04.23.24 -- Outsourcing Nirvana At Eli Lilly

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!

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.

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

Explore a groundbreaking method to significantly enhance LV vector yield using engineered HEK293T cells. This approach paves the way for more efficient and large-scale production of LV vectors.

By investing in the establishment and maintenance of a high-quality master cell bank (MCB), therapeutic developers can set themselves up for long-term success and ensure supply chain sustainability.

Examine the post-thaw segment QC results for 2,249 consecutive segments cut at our institution, in order to create a benchmark of what is to be expected when interpreting segment testing.

Implementing NGS technology for adventitious virus testing in viral vector vaccine development and manufacturing is crucial for ensuring safety. Gain insights for an optimized sequencing method.

To ensure that your adeno-associated virus (AAV) therapy reaches patients as soon as possible, begin your relationship with an experienced AAV manufacturer early in the development journey.

Manufacturing RNA-containing LNPs demands specialized expertise  Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.

Review how to develop and use QC assays that can facilitate both product and process understanding and control.

Accessibility and availability of viral clearance services are critical when it comes to on-time filing with regulators. Explore a solution that supports your clearance needs.

Our gene therapy viral vector process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market through development of robust and reproducible cGMP practices.

We own and operate facilities that are designed exclusively for cell and gene therapy. All sites are fully equipped with standard equipment to manufacture autologous and allogeneic therapies using both open and closed processes.