All AI, analytics and decision support articles – Page 6
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Whitepaper
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.
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Webinar
RMMs and endotoxin testing: efficiency gains and regulatory perspectives
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.
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NewsPioneering 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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Whitepaper
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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ArticleLeveraging 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 ...
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WhitepaperReport: 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
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
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.
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Whitepaperebook: Benefits of liquid-filled capsules for pharmaceutical development
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
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Webinar
Advantages of automated microbial colony counting
Watch this webinar with independent microbiology expert Dr Tim Sandle to explore the different technologies, regulatory concerns and validation requirements for automated colony counting methods.
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Whitepaperebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
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NewsAutonomous PAT with digital twin integration reported
Autonomous biologics manufacturing with process analytical technology (PAT) “opens up a new frontier for aqueous two-phase extraction (ATPE)" in this sector, according to research.
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Whitepaperebook: Accelerate the development of your small molecule
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
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Video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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NewsGlobal PAT market expected to exceed $10b in 2032
Digitalisation is a driving factor for the global process analytical technology (PAT) market, according to a report.
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NewsFirst AI-generated small molecule drug enters Phase II trial
Insilico Medicine’s novel AI-generated small molecule inhibitor drug represents a new milestone in pharmaceutical drug development.
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VideoVideo: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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Whitepaper
Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
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NewsHow can AI be best harnessed for pharmacovigilance data?
A GSK-funded paper on pharmacovigilance stated that the pharma industry needs to harness the properties of data to allow optimal use of AI, otherwise "we will fail to do all we can for patient safety".
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Whitepaper
Scientific journal: Reduce CNS drug development timelines by up to 40%
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.