09.24.24 -- In Defense Of The Full-Time Equivalent (FTE)

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.

This CMC (chemistry, manufacturing and control) professional spends a good deal of time thinking about and interacting with his CDMOs. Through his experience, he knows that ineluctably some form of challenge will arise. Just another day at the office?

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships?

Learn how the streamlined processes and reduced complexity enabled by a platform approach can lead to scalable manufacturing, rapid delivery, and expanded patient access.

This study evaluates filter trains from four vendors, aiming to enhance titer recovery, HCP removal, DNA breakthrough, turbidity reduction, and throughput in gene therapy manufacturing.

Review a well-established platform process for lentiviral vector (LV) production based on transient transfection of serum-free cells grown in suspension.

Explore the pivotal role of flow cytometry in CAR-T drug development, from monitoring CAR-T cells to assessing efficacy, as well as how this technology drives precision in clinical trials.

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

As developers begin their AAV therapy research, opting to conduct early phase studies with an experienced CDMO can help mitigate funding challenges and procure material for clinical data generation.

By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.

For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk.

A helper virus-free stable producer cell line is derived from proprietary high-producer HEK293 cells and is cultivated in a chemically defined, serum-free, ADCF medium in suspension.

A partner that leverages reliable collection, processing, manufacturing, and cryopreservation is key for producing fully characterized starting material that meets the highest standards.

Experts discuss how cell & gene therapies are changing the healthcare landscape and what needs to be done to bring these advanced therapies to patients.