INSIGHTS ON DRUG DEVELOPMENT

• Considerations For Your First Clinical Trial

  For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming. Tt is important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven ‘clinical trial supply best practices’ to help ensure a successful trial.

• Phase-Appropriate Drug Development – Validation Process

  The drug development process is among the most complex, costly, and regulated of human pursuits and the statistical chances of success are horribly low. However when we couple new trends in patient disease knowledge with a disciplined phase-appropriate process for drug development, a more cost effective, success-oriented model emerges.  Let’s consider phase-appropriate development by applying it to process validation.

• Meeting The Process Development Challenges Of A Diverse Biologic Pipeline

  The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.  

• Improving End Results In Phase II Through Media Optimization

  Challenges in drug development today call for manufacturers to identify not only what new capabilities and resources they need to get ahead but also how to optimize current processes to fuel growth. 

• Addressing The Complexity Of Process Validation For Cell And Gene Therapy Products

  In the cell and gene therapy space, the FDA and the EMA have published several documents that offer guidance about early stage filings; however, these have provided limited reference to process validation and product commercialization. The expectation ― just as it is with biologics ― is that the process is the product. However, cell and gene therapy products have unique features that must be considered during process validation.

• Platform Cell and Gene Therapy Media Development

  As the industry moves from small molecules and natural products into biologics, engineered cells and viral vectors, and ultimately to the future where we're manufacturing restorative or regenerative therapies in their entirety, we have a tradeoff between the simplicity of the process and how cost effective it is. Here we describe our process, highlighting a case study to remove serum from the expansion step of an autologous cell therapy. The challenge is to do so in a cost-effective manner without affecting cell performance.

• Practical Tips To Develop A Lentivirus Packaging Cell Line

  CAR T therapies are expensive, and  lentiviral vectors (LV) production represents a large portion of these costs. High manufacturing costs for LV are driven by low efficiencies from limited scalability in adherent cell culture, as well as requirements for large manufacturing spaces and several manual manipulations that increase labor costs. Following are practical tips and a case study to develop a lentivirus packaging cell line.

• Challenges And Practical Solutions For Switching To Prefilled Syringes For Injectables

  To achieve the benefits of moving a final product presentation from vials to prefilled syringes, it is important to understand the challenges during this solution as well as practical solutions.