Whitepapers

This case study explores the deployment of an innovative logistics solution designed to support the survival of premature infants through the rapid collection, retrieval and delivery of essential, temp-sensitive supplements to hospitals in Sydney, Australia. Storage specifications for the supplements was -20°C with instant availability required upon order. Retrieval was immediately followed by expedited delivery at -80°C with dry ice. Executed by Marken, this project required a comprehensive system enabling immediate access, and transportation of these critical supplements, ensuring they reach newborns in regional hospitals when every second counts.

Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.

Harmonizing technological innovation and a platform approach in biomanufacturing can reduce time and cost barriers to produce stable, high-expressing antibody-based therapeutics

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.