Shadow AI and vendor data retention put GMP records and trade secrets at risk. AI Pulse Check panelists outline what pharma AI policies require.
News|Articles|May 2, 2014
- Pharmaceutical Technology-05-02-2014
- Volume 38
- Issue 5
Mass Spectrometer Enhances Performance in Protein Analysis
Mass Spectrometer Enhances Performance in Protein Analysis
The autoflex speed from Bruker is the newest member in the Flex series of MALDI-TO F (/TO F) mass spectrometers. The system incorporates numerous technology advancements that provide enhanced data quality, acquisition speed, mass and dynamicrange, and performance. The autoflex speed is designed to improve the productivity of laboratories involved in protein sequencing, biomarker discovery, polymer analysis, lipid and glycan analysis, molecular imaging, drug and metabolite tissue distribution, as well as high-throughput MALDI Biotyper microbiological molecular identification. System configurations can be adjusted for a number of analytical operations and environments using both TO F and TO F/TO F modes in combination with hardware and software tools for a variety of proteomics, imaging, polymer, and small molecule applications.
Articles in this issue
over 12 years ago
Extractables and Leachables Testingover 12 years ago
Data Integrity in the Analytical Laboratoryover 12 years ago
Q&A with Tony Mitchell, Pharma Tech Industriesover 12 years ago
Linking Drug Shortages and Quality Metricsover 12 years ago
EU Steps Up Inspection Effortsover 12 years ago
Aggregation System Improves Analysis of Sub-Visible Particlesover 12 years ago
Boosting New Antibiotic Drug Development in Europeover 12 years ago
Freeze Drying Protein FormulationsRelated to this article
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.