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In this Q&A, Natalie Saunders, Interim Head of Quality Control at CGT Catapult, delves into the advancements and challenges in microbiological QC for cell and gene therapies. She discusses rapid sterility testing methods, regulatory frameworks, and the impact of automation and digitalisation on quality control.
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
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.
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
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.
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…
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
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.
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.
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,…
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…
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…
