Get Ready, Pharma: Drug Supply Chain Security Act (DSCSA) Enforcement Is At Hand
More than 10 years ago, Congress passed a law designed to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Up until now, it has never been fully...
The cell and gene therapy revolution: Milestones, mindsets and the path forward
The evolving landscape of cell and gene therapies (C>s) holds transformative potential for the future of medicine. From early experimental trials to groundbreaking FDA approvals, the journey of C>s has been marked by rapid...
How FastIns Modular Cleanroom Improve Pharmaceuticals in AI Era
When it comes to the manufacturing of drugs, particularly culture of cells, a high-level of clean and sterile environment is required with temperature, humidity and differential pressure controlled to certain ranges. Typically, traditional clean...
Accelerating Towards Net Zero: Transforming The Pharmaceutical Supply Chain
The pharmaceutical industry is making remarkable progress in its quest for decarbonisation, with emissions already on a significant decline. Yet, the journey to Net Zero remains fraught with challenges, particularly in curbing Scope 3...
Preparing for the revisions to the EU’s pharmaceutical legislation – what we know now
The European Parliament recently introduced compromise amendments to the revised EU pharmaceutical legislation introduced in April 2023, and they attempt to address some of the concerns of the pharmaceutical industry and, at the same...
How Automation Improves ADC Development
For many years, mass production has been the most prominent way to provide pharmaceuticals for all kinds of medical conditions. Large manufacturing sites have been established to produce vast amounts of uniform medications, with...
Pharma and Biotech’s Green Revolution
At its core the production of life-saving medicines for patients all over the world is meaningful and sustainable. Yet, there is still a considerable environmental impact in terms of waste disposal, CO2 emissions, and...
Harmonizing Biologics: Navigating Immunogenicity in Drug Development
The introduction of gene therapies and therapeutic proteins has marked a revolutionary step in combating disease. However, these advanced treatments must navigate the challenging landscape of immunogenicity, where the body's defense system reacts to...
The 6-step clinical manufacturing checklist for injectable drug products
For emerging drug developers, the shift from lab to clinic is a transition that can lay the groundwork for success at many future milestones – from key early regulatory submissions to future partnerships and...
Pharma Innovation a World Pharma Today Round Table
It becomes imperative that innovations keep upgrading in the pharmaceutical sector, be it clinical trials or the supply chain. As drug development and storage become more intense, there is indeed a significant need to...