Newsletter | January 30, 2025

01.30.25 -- How Does A Successful Client-CDMO Partnership Meet Challenges?

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Though analytics are ubiquitous across biologic development and manufacturing, it is vital to identify a CDMO with the technology necessary to prepare your drug for clinical trials and eventual commercialization. Unsure where to begin? Start by assessing how a CDMO approaches analytics throughout each phase of development.

FOCUS ON OUTSOURCING

How Does A Successful Client-CDMO Partnership Meet Challenges?

Life Biosciences' Jerry McLaughlin and Forge Biologics' John Maslowski explain the importance of transparency and collaboration when encountering manufacturing speed bumps.

How MSAT Drives Efficient Tech Transfer

A CDMO’s manufacturing science and technology (MSAT) plays a critical role in optimizing a biomanufacturing process to meet the needs of the modern healthcare landscape.

Nanoparticle Engineering Addresses Poor Aqueous Solubility Challenges

As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

Building The Next Therapeutic Modality With End-To-End Product Support

Extracellular vesicles hold immense potential for treating diseases, owing to their natural biocompatibility and ability to carry a diverse arsenal of therapeutic molecules.

How Can You Ensure Successful Late-Phase Development And Launch?

It is important to consider several factors in the overall development approach during the early phases in order to de-risk the late-phase development of your biologic drug product.

Realizing The Potential Of Intensified Scalable Adherent Cell Culture

Realize the importance of alternative approaches to viral vector production and the benefits of intensified adherent cell culture for improving efficiency, reducing costs, and accelerating development.

Characterizing The Effect Or Functions Of Therapeutic Antibodies

Understanding the Fc region of your antibody is crucial for assessing the impact on immunology, safety, and efficacy. Explore how to determine the most efficient way to test functionality.

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.

OUTSOURCING SOLUTIONS

Biologics Contract Development & Manufacturing Services - EirGenix Inc.

Container Closure Integrity Testing - Lonza

Adenovirus Vector Lot Release Package - WuXi Advanced Therapies

Capacity Update October 2024: Large Molecule Drug Substance - Curia

Capacity Update July 2024: Large Molecule Development - Aton Biotech

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