10.28.24 -- You Still Can't Find Your Providential CDMO?

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.

In this episode, we welcome Verve Therapeutics' Praveen Prasanna, Ph.D., GenSight Biologics' Scott Jeffers, and University of Minnesota's Vaibhav Patel to explore 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.

Pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and detracts from your strengths in drug development.

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.

As innovative cancer therapeutics continue to enter the clinical trial pipeline, some developers are shifting their focus toward developing drugs that are safe and efficacious with minimal toxicity.

Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

Pre-clinical models are pivotal in unraveling disease mechanisms and developing novel interventions. However, bridging the gap between pre-clinical findings and clinical applications remains a challenge.

Utilizing expert analytical testing services can unlock the potential of biosimilars and bring cost-effective treatments to market faster.

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

Discover how CASPON Technology can revolutionize your recombinant protein manufacturing processes and enhance efficiency.

Simtra currently has open capacity for liquid vial projects at both manufacturing sites and can support rapid tech transfer depending on the complexity of the project and the availability of materials.

Director of Technical Transfer JoAnne Jacobs shares the origins of our team and our mission: to provide best-in-class CDMO services to meet the growing demand for injectable drug product supply.