05.07.24 -- A Good Feeling ($$) About Contract Manufacturing

Outsourced Pharma Capacity Update is expanding! Leading CDMOs share their current available capacity - and associated capabilities, facility locations, and timelines - to help you identify options for your formulation development and manufacturing needs. Secure your spot today for our featured Cell and Gene Therapy session happening May 23rd!

Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. Review how a platform approach to fast-track AAVs can enhance quality and efficiency.

Create a simple, modular path to cGMP manufacturing that minimizes risk. Explore a strategic approach for early-stage development and how it can propel therapies to the clinic and the market.

Experts discuss automated processes, “platformization,” moving early-stage companies into a commercialization structure, and how the industry can support the academics developing these processes.

Unearth why defining meaningful biomarker endpoints has become more nuanced than just figuring out whether the protein of interest is being proliferated or silenced.

Learn the principles of commercialization readiness and guidance to address them in process development as well as the best time to implement automation and minimize commercialization risks.

Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.

Examine the similarities and differences between how the FDA and the European Medicines Agency approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

To support fast-track clinical programs, CMC professionals in early-stage biotechs find themselves behind the eight ball. Start-ups overestimate their understanding of the scope, complexity, and impact of CMC. They then rely on CDMOs to assist with arbitrarily decided clinical start dates. Outsourced Pharma Live is here to offer remedies for all this pushing a program into and through the clinic, and for effective utilization of CMC operations. Register today!

The OBiO Intelli-M manufacturing site can accommodate comprehensive and diversified solutions for large-scale production, with eight virus production lines with the production capacity from 20 L to 2000 L.

Our platform technology approach combined with our expertise to design, manufacture, and develop advanced next-generation therapies enables us and our partners to bring novel treatments to patients.

Explore a simplified solution for cell and gene therapy development and manufacturing that begins and ends with the patient.