INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Illuminating The Pathway To Efficient Drug Development For Small Biotechs

  To guide a biotech through successful drug development, there are three key areas a CDMO should focus on: equipment and instrumentation, organization and personnel, and systems and processes.

• Communication Is Key In Getting The Most Out Of CDMO Partners

  In this segment of the Outsourced Pharma Live virtual event A New Age For Small Molecule Development, Sesha Neervannan, PhD, COO, Tarsus Pharmaceuticals and Bethany Dudek, Chief Technology Officer, Arcutis, discuss the importance of internal management and a communication plan with CDMO partners. Establishing ground rules with a new partner before the work begins will help sponsor companies avoid delays and other issues. A CDMO partnership must be managed actively, not passively.   

• Redundancy As Fail-Safe: Is It Feasible To Hire Backup CDMO Support?

  In this segment of the Outsourced Pharma Live virtual event A New Age For Small Molecule Development, Bethany Dudek, Chief Technology Officer, Arcutis, Sesha Neervannan, PhD, COO, Tarsus Pharmaceuticals, and Conrad Wüllerm MSc, Director of Strategy & Operations, ARTBIO, offer thoughts about when it makes sense to hire multiple CDMO providers to prevent disruptions due to shortages or other unforeseen events. For commercial products, having more than one source is almost always necessary, but companies in the development stages need to weigh the risks of disruption against the costs of partnering with multiple CDMOs or suppliers.

• Pros And Cons Of Partnering With CDMOs Inside And Outside the U.S.

  In this segment of the Outsourced Pharma Live virtual event A New Age For Small Molecule Development, Conrad Wüllerm MSc, Director of Strategy & Operations, ARTBIO, Sesha Neervannan, PhD, COO, Tarsus Pharmaceuticals, and Bethany Dudek, Chief Technology Officer, Arcutis, discuss the benefits and challenges of partnering with CDMOs in the US and globally, and offer advice on how to mitigate supply chain risks.

• Finding CDMO Capacity In Radiopharmaceutical Drug Development

  In this segment of the Outsourced Pharma Live virtual event A New Age For Small Molecule Development, Conrad Wüllerm MSc, Director of Strategy & Operations, ARTBIO discusses challenges unique to the development and manufacturing of radiopharmaceuticals, a growing area of interest and activity for large and small biopharmaceutical companies. Timelines are particularly important for radiopharmaceutical manufacturing, due to short product half-lives, explains Wüllerm.

• Red Flags And Dealbreakers in CDMO Selection

  In this segment of the Outsourced Pharma Live virtual event A New Age For Small Molecule Development, Bethany Dudek, Chief Technology Officer, Arcutis, and Sesha Neervannan, PhD, COO, Tarsus Pharmaceuticals discuss the importance of an established track record regarding quality and compliance. Neervannan also talks about other ways to evaluate a potential CDMO’s compatibility as a partner, such as response time to questions during the vetting phase prior to selection.

• Know Your Own Strengths And Weaknesses Before Selecting A CDMO

  In this segment of the Outsourced Pharma Live virtual event A New Age For Small Molecule Development, Sesha Neervannan, PhD, COO, Tarsus Pharmaceuticals and Bethany Dudek, Chief Technology Officer, Arcutis, share thoughts about selecting small, boutique service providers versus large, full service CDMOs, as well as key attributes they look for in a potential partner. Dudek also talks about why it’s important to know your own internal strengths and weaknesses before selecting a CDMO.

• Choosing The Ideal CDMO Partner For Cell Line Development

  Explore key factors in selecting the right CDMO partner for cell line development, including expertise in host cell background, preparation for complex protein production, and an emphasis on optimizing and de-risking manufacturing.

• Enhancing AAV Purification: Strategies For Improved Recovery And Quality For Downstream

  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.

• Scalability Of A Flexible, High-Producing Triple-Transfection rAAV Platform

  Explore a demonstration of a scalable, high-yield triple-transfection rAAV platform's flexibility and efficiency, enabling gene therapy production with robust performance metrics and streamlined processes.