Freeze Drying: - The Biopharma Group

Freeze Drying:
A Practical Guide to Process Development
20th-21st October 2015 | Biopharma House, Winchester, UK | £995
Freeze drying experts BTL present a two-day course on the science and practice
of developing products and processes for freeze drying.
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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 unique 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
Biopharma Technology Ltd | IntelligentFreezeDrying.com | +44 1962 841092 | [email protected]
About BTL
Biopharma Technology Ltd (BTL) has provided specialist services in freeze drying since 1997. We have worked
with over 1000 products, from small drug molecules to large complex biomolecules, cells, tissues and even some
more unusual products such as archaeological artefacts. As well as R&D, consultancy and training, we also worked
to develop analytical instruments that would provide additional in-depth information for product and process
development: the Lyostat freeze drying microscope and Lyotherm frozen state analyser. We continually participate
in research projects to further the science and our understanding of freeze drying, with projects including red blood
cells, collagen scaffolds and probiotics.
Thomas Peacock MSc
Dr Andrew Ingham
Dr Kevin Ward
After an MSc in Pharmaceutical
Analysis Tom specialised in the field of
lyophilisation. Tom has managed many
commercial freeze-drying projects
typically involving formulation
development and characterisation,
looking at key product factors and
designing robust
and efficient
cycles. Tom has
significant
expertise in
freeze drying
microscopy and
has travelled
widely lecturing
on freeze drying.
Dr Ingham is lead for the undergraduate
pharmacy programme at Aston
University. He looks after over 600
students spread across all four years of
the programme as well as teaching
overseas pharmacists for qualifications.
His research interests are focused in the
area of
lyophilisation with
key interests in:
bulk powder flow,
biosynthetic protein
protection for long
term storage and
osmotic formulation
of intravenous
injections.
Kevin was awarded his PhD for studies
in pharmaceutical freeze-drying,
focusing on the use of protective agents
in formulations of proteins and
liposomes for drug and vaccine delivery.
He has worked in the pharmaceutical
industry and as a research fellow in
vaccine
development. Kevin
is R&D Director at
BTL and regularly
lectures on the
freeze drying
process as well as
analytical and
process related
issues.
Venue
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.
Biopharma House
Winnall Valley Road, Winchester SO23 0LD, UK
+44 1962 841092 [email protected]
Freeze Drying : Practical Guide to Process Development | October 2015 | intelligentfreezedrying.com
Timetable
Day 1
Day 2
09.00 Welcome & Course Opening
09.00—09.50 Secondary Drying, PAT & Endpoint Determination
Monitoring & cycle considerations
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
09.50—10.40 Cycle Design & Scale-Up Practical methodologies for
developing cycles
Break
Break
11.00—11.45 Primary Drying The vapour pressure differential;
balancing heat and pressure for optimal drying
11.00—11.45 Freeze Drying of Proteins The unique challenges posed by
large complex molecules, from characterization to product / process design
11.45-12.30 General Concepts of Formulation Benefits and
drawbacks of different excipients and issues affecting usage
11.40—12.40 Freeze Dried Product Analysis Methods for analysing
freeze-dried product, including moisture determination, thermal analysis and
other methods
Lunch (included)
13.30-14.00 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
Lunch (included)
13.40—16.00 Practical Session in BTL Laboratory Includes
demonstration of freeze drying microscopy, Zsinφ/DTA instruments, DSC,
freeze-dryers and moisture analysers. Please wear clothing appropriate for
the laboratory. Gloves, lab coats and eye protection will be provided.
Break
15.00-15.40 Formulation Characterization (2) Discussion of thermal
methods of analysis including DTA, DSC, Zsinφ
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
Timetable shown is representative and may be subject to change.
Freeze Drying : Practical Guide to Process Development | October 2015 | intelligentfreezedrying.com
Course details and booking form
Date:
20th-21st October 2015
Location: Biopharma House. Winnall Valley Road,
Winchester SO23 0LD
Phone: +44 1962 841092
Fees: £995
Early Bird Rate: £875
Book & Pay by 5th September to qualify. Discounts also
available for group booking and academia. Contact Sally
Potentier for more information: [email protected]
Name
Job Title
Organisation
Address
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 and full lecture
notes.
Other course types and locations are also available —see
biopharma.co.uk/training-courses for more.
Invoice
Address
(if different)
Phone
Fax
Email
Please
reserve
places
Fax to: +44 1962 841147 Email to: [email protected] or book online at
www.biopharma.co.uk/training-courses/
Payment must be made in full 4 weeks before the start of the course.
Payment by BACS or credit/debit card is acceptable—please note we
cannot accept payment by check. An invoice will be issued on receipt of
booking. Payments in credit/debit card will be charged at the prevailing
exchange rate as set by xe.com. An invoice will be issued on receipt of
booking.
Discounts are also available for academia and multiple bookings from the
same company, please contact us for details.
Cancellation in writing more than 5 weeks before the course start date will
incur a service charge of 30% of the applicable fee. No refunds can be
made for cancellation after this date. Substitutes will be accepted at any
time.
Full T&Cs available on request.
Biopharma Technology Ltd. Biopharma House,
Winnall Valley Road, Winchester SO23 0LD, UK.
+44 1962 841092 [email protected]
Intelligentfreezedrying.com or biopharma.co.uk