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.
List view / Grid view
Articles
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.
Shehnaaz Suliman Theravance Biopharma: ‘Being a healer in the face of inequality’
As part of EPR’s Women Inspiring Pharma series, Shehnaaz Suliman, SVP, Business Development and Strategy, Theravance Biopharma talks to Science Editor Dr Zara Kassam about fighting for human rights, inequality and the challenges women face in their careers...
Solid-state NMR spectroscopy: predicting stability in lyophilised biological products
The emergence of biological drugs has led to an increase in lyophilised drug products in the market. Lyophilisation is a technique used to stabilise parenteral formulations in a solid form with the goal of producing chemically and physically stable, homogeneous, and high-quality lyo-products.
LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics
For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…
Brexit – will all the medicines get to the patients?
Two years after the UK narrowly voted to exit the EU it remains unclear as to what this may involve. In July 2016, Theresa May stated that “Brexit means Brexit.” But what exactly did that mean?
Integrating data from QC and Production to enable fast, informed decisions
Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…
NIR inspection of each tablet that exits a tablet press
In the pharmaceutical industry, waste represents at least 25% of the cost of quality. In 2004, the Food and Drug Administration (FDA) published a guide to promote the implementation of Process Analytical Technologies (PATs) in the pharmaceutical industry. This would allow better quality control (QC) and monitoring directly on the…
RCPE: Spotlight on… Continuous Manufacturing
In this Spotlight on Continuous Manufacturing, RCPE facilitates the adoption of novel manufacturing technologies...
Evaluation of microbiological purified water trend using two types of control chart
The microbial population in water is dynamic and may change not only from day to day but also at different times of the day. Researchers have observed that this microbiological distribution usually follows the Poisson or Negative Binomial model.1
Wickham Laboratories: Drawing on deep technical expertise
Wickham Laboratories draws on deep technical expertise, backed by decades of global experience, when identifying challenges and providing solutions for a broad range of products and testing scenarios.
Siemens: Spotlight on… Continuous Manufacturing
In this Spotlight on Continuous Manufacturing, Siemens offers pharmaceutical companies a unique portfolio of products (hardware and software), systems, solutions, and service – considering GxP* regulations – over the entire plant life cycle – as well as professional experience and interdisciplinary expertise...
Taking a collaborative approach to continuous pharmaceutical manufacturing
Offering increased yields, lower utility consumption and reduced waste, continuous manufacturing presents a paradigm shift in drug production and meets the pharmaceutical industry’s demands for faster product development, reduced costs, improved production economics and increased flexibility.
Burkholderia cepacia complex: review of origins, risks and test methodologies
Burkholderia cepacia complex (BCC) isolates are causes of healthcare-associated infection, especially in relation to contamination of aqueous inhalers and some intravenously administered products. The bacterial species can cause opportunistic infections in vulnerable individuals, especially those with cystic fibrosis (CF)
Eurofins: The largest scope of global services. The sharpest focus on data integrity.
Eurofins BioPharma Product Testing’s facilities deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
