Biopharma Technology Ltd.

Synopsis

• Introduction to BTL

• Services

• Analytical Instruments

• Training Courses

• R&D Projects

Introduction to BTL

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

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

Services

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

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

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

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

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

Analytical Instruments

Freeze-Drying Microscope Lyostat3

Impedance analysis / DTA Lyotherm2

Training Courses

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

R&D Projects

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

Biopharma House, Winnall Valley Road, Winchester SO23 0LD, UK

Tel: +44 (0)1962 841092 Web: www.btl-solutions.net