Newsletter | October 8, 2024

10.08.24 -- Team Topologies For Outsourced CMC Development

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Now available on demand! Choosing the right CDMO for antibody development is crucial. The wrong partner can lead to delays and quality issues, while the right one can streamline development and improve commercialization success. Join Outsourced Pharma's expert panel on CDMO selection for biologic drug developers, where experts will discuss qualification processes, partnership management, team and facility compatibility, and how to leverage your CDMO's strategic expertise.

FOCUS ON OUTSOURCING

Team Topologies For Outsourced CMC Development

When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.

Utilizing Integrated Cell Line Development With High Producing Stable Pools

Explore how an integrated CLD approach, combined with cutting-edge technologies, can drive program success and accelerate the development of protein-based therapeutics.

Bacteria Media Optimization Using In Silico Strategies

Determining ideal media composition for a bacteria is critical because it fosters a satisfactory grow rate, allowing the bacteria to reach the required growth yield.

Bispecific Antibodies: Navigating From Design To Market Success

The design of bispecific antibodies requires a comprehensive assessment that takes the following aspects into account: half-life, mechanism of action, and manufacturing challenges like impurities and low yield.

From Nanoformed Powder To 3D Printable Ink

3D printing in pharmaceutics is advancing to offer innovative drug delivery applications. Explore the possibilities of forming stable suspension in printing ink from nanoformed materials.

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.

Is Your Biologic At Risk For Protein Aggregation? Part 1

This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.

Optimizing Scale-Up Of AAV Gene Therapy In Upstream Processing

Explore more detail on how to achieve a 2000L scale-up and studies that have been optimized through process characterization and experimental approaches to better understand key process steps.

Mastering Manufacturing Challenges: Lessons From A CDMO's EUA Project

Review a CDMO's strategy for overcoming challenges when acquiring new equipment for an Emergency Use Authorization (EUA) project and how leveraging existing resources and collaboration was key.

Development And Optimization Of Suspension-Adapted 293T Cell Line

Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

Managing Outsourcing For Complex Formulations

Despite the growing body of research and scientific knowledge, perhaps the biggest challenge with LNP formulation is the journey into the unknown.

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.

The Path To Self-Administration: Moving From PFS To Auto-Injector

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

CMO As Partners For ADC Process Development, Scale-Up, Optimization

ADC programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.

Maximize Starting Material Consistency

By implementing an efficient characterization strategy, researchers can enhance the consistency of allogeneic cell therapy starting material, ultimately leading to improved clinical outcomes.

Pharma Manufacturing Strategies For Effective Resource Recovery

There are steps companies can take to ensure that their resource recovery efforts lead to the maximum possible return on surplus facilities and equipment.

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

Guidelines For Choosing The Right mAb Cell Line - Part 1

mAb success hinges on choosing the right cell line. Learn how making an informed decision helps to lay the foundation for a successful mAb development project, unlocking its full potential.

OUTSOURCING SOLUTIONS

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services - FUJIFILM Diosynth Biotechnologies

Codex HiCap RNA Polymerase - Aldevron

VintaBio Capacity Update July 2024: Cell & Gene Therapy - VintaBio

GS Effex Cell Line For Enhanced Antibody Effector Function - Lonza

Manufacturing Life-Saving Gene Therapies - Andelyn Biosciences

CDO Services: Agile. Flexible. Focused On You. - Samsung Biologics

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