Whitepapers

By integrating QbD into the development process, organizations can achieve robust manufacturing processes, regulatory compliance, and commercial success.

In vitro transcription (IVT) is often used to make mRNA, and in co-transcriptional capping an analog cap can be used to cap the mRNA. This paper reviews the recent history of capping analogs in addition to a state-of-the-art approach to improve protein expression.

Drug stability impacts efficacy and safety. Choosing the right packaging is crucial. This paper outlines key factors affecting stability and provides packaging guidelines.

Ecolab is looking to the future with new opportunities to partner with Pharma for critical solutions to support drug development and manufacturing.

This whitepaper provides an overview of developing a comprehensive contamination control strategy (CCS), taking into consideration the various aspects of pharmaceutical manu

Daniel Galbraith, Chief Scientific Officer (CSO) of Solvias provided a comprehensive picture to Pharmaceutical Technology of the current landscape of cell and gene therapy advancements. The discussion covers important regulatory guidance, technological landmarks, and how Solvias is impacting the current market.

Pharmaceutical companies rely on and trust BD to provide consistent testing outcomes for their critical tests, with the tools they need to effectively monitor and control their manufacturing environment. From environmental monitoring, sterility testing and media fill results, there is a life connected.

Developing successful oral solid dosage forms necessitates partnering with a CDMO equipped with distinctive technologies and expertise to enable support across solid-state characterization, formulation development and scale-up manufacturing processes.

As the number of highly potent oral solid dose (HPOSD) drugs in development and on the market increases, so are regulator’s expectations regarding their safe manufacture. In this white paper Pfizer CentreOne examines what developers and their manufacturing partners need to know about its unique regulatory challenges and how to navigate HPOSD’s complex manufacturing environment successfully.

Lipid-based formulations (LBFs) and softgels can offer numerous advantages in terms of clinical and commercial potential. Integrating formulation and manufacturing to enhance drug solubility and market speed can help unlock these benefits. Learn more about:

Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up-or scale-down-can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which results in low bioavailability. Lonza has over 20 years of experience in the scale-up and scale-down of spray drying processes. To learn more, read our executive summary.

The increasing number of breakthroughs in small molecule drug development are exciting, but corresponding workflows are complex and require much more tailored approaches to ensure successful upstream and downstream processing, drug approvals and commercialization.