Recommended

Novo Nordisk bids $6.5bn for Metsera Therapeutics
MHRA to streamline UK rare disease drug regulatory pathway
Lilly invests €2.6bn in Netherlands manufacturing facility
MHRA recruits first Chief Medical and Scientific Officer
Galapagos to exit cell therapy business
Chiesi expands French metered dose inhaler facility
CPHI Milan to add AI zone for 2026
Hovione invests $100m in US spray drying manufacturing

List view / Grid view

QA/QC

 

Figure 1 Comparison between the spectra derived from a 5μm polystyrene bead using either standard Raman spectroscopy (A) or modulated Raman spectroscopy (B)
Figure 1 Comparison between the spectra derived from a 5μm polystyrene bead using either standard Raman spectroscopy (A) or modulated Raman spectroscopy (B)
article

Raman spectroscopy and cancer cells

19 August 2010 | By Andrew Riches, Professor of Experimental Pathology, School of Medicine, University of St. Andrews and Co-authors: C. Simon Herrington, School of Medicine Kishan Dholakia, Elisabetta Canetta, Antonia Carruthers, Michael Mazilu, Anna Chiara de Luca, School of Physics & Astronomy Chris Goodman, Greg Kata, Nabi Ghulam, Kadi Nourdin, Department of Urology, Ninewells Hospital & Medical School, Dundee

Raman spectroscopy has the potential to provide diagnostic information to the clinician. The technique has a number of advantages allowing individual cells to be interrogated without staining. With further developments in technology, the surgeon will be able to rapidly acquire accurate diagnostic information at the time of operation using fibre…

Figure 1 Packing diagrams showing the different molecular arrangements in polymorphs A (left) and B (right) of the antipsychotic drug risperidone (centre). Unit cell parameters for each polymorph are shown.
Figure 1 Packing diagrams showing the different molecular arrangements in polymorphs A (left) and B (right) of the antipsychotic drug risperidone (centre). Unit cell parameters for each polymorph are shown.
article

Polymorph screening in pharmaceutical development

19 August 2010 | By Professor Alastair J. Florence, Solid-State Research Group, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde

The majority of active pharmaceutical ingredients (APIs) are produced by crystallisation and so the phenomenon of polymorphism, whereby an organic molecule can adopt more than one crystalline form (Figure 1), is of considerable importance when trying to achieve consistent product quality during the manufacture of pharmaceutical solids and solid dosage…

Figure 3
Figure 3
article

Raman spectroscopy for the analysis of drug products and drug manufacturing processes

9 May 2010 | By Prof. Thomas De Beer, Assistant-Professor, Process Analytical Technology, Faculty of Pharmaceutical Sciences, University of Ghent

This article aims at supplying a concise overview on the application of Raman spectroscopic analysis methods within the pharmaceutical drug product manufacturing world. Firstly, there will be a focus on the rapid and nondestructive off-line analysis feasibility of Raman spectroscopy for final drug products. Herewith, several possible sources of error…

article

A sensitive and selective vibrational spectroscopy technique in life sciences

12 December 2009 | By

At present, the relevance of Raman Spectroscopy (RS) as an analytical tool in pharmaceutical sciences is increasingly obvious. RS is a mode of vibrational spectroscopy based on inelastic scattering of laser light and, like infrared spectroscopy (IR), provides detailed molecular structure information (see Figure 1A). However, contrary to IR, it…

article

Raman spectroscopy in pharmaceutical analysis

9 October 2009 | By

A wide and versatile range of analytical techniques are routinely used, indeed are necessary, in pharmaceutical analysis. Over the past decade Raman spectroscopy has increasingly come to the fore as a valuable member of the arsenal of methods used, from both a fundamental and applied perspective, for the interrogation of…

P{ills and tablets
P{ills and tablets
article

QbD and PAT: From Science to Compliance

30 July 2009 | By Pedro E. Hernandez-Abad, Associate Director; Jun Huang, Principal PAT Scientist II and Saly Romero-Torres, Principal PAT Scientist, both Wyeth Pharmaceuticals

Boards of health like the Food and Drug Administration and European Medicines Agency and ICH guidelines Q8, Q9 and Q10, provide a framework for Quality by Design (QbD) that fully integrates drug substance and drug product development with the principles of Quality Risk Management (QRM), Process Analytical Technology (PAT) and…

article

Raman spectroscopic techniques for biotechnology and bioprocessing

7 February 2009 | By

Biotechnological expertise is becoming increasingly important within the pharmaceutical industry, and will play a pivotal role in the monitoring of fermentations, particularly their optimisation within the framework of Process Analytical Technologies (PAT). The ability to harness biological processes for the development of drug therapies, so called ‘biopharmaceuticals’ provides treatments that…

Purple pills, tablets
Purple pills, tablets
article

Successful Process Analytical Technology (PAT) implementation in pharmaceutical manufacturing

29 September 2008 | By Thirunellai G. Venkateshwaran (Senior Director, New Products Quality, Global Quality and Compliance), John Levins (Senior Director, Technology Transfer & Process Innovation) and Stephen P. Simmons (Head of New Product Quality and Quality by Design), all Wyeth Pharmaceuticals

The use of Process Analytical Technology (PAT) while a relatively new concept to the Pharmaceutical Industry has been a tried and tested concept in the petrochemical industry for many years. The adaptation of PAT systems by the Pharmaceutical Industry was accelerated by the recent initiatives of the regulatory authorities globally…

article

Advanced Aseptic Processing: RABS and Isolator Operations

2 August 2008 | By

Advanced Aseptic Processing (AAP) is a term referenced in the recently published ISPE RABS definition1 to cover the spectrum of Restricted Access Barrier Systems (RABS) and isolator systems. In general, AAP techniques are physical barrier methods of product protection and containment that are used during manufacturing operations to separate (primarily)…

article

Siemens: innovation, industry and implementation

19 June 2008 | By

Siemens seeks to deliver breakthrough innovations to give customers a unique competitive edge, in turn enabling societies to master their most vital challenges and creating sustainable value. Siemens was one of the first suppliers to adopt the new guidelines of the Food & Drug Administration (FDA) and the European Agency…

article

QbD and PAT – 2008 is the year it goes mainstream

7 April 2008 | By

Since the FDA revolutionary white papers[1,2] in 2004, the industry has talked non-stop about the potential of PAT (Process Analytical Technology) and more recently, QbD (Quality by Design). These topics have found regular spots in conferences, press and internal company discussions. It has been widely stated3 that the benefits are…

article

Pharmaceutical analysis in quality control

7 April 2008 | By

Pharmaceutical analysis in drug development mainly focuses on methods to identify and quantify potential new drug candidates, determine purity, identify by – products and degradation products in compatibility and stability studies, and to determine the drug substance’s fate in the organism. Challenging tasks like these require sophisticated techniques, dedicated equipment…