For medical devices, the use of human factors and usability engineering (e.g., applying the knowledge of human behavior, abilities, and limitations to the design of a medical device) plays a key role.
Which methods are most prominent in the pharmaceutical containment industry today and what key challenges are pharmaceutical businesses facing.
The global HPAPI market was valued at US$14.4 billion in 2016 and is expected to grow at a CAGR of 10.3 per cent, reaching US$34.8 billion by 2025.
New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing.
Sustainability means a balancing act and the ability to maintain a certain regulatory standard and the approach of in-built sustainability is essential when designing biopharmaceutical facilities.
This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.
Key considerations linked to containment performance testing, data collection methods and the interpretation of results.
This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
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