Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies.
By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.
This application note demonstrates the binding capacity of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies.
This summary just scratches the surface of the complexity involved in extractables and leachables studies, but it shows the value of aligning different recommendations to form a coherent strategy.
Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.
Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.
Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.
Accurate and timely delivery of clinical trial supplies helps to ensure that a study’s timeline stays on track. Sponsors often focus on upfront planning to ensure sites are prepared to reach clinical milestones but ignore the logistical challenges of reconciling and destroying clinical returns. This article breaks down how to effectively manage the clinical supply returns process and how to design a more holistic strategy.
The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.
Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.
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