news
Pharmaceutical sterility testing market to grow from $2.07b in 2027
Research suggests that the global sterility testing market will see a nearly $200 billion increase in spending on new products in the next five years.
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rapid sterility testing
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Pharmaceutical microbiology: key developments 2022
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
webinar
Implementing a real-time PCR-based method for sterility release testing of ATMPs
23 December 2022 | By Sartorius
Dr Alexandra Mueller-Scholz, Sartorius, and Yasmin Heynen, Molecular Development at Labor LS, discuss rapid sterility testing for ATMPs using a real-time PCR-based method.
whitepaper
Product hub: How can CGT manufacturers ensure product safety with Microbial Solutions QC test methods?
Innovation forms the basis of every emerging technology. That is certainly the case with cell and gene therapies (CGTs), and the search for efficient quality control (QC) test methods continues to grow in this pharmaceutical sector. One of the most important factors to consider while deciding on a QC method…
news
Raman spectroscopy – a promising alternative approach for sterility testing
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
news
Pharmaceutical sterility testing market to value over $1000 million by 2027
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
article
Expert view: Sterility testing of challenging samples
While membrane filtration is often straightforward, some sample types can be challenging. These include difficult-to-filter viscous oils, water-in-oil emulsions and fatty base ointments as well as samples containing substances that inhibit microbial growth.
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Nelson Labs: supporting internal quality processes
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
article
Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations
10 July 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the third paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Rapid sterility testing is one of a number of applications that novel microbiological technologies afford the pharmaceutical industry. RMM technologies have already been validated and implemented for…
article
Article 5: The implementation of rapid microbiological methods
1 November 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives…
