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Application note: Taxonomic traceability for bacterial and fungal entries in Accugenix® reference databases
When you are reviewing bacterial and fungal isolates, do you appreciate that the names given to these organisms are regulated?
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Biopharmaceuticals
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Application note: BIOBALL® Burkholderia cepacia complex strains performance testing for USP <60> growth promotion requirements
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
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Product hub: 3P® connect EM-BODY connectivity
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
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Enhancing efficiency and economics in process development and biotherapeutics
Discover how GSK and Aragen Biosciences streamlined their processes using various techniques that produced multiple benefits, including increased throughput, improved quality control and reliable automation.
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Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, experts discuss how a future skills shortage may impact the biopharma industry and the key considerations when validating assays and analytical methods for ATMPs.
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Video: Horseshoe crab sustainability project: 1 million and counting!
Associates of Cape Cod, Inc.'s one of a kind sustainability project meets a milestone of one million juvenile horseshoe crabs released in Massachusetts!
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Whitepaper: CMC regulatory landscape, cell and gene therapy products
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
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Catalogue: ACC products & services
Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for nearly 50 years.
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Technical paper: Low risk frozen distribution of SU bags for bioprocessing
This paper discusses the results of a study that help to mitigate the risks during frozen shipping and ensure consistent product quality in cold chain.
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Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
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Whitepaper: The new age digital contract research organisations
The ideal CRO digital platform offers an opportunity to un-burden bureaucracy and drive data capture and integrity straight into the digital eco-system allowing earlier intervention.
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Challenges and innovations shaping the bioprocessing industry
In this article, Robert Newman and Tom Fletcher explore how the bioprocessing industry has changed in the last 50 years and where the future may lead…
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Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
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Supplement: ACC endotoxin
The launch of ACC's PyroSmart NextGen™ recombinant Cascade Reagent (rCR) marks the introduction of a new sustainable recombinant LAL reagent technology for bacterial endotoxin testing (BET).
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European Pharmaceutical Review Issue 6 2021
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
