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17 December 2018 | By European Pharmaceutical Review
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.
9 November 2018 | By Dr Zara Kassam (European Pharmaceutical Review)
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...
2 November 2018 | By Ashley Lay (University of Kentucky), Eric J. Munson Professor and Head of the Department of Industrial and Physical Pharmacy at Purdue University, Yongchao Su (Associate Principal Scientist in Pharmaceutical Sciences-Merck)
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.
2 November 2018 | By Ioannis A. Papayannopoulos (Celldex Therapeutics Inc.)
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…
2 November 2018 | By Paul Gershlick (Partner and Head of Pharma & Life Sciences - VWV)
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?
2 November 2018 | By Sinéad Cowman - EU Business Development Manager at Informatics - Lonza
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…
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…
30 October 2018 | By Mostafa Eissa (Hikma Pharmaceuticals)
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
30 October 2018 | By Wickham Laboratories
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.
30 October 2018 | By Siemens
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...
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.
29 October 2018 | By Tim Sandle
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)
29 October 2018 | By Eurofins
Eurofins BioPharma Product Testing’s facilities deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.