20th – 21st September 2016. Freeze drying experts at Biopharma present a two-day course on the science and practice of developing products and processes for freeze drying.
- Biopharma has provided expert training courses on biopreservation to industry for a number of years as part of its lyophilisation technical services business. It has therefore established a market leading position in such training that will be provided to the SNAL programme for the benefit of ESRs. The experience spans the bioscience market product base and encompasses the topics related to SNAL programme.
- Practical instruction that can be easily applied to real life situations
- Key concepts relevant to job roles including product research, formulation and process development, quality control, micro biologists, chemists and pharmacists
- Product characterization methods and interpretation and application of analytical data
- Formulating for freeze drying: concepts, key considerations and practical methodology
- Key concept of product freezing including ice structure, cooling rates and supercooling, glass transitions, solute crystallisation, eutectic behaviour, and the use of buffers
- Understanding primary drying: The principles and practicalities of sublimation, controlling heat and mass transfer, understanding and avoiding processing defects
- Temperature Measurement – Methods, equipment and products, design features and pros and cons of different temperature monitoring systems
- Using Freeze Drying Microscopy to determine collapse temperatures, eutectic temperatures, skin / crust formation potential, effects of annealing, and relative rates of sublimation
- Benefits and drawbacks of different types of trays, vials and stoppers
- Systematic cycle development for efficient, reliable processes
- Scaling up to production: formulation, process and equipment issues
- Using Process Analytical Technology (PAT) in development and troubleshooting
- Residual moisture content: effect on stability and shelf life and different analyses
- Benefits of lyophilisation over other stabilization methods
- Proteins: the challenges and complexities posed by these molecules when developing products and processes for freeze drying
- Analysis of freeze dried product demonstrates practical techniques for diagnosing processing failures and discusses methodologies to correct them
21 September 2016
09.00 Welcome & Course Opening
09.15—10.00 Introduction to Freeze Drying Technology. The advantages and challenges of freeze drying.
10.00—10.40 Product Freezing. How ice structure and solute behaviour can affect freeze drying.
Break
11.00—11.45 Primary Drying. The vapour pressure differential; balancing heat and pressure for optimal drying.
11.45-12.30 General Concepts of Formulation. Benefits and drawbacks of different excipients and issues affecting usage.
Lunch (included)
13.30-14.00 Formulation Characterization (1). Use of freeze drying microscopy for determination of critical temperatures.
14.00-14.45 Temperature Measurement. A vital parameter for successful processing—discussion of tools and methods.
Break
15.00-15.40 Formulation Characterization (2). Discussion of thermal methods of analysis including DTA, DSC, Z sin φ.
15.40—16.25 Vials, Stoppers & Barrier Technology. Technologies available and the benefits for different applications.
16.25—17.00 Workshop 1. An exercise to visually assess freeze- dried product and diagnose process defects.
22 September 2016
09.00—09.50 Secondary Drying, PAT & Endpoint Determination. Monitoring & cycle considerations.
09.50—10.40 Cycle Design & Scale-Up. Practical methodologies for developing cycles.
Break
11.00—11.45 Freeze Drying of Proteins. The unique challenges posed by large complex molecules, from characterization to product / process design.
11.40—12.40 Freeze Dried Product Analysis. Methods for analysing freeze-dried product, including moisture determination, thermal analysis and other methods.
Lunch (included)
13.40—16.00 Practical Session in BTL Laboratory. Includes demonstration of freeze drying microscopy, Z sin φ/DTA instruments, DSC, freeze-dryers and moisture analysers.
Please wear clothing appropriate for the laboratory. Gloves, lab coats and eye protection will be provided.
Discounts available for group booking and academia.
Contact Sally Potentier for more information: [email protected]
Please note that the cost of accommodation is not included in the course fee and that bedroom bookings must be made by the participants. A list of recommended local hotels will be provided with the delegate information. Fees include morning and afternoon breaks, lunch, evening welcome reception and full lecture notes.
Other course types and locations are available.
See biopharma.co.uk/training-courses for more information.
Email to: [email protected]
Book online at www.biopharma.co.uk/training-courses/ or
Fax to: +44 (0)1962 841147
This course is held at our facility in Winchester in the south of England, conveniently close to many transport hubs including London international airports. A session inside our main laboratory takes place on day 2, which includes introduction and demonstration of some of the equipment we use. A list of local recommended hotels will be sent with the delegate information pack. Attendees are requested to make their own reservations.
Address: Biopharma House Winnall Valley Road, Winchester SO23 0LD, UK
+44 (0)1962 841092
