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This article focuses on how formulation data can be utilised to create optimal freeze-drying cycles for a specific product based on the unique process analytical technology (PAT) tools and technologies available in SP Scientific’s LyoStar™ 3, a leading freeze dryer for cycle development.
Vaccinations have begun in a phase I human clinical trial testing a freeze-dried, temperature-stable formulation of an experimental tuberculosis vaccine candidate. Nikki Withers speaks to Dr Daniel Hoft and Christopher Fox about the formulation process and what this means for vaccine development going forward.
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
Lyogistics Zero, the only freeze dryer vial automatic loading/unloading system with the ability to have CIP/SIP inside the chamber, and Lyonuc, the new vacuum nucleation induction method suitable for any type of freeze-dryer, are leading cutting-edge solutions for pharma processes…
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.
A vaccine that does not require a cold chain could be much more easily distributed to communities in need…
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.…
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.
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.
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.
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
Senior Lecturer in Pharmaceutics at King's College London
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.
In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...
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…
