06.03.25 -- Is Early Automation The Key To Scalable Cell Therapy Manufacturing?

20-minute capacity and capabilities quick-looks, 20+ brand new CDMO presenters to evaluate for best-fit this quarter – and a (virtual) commitment of less than 20 percent of your day? We’re confident you don’t need 20/20 vision to see the value in this! Join us for Outsourced Pharma's July Partner Week – including sessions in Cell & Gene Therapy, Analytical Services, and Fill/Finish among others. Registration, on-demand access, and interactive Q&A are free.

mRNA therapy and vaccine manufacturing can become complex and challenging when working with multiple CMOs. Partnering with an end-to-end CMO is key to overcoming manufacturing challenges.

The path to regulatory approval for LNPs demands careful consideration. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

The Regional Site Manager (RSM) monitoring model eliminates numerous clinical trial risks by leveraging efficient, start-to-finish site management by a single, expert point of contact.

Tony Sampognaro of Stoke Therapeutics, says, “We're having to rearrange and bolster the constellation of CDMOs we're working with." The nice thing is, Stoke has a comprehensive extended enterprise model. Nonetheless, an all-outsourced model “can add hidden complexity." Here's how to manage that.

By implementing an efficient characterization strategy, researchers can enhance the consistency of allogeneic cell therapy starting material, ultimately leading to improved clinical outcomes.

By refining variables such as starting DNA, reagents, cell density, and media composition, organizations can improve rAAV process efficiency and scalability.

Therapeutic developers can set themselves up for long-term success and ensure supply chain sustainability by investing in a high-quality master cell bank (MCB).

Finding partners with the necessary skills to optimize AAV processes is crucial for minimizing risk. Explore key considerations for advancing your therapy from concept to commercialization.

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

Yield and quality metrics vary significantly between AAV capsids, emphasizing the need for a modular manufacturing platform to address their unique requirements.

Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.

Consider how the following strategies can be used to optimize AAV manufacturing by reducing risk and balancing productivity, quality, and cost to meet the growing demands of gene therapy.

Extracellular vesicles hold immense potential for treating diseases, owing to their natural biocompatibility and ability to carry a diverse arsenal of therapeutic molecules.

Enhance RNA manufacturing with HiCap T7 RNA Polymerase, which minimizes dsRNA, boosts expression, and reduces capping costs for superior therapeutic development.

Learn how pharmaceutical and biotech companies can leverage cutting-edge technology to bring gene therapies to market, making treatments more readily available to patients worldwide.

Commercial biomanufacturing isn't static—it's an evolving process. This webinar shares real-world case studies from Lonza’s microbial manufacturing facility, highlighting how continuous improvement is achieved through data-driven yield optimization, process refinement, and deviation analysis. Attendees will learn how to maintain agility, apply Six Sigma tools, and build resilience into operations to enhance efficiency, quality, and performance. Click here to learn more.

This innovative approach holds promise for reducing the need for extensive clinical drug-drug interaction studies, potentially streamlining the drug development process.

Accelerate your gene therapy pipeline with our cost-effective, high-quality lentiviral vectors, optimized for clinical and commercial success.

Discover more about optimized storage, packing, labeling, and global distribution, seamlessly integrated for your supply chain. Simplify complexity and enhance the reliability of your supply chain.

Our platform offers clients a personalized, responsive, and expert-driven approach to process development and manufacturing from early clinical to pivotal supply and commercial launch.

Partner with us and harness our ability to provide high-quality constructs through in-house research and analysis capabilities that enable accelerated timelines for delivery.

Join Outsourced Pharma Live on June 11th at 2pm ET for a virtual panel discussion on the specific challenges of biologics development that must drive CDMOs to embrace more flexible approaches. Registration is free thanks to the support of Curia.