07.30.24 -- DMFs And CDMOs: Surprises At The Regulatory Intersection

Not really into choosing extended time away and exhibit halls over the simple pleasures of summertime? No reason to put your CDMO search on hold – Outsourced Pharma Capacity Update’s PARTNER WEEK is now available on-demand. Take the travel and headache out of your plans and tune in right from your computer. Assess potential fit for your next drug development project in convenient 20-minute segments – all grouped by molecule type. Detailed presentations include current available capacity across featured capabilities. View each session on-demand here.

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Benjamin Stevens, Director CMC Policy and Advocacy at GSK provides some initial thoughts on the regulatory aspects related to moving programs to and through the clinic as quickly as possible.

Reap the benefits of natural history studies, such as the collection of contextual data, dry runs of expected clinical study visits, test deployments, and test endpoint sensitivity.

Allogeneic therapies are gaining popularity due to diversity, scalability, and affordability. A partner with innovative solutions can help streamline the path to commercialization.

By utilizing an engineered co-transcriptional capping RNA Polymerase, researchers can reduce the production of double-stranded RNA byproducts and enhance the functionality of mRNA therapeutics.

Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.

Review how you can significantly increase AAV productivity and packaging efficiency for various AAV serotypes and client-specific Genes of Interest (GOIs) at the upstream production stage through plasmid engineering approaches.

Mathias Kahl, Director of Process Development, shares insights on overcoming challenges in AAV and LV viral vector manufacturing.

See how VirusExpress' technology was optimized to provide industry-leading lentiviral titer and a streamlined approach to accelerate development timelines and de-risk manufacturing.

Learn more about the strategies that helped accelerate the development timeline and build a process to isolate, engineer, and expand mature, thymic Tregs.

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? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

Review an update on our 400,000+ square foot campus in Philadelphia, Pennsylvania and the infrastructure dedicated to Cell & Gene Therapy development, testing and manufacturing.

BioCentriq's MS&T team serves as a hands-on liaison between our partners and our own process development and manufacturing teams, working to consistently improve how therapies are advanced from bench to bedside.