Abzena’s deep expertise in biologics development and supported by our comprehensive analytics suite, AbZelectPRO™ streamlines the IND application pathway, ensuring smooth progression into clinical phases.

A Two-Part Strategy To Streamline The Path To FIH

In cell line development, application of targeted integration cell line technology boosts development speed. Then, a proven production platform facilitates seamless scaleup to GMP manufacturing.

Accelerating Development With Rapid Delivery Of Toxicological Study Material

Explore key strategies and technologies designed to address the analytical considerations and material flows to facilitate the rapid delivery of toxicological material.

Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids

Standardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.

Successfully Producing Insoluble Proteins Using Inclusion Bodies

Review the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.

Integrated Manufacturing To Mitigate CMC Risks, Simplify Commercial Supply

Leveraging cross-functional coordination between sites, harmonized tech transfers, one quality system, and synchronized team activities can help deliver high-quality commercial outcomes.

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Webinar: Driving Robust Tech Transfer in Biologics: Computational Fluid Dynamics (CFD) Simulation

Biopharmaceutical scale-up success depends on understanding how process conditions impact product quality. Join Samsung Biologics to explore how Computational Fluid Dynamics (CFD) enhances Quality by Design by modeling key parameters like mixing, shear, and oxygen transfer. Learn how virtual experimentation accelerates tech transfer, strengthens process robustness, and drives smarter, risk-based decisions in bioprocess development. Click here to learn more.

OUTSOURCING SOLUTIONS

Contract Services To Optimize Continuous Nanoparticle Processing - DIANT Pharma

Global Experts In Nanotechnology And Drug Particle Engineering - Nanoform

Organoid-Based Drug Screening Services - Samsung Biologics

R&D CDMO Services - Cytovance Biologics

Seattle CDMO Site Takes On The Complex Molecules - AGC Biologics

Global Network For Mammalian Cell Culture Manufacturing - Boehringer Ingelheim Biopharmaceuticals GmbH

Biologics Analytical Services - Catalent

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