BTL: An Introduction
- 2. Synopsis • Introduction to BTL • Services • Analytical Instruments • Training Courses • R&D Projects
- 4. History of BTL • BTL was founded in 1997 • Our goals are: – To assist customers with formulation – To develop freeze-drying cycles – To provide instruments for characterisation – To run training courses in freeze-drying – To conduct our own research & development projects in freeze-drying
- 5. The Management Team Dr Kevin Ward Ph.D. MRSC Director R&D – joined BTL in 2000 Dr Laura Ciccolini Ph.D. M.Eng. Commercial Director – joined BTL in 2011
- 6. Services
- 7. Product Characterisation • Pre and post freeze-drying analysis of formulations using: – BTL Lyostat3 freeze-drying microscope – BTL Lyotherm2 combined thermal analyser – TA Modulated DSC – Karl Fischer moisture titration – FMS headspace moisture analysis
- 8. Formulation Development • To date, BTL has worked with over 700 products, from small molecules to proteins, organisms, whole cells, collagen products, blood and archaeological samples • We are proud to have contributed to the development of important products • We aim for 100% customer satisfaction, helping customers choose the right formulation that will give an active and stable freeze-dried product
- 9. Freeze-Drying Cycle Development • BTL develops freeze-drying cycles that are tailored to the needs of each specific product • We aim for all cycles to be efficient, robust and suitable for scale-up • We base our cycle development on important formulation parameters, which we analyse using our Lyostat3 Freeze-Drying Microscope and Lyotherm2 Thermal and Impedance Analyser
- 10. Small Scale Production • Customers own cycle or one developed by BTL • We can ship vials, boxes, trays, etc • Samples are suitable for ongoing R&D, intermediates and diagnostics. • Samples are non-GMP rated
- 11. New facility for cytotoxic compounds • Product analysis, cycle and formulation development can be offered for cytotoxic material • Dedicated suite means no chance of cross- contamination with non-cytotoxic products
- 14. Impedance analysis / DTA Lyotherm2
- 15. Training Courses
- 16. Training Courses • Since 1997, we have run more than 120 training courses in freeze-drying • We have trained more than 2,500 people • We offer 2-day courses focusing on the Product and the Process • We offer 3-day courses covering Product, Process, Equipment Design & Qualification • We also offer on-site courses for customers
- 17. R&D Projects
- 18. BTL’s own R&D projects • Freeze-drying of Red Blood Cells • Freeze-drying of Collagen implants for knee repair surgery • Freeze-drying of Probiotic bacteria • Freeze-drying and polymorphism to increase herbicide efficiency • Freeze-drying of Fusion Proteins as intelligent insecticides
- 19. Biopharma House, Winnall Valley Road, Winchester SO23 0LD, UK Tel: +44 (0)1962 841092 Web: www.btl-solutions.net