Issue: Vol. 43

Safeguarding every R&D sample: how sustainable storage and smart scalability keep research viable

This article examines the critical importance of sustainable and scalable sample storage in safeguarding R&D samples for pharmaceutical, biotech, and CDMO organizations. It highlights how overlooked storage risks — from outdated infrastructure to regulatory gaps and transport failures — can compromise sample viability, delay research timelines, and drive up costs. The article aims to show that integrated sample stability and biorepository management should be proactive, requiring robust systems, smart cold chain logistics, disaster recovery planning, and clear data traceability. By reassessing internal capabilities and strategically outsourcing when appropriate, companies can protect their research investments and ensure continued innovation and compliance.

Read More »

Bridging the Gap: How Pre-Formulation and Strategies Enable Scalable PROTAC Development

Proteolysis-targeting chimeras (PROTACs) hold considerable potential for the treatment of diseases such as cancer. Following their first publication in 2001, their development has rapidly progressed, with some now reaching Phase III trials. However, developing PROTACs successfully requires a robust, multidisciplinary framework, especially during pre-formulation and analytical development.

This article examines the basic mechanisms and characteristics of PROTACs, highlighting the importance of early-phase formulation decisions during development. Additionally, solid form and solubility strategies for maximizing ease of formulation, including particle engineering and amorphous solid dispersions (ASDs), are also explored. Finally, the article highlights the vital role of contract development and manufacturing organizations (CDMOs) in leveraging handling capabilities and technical know-how to help innovators unlock the full potential of these novel molecules.

Read More »

Login