Company : Biopharma Technology Ltd

Category : Contract Services

Key Products : Analytical instruments, Formulation and Cycle Development

 

BTL has provided contract R&D services, training, and advanced instrumentation in freeze drying since 1997. They have decades of experience in the application of all aspects of freeze drying technology and have successfully processed over 750 substances on behalf of clients, from small drug molecules, large complex biomolecules, living organisms, foods, tissues, and more. Together with their knowledge of pilot-scale and industrial freeze-dryers they offer a uniquely comprehensive service covering all aspects of freeze-drying from pre-formulation through to full-scale production and dried product analysis. Their philosophy is to augment in-house expertise and work with you to make your project a success.

Freeze Drying

A rational approach to designing and developing freeze drying formulations and cycles requires information about how the product responds to different processing conditions. Understanding the behavior of a product throughout the freeze drying process ensures that cycles can be developed that are tailored to the specific needs of each product, making them efficient, safe, robust and reproducible.  Characterization also provides data which is useful for quality control and regulatory submissions. BTL uses a range of analyses to thoroughly characterize their product, including Freeze Drying Microscopy, DTA and Impedance Analysis, modulated DSC, Karl Fischer, and Frequency Modulated Spectroscopy.

Formulation Development

A well-designed formulation will protect the product from the stresses of freeze drying. It will also ensure a thermal profile that is favorable for freeze drying. BTL has decades of experience designing formulations for all types of products and an extensive knowledge of excipients. Freeze drying cycles should be efficient, reliable and safe for product and personnel. The development of a cycle should be undertaken rationally, using detailing information about the product’s thermal profile and the production equipment. After analyzing your product BTL can design a cycle that meets all these criteria in typically just 3 runs. 

Process Development

BTL has world-renowned expertise in freeze drying and they pride themselves on offering the most thorough and up-to-date Freeze Drying Training courses for the Pharmaceutical / Biotechnology industries. They have been conducting training courses in freeze drying technology since 1997. Their training courses are designed to give participants an in-depth understanding of the theory and applications of lyophilization. The courses have been designed and developed to benefit those working in lyophilization, whether new to the subject or experienced, and across a variety of disciplines and job roles. They present the knowledge from practice and experience – not just text books.

Scale-Up and Optimization

Freeze drying cycles are designed with specific product, formulation, batch and equipment parameters in mind. A change in any of these may affect the behavior of the product during the cycle, or may make the cycle inefficient.  Production dryers typically have different capabilities to smaller R&D systems in terms of achievable temperatures, condenser load and process energy. A cycle that is optimized for the lab may not be suitable or even possible on larger systems. For these reasons BTL offers process optimization and scale-up services, to ensure that your process is right for your product and equipment.

Successful Freeze Drying

BTL have developed two advanced analytical instruments - the Lyostat freeze-drying microscope and the Lyotherm DTA and electrical resistance analyzer. Lyostat identifies eutectic / collapse temperatures, crystallization events, and the effects of annealing. Lyotherm investigates changes within the frozen product. This provides information such as glass transition and melting temperatures. It can also show endothermic and exothermic events occurring within the frozen sample, such as crystallizations and eutectic melting, which may have serious impacts on processing and stability of your product. Together these instruments provide vital information about the product which is necessary for successful formulation and process development. 

Contact Details

Biopharma Technology Ltd
Biopharma House
Winnall Valley Road
Winchester SO23 0LD
United Kingdom.
Phone: +44 (0)1962 841 092
Fax: +44 (0)1962 841 147
Email: btl@biopharma.co.uk
Website: www.biopharma.co.uk

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