Freeze-Drying of Biologicals and Pharmaceuticals Stability by Design

This course will be held on 8 and 9 March 2010 at the Regardz Berghotel, Amersfoort, the Netherlands.

Course Introduction and Aims

• Freeze-drying finds widespread application for the stabilisation of labile biologics and pharmaceutics, with the aims of achieving:
• high product yields
• long term shelf stability at ambient or elevated temperatures
• rapid reconstitution at the time of use

• Despite advances in understanding the processes that that are basic to successful freeze-drying, in practice there are still areas where such understanding is patchy or lacking:
• activity losses during processing and subsequent storage
• the need for long, uneconomical process cycles
• cake collapse and unattractive appearance
• poor reconstitution characteristics
• unpredictable batch-to-batch variability

• Course participants will gain an improved appreciation of:
• the complex interrelationships between formulation, process parameters and final stability of dried products
• how best to coordinate formulation and process development
• freeze-drying as a means of improving product presentation and stability.

Course Structure

The two-day course is divided into 9 teaching modules and will cover the elements necessary for combining theory with practice, process economy with high yield, and product formulation with extended shelf life.

Topics to be covered

• Basic principles of physical and chemical storage stability
• The process in summary
• Physics of low temperature and freezing
• Chemical and biochemical consequences of low temperature and freezing
• Amorphous, water sensitive solids and glass transitions
• Excipient technology
• Ice sublimation and removal of unfrozen water: calculation and measurement
• Elements of heat and mass transfer
• Important aspects of dried products: residual water, solid state reactions, scale up
• Applicable analytical techniques, quality control, stability assessment
• Case histories – common misapprehensions
• Beyond freeze-drying

Who should attend

The course is designed primarily for industrial scientists who are engaged in pharmaceutical development, and particularly in protein production, purification, characterisation, quality control, and setting and measuring protein performance. It will also cater for technologists and engineers charged with the production of new products and processes in which therapeutic drugs form a key element. It will also serve as an update to lawyers active in patent filing, litigation and regulation. Finally, the course is designed to help academic and biomedical researchers and postgraduate students to become familiar with the issues that face those engaged in the fast growing protein industry.

The BioUpdate Foundation is increasingly being invited to supply its approved tutors who will prepare tailor-made courses, usually of one day’s duration, on specific topics for in-house delivery at clients’ locations. Such courses have been held in large and medium sized bio-manufacturing companies, Government institutions, engineering concerns, and law firms, where there is a need for ‘instant bioexpertise’ to cover special IP issues (licensing, drafting, litigation or regulation). For obvious reasons, such course formats are economical for the client companies involved.

For further details, please contact Dr Felix Franks at asdi35@dsl.pipex.com