Whitepapers

Choosing the best location for packaging and distributing clinical supplies depends on various study factors and business needs. There’s no one-size-fits-all answer, but by evaluating key considerations, sponsors can determine whether the EU or non-EU countries like the UK best fit their clinical supply strategy.

China is a key player in global clinical trials, yet its intricate regulatory environment and logistical challenges demand meticulous supply chain management. Catalent provides tailored services such as Free Trade Zones, temperature-controlled shipping, and local comparator sourcing to support sponsors in executing trials effectively and in compliance with regulations.

The landscape of cell and gene therapy is rapidly evolving, with increasing approvals for diverse indications. Preserving the integrity and efficacy of cell and gene therapy products is critical. Vial adapters facilitate the transfer of drug product from a vial by securing an efficient connection between the vial and the administration device. Learn more about how sterility and accurate dosing are maintained while preserving stability.

The road to market access is long and complex. Choosing a CDMO with experienced staff can prove vital to success. In this executive summary, Praveenkumar Devakadaksham and Dr. Roché Marcel Walliser explain all the ways they help make the journey from pharmaceutical development to commercial distribution as smooth as possible. Learn more about:

Discover how our precision processes and dedicated personal support can expedite even the most complex drug programs.

Drug products in development require compatible packaging to meet milestones and gain approval. West supports pharmaceutical partners with a data-driven process to give you confidence with closure containment that meets requirements in the modern regulatory landscape.

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.

As described in the chapter subsection USP <1207.3> Package Seal Quality Test Methods, the measurement of residual seal force (RSF) indicates the quality of the vial package seal, giving insight into the quality of the sealing process. Correlating RSF to CCI data enables optimization and validation of the vial sealing process with parameters that give assurance of good CCI. This Case Study describes how science-based statistically valid RSF data was generated on the vial sealing process and combined with CCI data to ensure good CCI of sterile product needing deep cold storage

Download this Case Study to learn how a purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

This new case study demonstrates how a non-destructive container closure integrity test method can be developed for autoinjectors with an optically transparent window.

Created specifically for the pharma biotech industry by Veltek Associates, Core2Scan is the tracking, asset management, and process improvement solution that boosts bottom lines and so much more. Powered by RFID, Core2Scan keeps tabs on any onsite physical asset your organization wants to track. Better yet, its invaluable data can drive smarter processes and savings throughout your entire G-M-P facility.