10.08.24 -- Warning To US-Based CDMOs: Don't Get Complacent

This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

BioPlan Associates, Inc. allows Chief Editor Louis Garguilo to share key insights from their annual survey. This year, he notes that “focus on supply chain security is already abating,” and there's growing competition for talent between sponsors and suppliers.

Antiksha Joshi, Urmi Quality Management Consulting, and Reza Oliyai, Oliyai Consulting, stress the need to establish a coherent, internal outsourcing strategy at biotechs before looking to form strategic partnerships at CDMOs, and provide some examples.

Explore some questions and considerations to help you decide on how to manufacture, either by building capacity and capabilities or partnering with any number of different kinds of CDMOs.

Uncover how, much like a fingerprint, each B-cell possesses a unique identity, and how deciphering this code can unlock a wealth of possibilities in antibody development, immunotherapy, and beyond.

A recent webinar discussing the use of SV-AUC to characterize and quantify AAV species also featured a Q&A with presenter N. Karl Maluf, Ph.D.

Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

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.

Review key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.

Experts emphasize the significance of the cell line in viral vector manufacturing — a multi-step process that has traditionally been time-consuming and labor-intensive — in this presentation.

Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.

This stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.

Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

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

Our viral vaccine lot release package includes a range of assays to ensure the quality and safety of your vaccine, such as titer determination, potency assay, gene sequencing, and adventitious agents.

Work with us from start to finish of your product or partner with us at any stage of your project — preclinical through commercial scale.