List view / Grid view
21 February 2019 | By Telstar
The pharmaceutical industry is increasingly using different sterilisation technologies rather than steam sterilisation. This increase is driven by the need for sterilising thermo-labile products or areas that cannot be dimensioned as a pressure vessel (barrier systems such as Closed Restricted Access Areas or Isolators), under “softer” conditions.
24 January 2019 | By Nikki Withers (European Pharmaceutical Review)
A vaccine that does not require a cold chain could be much more easily distributed to communities in need…
18 January 2019 | By Henning Gieseler, Julia Kosan
Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…
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.
22 October 2018 | By European Pharmaceutical Review
In this issue: LC-MS multi-attribute methods for the characterising and QC testing therapeutics, integrating data from Quality Control and Production to enable fast and informed decisions, and Solid-state NMR spectroscopy: using freeze drying to predict the stability of biological products.
25 January 2018 | By Linkam Scientific Instruments Limited
Market leaders in temperature controlled microscopy and established manufacturers of advanced freeze drying microscopes, Linkam Scientific Instruments, report on the work of Dr Henning Gieseler from the Friedrich-Alexander University (FAU) Erlangen-Nuremberg on his research and development activities in the field of freeze drying for the pharmaceutical industry.
2 January 2018 | By Jos Corver, Pieter-Jan Van Bockstal, Thomas De Beer
Among the list of over 300 FDA and EMA approved biopharmaceutical products, around 50% are freeze-dried – indicating that freeze-drying is the preferred way of stabilising biopharmaceutical drug products that are unstable in aqueous solution, despite the high cost and long processing time linked to this manufacturing technique.1,2
12 September 2017 | By Steve Bremer (European Pharmaceutical Review)
Dr Paul Royall, Senior Lecturer in Pharmaceutics at King’s College London, and Programme Director of the MSc in Pharmaceutical Analysis and Quality Control, has joined European Pharmaceutical Review's Editorial Advisory Board.
25 August 2017 | By European Pharmaceutical Review
In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...
22 August 2017 | By Abdulmalik Alqurshi, Paul Royall
A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…
21 August 2017 | By Yves Mayeresse
This article reviews the trends in freeze drying highlighted at recent Parenteral Drug Association (PDA) conferences...
18 August 2017 | By Henning Gieseler, Margit Gieseler
Developmental activities for freeze-dried products are dictated by the limited availability and high cost of newly developed active compounds, and by Quality-by-Design requirements. Laboratory-scale freeze dryers used for formulation and process development show an excessive variety of designs and instrumentation concepts, making scale-up activities a challenge. The development of miniaturised…
17 August 2017 | By European Pharmaceutical Review
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
Follow: