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Nitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
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Lab Automation
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Product hub: Rapid mold detection in as little as one day
Quick to spread and difficult to detect, molds can compromise a facility in the time it takes to confirm their presence. The RMBNucleusTM Mold Alarm signals at the first sign of mold detection.
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Video: Ami Polymer: Setting new bioprocessing standard
Our dedication to quality and prompt service has earned us several awards. You can trust us for top-notch service and reliability.
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Application note: Highly efficient method development for analysis of oligonucleotides
Thorough quality control of nucleic acid drugs is important to ensure their safety and efficacy. In this application, an automated computer-aided workflow was used for highly efficient method development.
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Whitepaper: Changing regulatory environment for nitrosamine impurities
This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.
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Technical bulletin: Streamline your drug development pathway from preclinic to FIH/POC
No matter the industry, collaborations between multiple parties throughout a project pipeline can prove challenging.
webinar
How to implement single temperature incubation in your environmental monitoring routine
11 October 2023 | By bioMérieux
Watch this webinar to hear Laurent Leblanc explore the challenges and benefits of implementing the “one media / one temperature” approach for routine environmental monitoring.
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ebook: Accelerate the development of your biologics
Altasciences’ Proactive Drug Development can accelerate the development of biologics by up to 40%, from lead identification to clinical POC.
webinar
RMMs and endotoxin testing: efficiency gains and regulatory perspectives
13 September 2023 | By Veolia Water Technologies & Solutions, Sievers Instruments
Learn how Rapid Microbiological Methods can provide results in less than 45 minutes and endotoxin assays can be set up in less than 10 minutes to improve contamination control and reduce risk.
news
Pioneering PAT to improve gene therapy AAV manufacture
The CGT Catapult and two other collaborators have agreed to work together and use advanced process analytical technologies (PAT) to improve the process and efficiency of gene therapy AAV manufacturing.
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Technical document: Introducing: Ami Polymer’s Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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Leveraging PAT for environmental monitoring in light of Annex 1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
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Report: Accelerate the RMM validation process
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
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Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
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Whitepaper: Navigating nitrosamine impurity testing
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
