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# Lyophilisation

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.

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### PCI Pharma Services announces major manufacturing expansion with $100 Million investment in New England, providing global capacity to clients 20 May 2022 | By Capabilities include the latest in sterile lyophilisation and liquid filling technology to support global pharmaceutical supply chain, keeping pace with industry trends. news ### X-ray imaging enables automated parenteral product particulate inspection 25 October 2021 | By 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. news ### FTIR, NIR and Raman – advantages and disadvantages for protein characterisation 27 August 2021 | By 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. article ### The importance of disaccharide excipients in biologics 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… news ### Importance of sublimation tests when freeze-drying HPAPIs shown in study 25 September 2020 | By Researchers have shown that sublimation tests should be conducted if new components are added to the freeze-drying process of HPAPIs. news ### Telstar promotes aseptic technology developments for pharma production 4 November 2019 | By 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. article ### Tuberculosis: fighting the disease with a single vial 13 May 2019 | By , 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. product ### Eurofins Amatsigroup ǀ Your cDmo partner 1 November 2018 | By Frédéric Gaussens from Eurofins Amatsigroup (CDMO) giving an overview of the services they provide... article ### Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs 22 August 2017 | By , 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… article ### The importance of being small: miniaturisation of freeze drying equipment 18 August 2017 | By , 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… news ### Patheon to invest$45 million in spray drying & manufacturing solutions

5 July 2017 | By

Patheon expects to invest approximately \$45 million at key sites across its network in spray drying capabilities and flexible manufacturing solutions...

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### Linkam launches a new platform to replicate large scale freeze drying systems

16 November 2016 | By

Linkam Scientific Instruments, announce the launch of the FDVS platform, a lyophilisation system to replicate large scale freeze drying processes...

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### How & why to build a QbD process to optimise the efficiency of your freeze drying projects

1 July 2016 | By

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...

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### PAT Series: Recent achievements in NIR-based on-line monitoring of lyophilisation processes

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…

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### How to avoid residual solvent when drying reverse phase HPLC fractions and prevent the formation of gums and oils.

26 February 2016 | By

Traditional concentration of reverse phase HPLC fractions to dryness in a Genevac HT evaporator is a fast and safe process...