12.01.23 -- DSCSA Delayed: Pros, Cons, & What To Do Now

This is the final installment in our series pursuing the practical use of artificial intelligence (AI) in the biopharma supply chain, guided by Professor Tinglong Dai of Johns Hopkins: a look at continuous processing and monitoring, and AI.

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.

Performing stability studies is a critical step in the drug development process. Explore the ways to ensure that your drug is safe and effective as it goes to market.

All drug R&D is expensive, but the cost and time lost from backtracking can impact preclinical costs and set your IND start back. Walk through some scenarios and learn about a unique team filling the gap.

Patients are preferring their medication in OSD forms, and as more complex products advance toward production, developers will turn to CDMOs for support in harnessing advanced dose form manufacturing techniques.

Oncology drug development has seen a significant shift in focus, as molecule chemistries and drug technologies have improved. Explore five areas for consideration and the potential emerging solutions.

A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase 2/3 trials.

Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.

Discover how the right people are distinguished as the most impactful variable of any outsourcing equation and contributing to the delivery of life-changing therapies.

Learn how a partner with process development and manufacturing experience and an extensive track record of delivering new or optimized routes can help guide your project toward commercialization.

Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.