10.22.24 -- BIOSECURE Act Starts Dismantling WuXi

Arezou Mehrabi has a spellbinding supply-chain case study. It transpired, of all places, in Iran. It includes major challenges in outsourcing manufacturing to a partner CDMO for a top-ten pharma (Sanofi, to be exact). Our protagonist is a woman who took leadership within a male-dominated workplace, country, and entire region. 

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.

Computerized Maintenance Management Systems (CMMS); Integrated Facilities Management (IFM); Mechanical / Electrical Systems (M&E); and pest control (!) ... who handles maintenance at your CDMO? Here's what you should know from someone who has been doing it for decades.

At various points during our recent Outsourced Pharma Live, our experienced outsourcers turned their attention to “turning on” the value from PMs at your CDMO.

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.

Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product.

Stringent QC release testing throughout biologic production, as mandated by health authorities, ensures product safety and quality through evaluations of identity, purity, potency, and critical quality attributes.

Review considerations for a successful development and manufacturing process and learn how finding an experienced partner can help you overcome hurdles on the path to IND.

Speeding up the tech transfer process is a key variable in shortening development timelines and controlling costs, maximizing a molecule's potential for late-stage success.

This panel session features a decade-long story of partnership in bringing two life-changing gene therapies to market successfully in 2022.

Through detailed case studies and technical explanations, learn how TCR sequencing can improve patient stratification, treatment monitoring, and the development of novel therapeutics.

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

Achieving optimized, scalable suspension processes for adeno-associated virus (AAV)-based therapeutics comes with a number of technical and business challenges.

By focusing on precision and quality, we aim to ensure that every therapeutic product meets the highest safety benchmarks, ultimately contributing to more successful treatments for patients in need.

Examine the benefits of a new cryogenic storage tank and how this innovative technology will mitigate risk in the cell and gene therapy supply chain.

Consider how a new high-speed aseptic filling line can help bring your product to market with speed and efficiency while ensuring safety and high product quality.