ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

• Key Considerations For Labeling Your Cell Or Gene Therapy

  As sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• Inside A Gene Therapy Facility, Commercialization & Industrialization Project

  An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases. 

• Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch

  Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.

• IMP Labeling: EU CTR Transition Considerations

  Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

• Building A Global Cell And Gene Supply Chain Serving Personalized Medicine

  Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.

• Faster From Formulation To Fill/Finish

  Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

• Speed To Market – API Large-Scale Commercial Manufacturing

  Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

• Effective Use Of IRT In Decentralized And Hybrid Clinical Trials

  Uncover the ways interactive response technologies are helping trial sponsors manage the distribution of medications, forecast trial supply, and integrate workflows with other technology platforms.