Product Development

Technical
What if the reliability of a system could be improved by accessing the standard data provided with modern process instrumentation? These data, accessed from existing instrumentation, can be used to analyze the fitness of processes, equipment, and instruments; better understand processes; support...
iSpeak Blog
What Does Contract Manufacturing Look Like In Pharma? Many factory productions can be outsourced to contract manufacturers (CMs) in order for businesses to continue providing quality products to their customers in a cost-effective way, and so they can focus on other aspects of their business,...
Features
Digital transformation and digitalization are on the agenda for all organizations in the biopharmaceutical industry. But what are the main enablers of intelligent manufacturing? We hypothesize that data science–derived manufacturing process and product understanding is the main driver of...
Features
Drug developers know that the odds of anyone compound demonstrating safety and efficacy for a disease and its affected populations are low. How can drug developers improve these odds and increase the efficiency and effectiveness of drug development? One useful tool is model-informed drug...
iSpeak Blog
Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain...
Technical
Regulatory authorities have approved the use of recombinant monoclonal antibodies (mAbs) to treat infectious diseasesSparrow, E., M. Friede, M. Sheikh, and S. Torvaldsen. “Therapeutic Antibodies for Infectious Diseases.” Bulletin of the World Health Organization 95, no. 3 (2017):235–237....
Features
Medical treatments and pharmaceuticals are indispensable in improving quality of life. In recent years, however, pharmaceutical compounds have become a significant group of environmental pollutants, shown to pose risks to human health and have adverse environmental effects.
Video
One Size Does Not Fit All: Strategies for Bringing Advanced Therapy Medicinal Products to Market The number of advanced therapy medicinal products (ATMP) on the global market is fewer than expected despite the large...