The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.
When your warehouse stores temperature sensitive pharmaceuticals and life science products, a top of the line HVAC system with carefully placed thermostats is not enough to ensure product quality and consumer safety. Why? It is the nature of warehouse facilities, no matter the size, to experience temperature gradients.
While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime. Acronyms are independent monitoring system (IMS) or environmental monitoring system (EMS). Software presents that data as information; real-time alarms notify facility operators of alert limits to enable an immediate response to an unwanted event or excursion. Reports and trend graphs can be produced.
Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier
From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.
Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.
Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established.
The biopharmaceutical market is undergoing tremendous transformation. Speed to develop and manufacture product has become a critical driver with increased competition and the pressure to be first to market. New process technologies, advances in cell line development and more targeted and complex therapeutic classes have created a challenging biopharmaceutical manufacturing environment with new capacity requirements.
Join this webinar to learn more about this unique approach and how you can benefit from it in different situations. Our Chief Scientific Officer will share the theory and background behind the solution and demonstrate how Unscrambler® X Batch Modeling from CAMO can improve the way we manage time-dependent processes and as an effect, get better quality control, detect events early and overall help improve quality of products and processes.
