news
Correcting minority underrepresentation in MS clinical trials
Minority underrepresentation in clinical trials for drugs to treat MS has led to doctors being unable to make informed decisions when prescribing...
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Analytical techniques
news
Tailor-made excipients, developed the Kolb way
Standard excipients can be sourced from various suppliers, but what if you need to customise an excipient to suit your needs?
article
Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
whitepaper
Whitepaper: Logistic regression model of the endotoxin standard curve and statistical tests
The Monocyte Activation Test (MAT) is used to detect or quantify pyrogenic substances that activate human monocytes.
article
Expert View: Raman imaging and spectral database management for pharmaceutics
Sophisticated hardware and software offer speed and precision. Pharmaceutical development often involves samples in solution or on transparent substrates. For these applications, confocal Raman imaging using an inverted beam path is an especially versatile and powerful investigative method.
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Expert View: What ADC evolution means for manufacturing
The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…
product
Product Hub: High sensitivity pyrogen testing with the PyroMAT™ system: make the move to the next MAT generation
Used to detect a broad range of pyrogens in parenteral products including pharmaceuticals, biopharmaceuticals and medical devices, the Monocyte Activation Test (MAT) gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.
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Raman In-Depth Focus 2018
This In-Depth Focus covers drop-coating deposition Raman (DCDR) spectroscopy for metabolite profiling and recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines.
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Issue 6, 2018
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
news
Predictions of early responses in paediatric acute lymphoblastic leukaemia
Researchers have identified markers of pediatric acute lymphoblastic leukaemia to predict early relapses by testing levels of nucleotide excision repair...
news
Ensuring supplier and compounded drug quality
It is paramount that manufacturers and their suppliers ensure that the quality of compounded drugs are high, by preventing risks of contamination...
news
Data integrity and compliance with drug current good manufacturing practices
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to...
whitepaper
Application Note: The future of water is clear
Taking advantage of technology developed in recent years, MECO announces smartANALYTICS™ as a means of connecting its water purification machines and systems with big data analytics and in-house expertise.
product
Solution stable trypsin at HPLC 2018
SOLu-Trypsin is an Advanced Proteomics Grade enzyme that is solution stable for mass spectrometry.
