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Pharmaceutical companies often use lyophilisation (or freeze-drying) to increase the shelf life of the products, such as live virus vaccines, biologics and other injectables. By removing the water from the material and sealing the material in a glass vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. Another example from the pharmaceutical industry is in tablet or wafer production, the advantage of which is less excipient as well as a rapidly absorbed and easily administered dosage form.
Lyophilisation is also used in manufacturing of raw materials for pharmaceutical products. Active Pharmaceutical Product Ingredients (APIs) are lyophilised to achieve chemical stability under room temperature storage. Bulk freeze-drying of APIs is typically conducted using trays instead of glass vials.
Dry powders of probiotics are often produced by bulk lyophilisation of live microorganisms such as Lactic acid bacteria and Bifidobacteria.
Light-assisted drying (LAD) is a new optical processing technique for forming trehalose amorphous solids to preserve biologics, while avoiding the freezing step necessary for lyophilisation.
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Capabilities include the latest in sterile lyophilisation and liquid filling technology to support global pharmaceutical supply chain, keeping pace with industry trends.
X-ray imaging was able to detect all common particulates in lyophilised drug product and provide information of the cake structure in a new study.
Here, EPR summarises a review of some of the benefits and disadvantages for spectroscopic techniques used to characterise the structure of therapeutic proteins in solid dosage forms.
Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…
Researchers have shown that sublimation tests should be conducted if new components are added to the freeze-drying process of HPAPIs.
At CPhI (Frankfurt, November 5-7 2019), Telstar will be promoting the latest solutions in isolation technology systems, sterilisation and pharmaceutical freeze-drying applications, designed to ensure an aseptic and efficient production of pharmaceutical processes.
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.
Frédéric Gaussens from Eurofins Amatsigroup (CDMO) giving an overview of the services they provide...
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…
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…
Patheon expects to invest approximately $45 million at key sites across its network in spray drying capabilities and flexible manufacturing solutions...
Linkam Scientific Instruments, announce the launch of the FDVS platform, a lyophilisation system to replicate large scale freeze drying processes...
Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself...
30 June 2016 | By Adrian Funke - Bayer Pharma AG / Reinhard Gross, Stephan Tosch and Albert Tulke - Bayer Technology GmbH
Process analytical technology (PAT), namely near-infrared (NIR) and Raman spectroscopy, has already been shown to be a useful tool for monitoring, analysing and optimising the complex process of lyophilisation. The latter process is especially challenging in the case of biopharmaceutical formulations due to the instability of active ingredients, leading to…
