FEATURED EDITORIAL
ICH has revised Q9 Quality Risk Management, and it provides principles and tools for quality risk management that can be applied throughout the product life cycle of drug substances, drug products, and biological and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. Submit comments by July 15, 2022.
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FEATURED APPLICATION CONTENT
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Discover how a multi-capillary system can be used to accelerate development of sensitive, high-throughput analytical methods, while potentially decreasing time to market for biologics.
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We demonstrate the combination of routine characterization and elucidation of challenging residues in one single analysis, without the need for sample specific optimization.
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We demonstrate in-depth peptide mapping of new and complex molecules, as well as standard monoclonal antibodies (mAb), that can be achieved with this system in a fully automated fashion.
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Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
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Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
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This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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Here, electron activated dissociation (EAD) on the ZenoTOF 7600 system is used for the complete structural elucidation of glycerophospholipids, sphingolipids, and acylglycerols in a single experiment.
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Fragmentation is required to provide structural information about metabolites during drug discovery. Here, two orthogonal fragmentation techniques are compared to determine the in vitro metabolism of the drug darunavir.
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This application note studies the site-localization of malonylated peptides using the SCIEX ZenoTOF 7600 system.
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How a multi-capillary electrophoresis (CE) system is used to efficiently separate a wide range of RNA-based molecules by size and demonstrates the multiplex capability for RNA characterization.
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In this technical note, we demonstrate parallel, highly reproducible capillary isoelectric focusing analysis using a multi-capillary separation approach to accelerate analysis time.
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We highlight how a multi-parameter approach using CE-SDS with laser-induced fluorescence detection (LIF) can significantly expedite methods development and optimization of AAV capsid purity analysis.
FEATURED NEWS HEADLINES
- Ipsen Announces U.S. FDA Priority Review For Palovarotene New Drug Application In Patients With Fibrodysplasia Ossificans Progressiva Following Resubmission
- Mindset Pharma Announces Development Of Novel, Optimized, Intranasal Formulation
- ALX Oncology Receives U.S. FDA Orphan Drug Designation For Evorpacept For The Treatment Of Patients With Acute Myeloid Leukemia
- Accord BioPharma And EVERSANA Announce Partnership To Support The Launch Of CAMCEVI® For The Treatment Of Advanced Prostate Cancer In Adults In The U.S.
- Functional Protein Measuring Technology Could Advance Drug Discovery
- C-Path And Replica Analytics Collaboration Aims To Accelerate Rare Disease Research
- Assessing Drug-Induced Gut Toxicity In Vitro Webinar Announced For July 27
- VeriSIM Life Enters Into Collaboration Agreement With Mayo Clinic To Jointly Advance Drug Discovery And Development Programs
- Schrödinger Announces FDA Clearance Of Investigational New Drug Application For SGR-1505, A MALT1 Inhibitor
- Academic, Industry Leaders Form OpenFold AI Research Consortium To Develop Open Source Software Tools To Understand Biological Systems And Discover New Medicines
ARCHIVED NEWSLETTER
- 07.05.22 -- What Can You Do To Improve Your ADC's Chance Of Clinical Success?
- 06.30.22 -- Simplify And Accelerate The Development Pathway For APIs With Low Solubility
- 06.29.22 -- How MCC Is Transforming mAb Capture
- 06.28.22 -- 3 Tips For Purifying His-Tagged Proteins
- 06.27.22 -- Scale Up Cell Therapy Production At The Pace Of Your Business