Lyophilisation Africa Summit

“Undertaking Current Best Practices in Your Freeze Drying Techniques”

Holiday Inn, Sandton, Johannesburg, South Africa

17th to 18th of September-2014
Biologically manufactured products like proteins, vaccines and other injectables are supposed to be effective
from the day they are manufactured to the day they are supposed to be consumed since such products are
expensive and fragile and can easily lose their efficacy at the time of storage.
Researchers on freeze-drying techniques of pharmaceuticals and biological products will get together to discuss
the most important aspects and new developments Lyophilisation specifically on material sciences, biotech
formulation, technical operations and PAT.
Valuable biological and food products be stabilised through the process of dehydration. The pharmaceutical
freeze drying process is often called lyophilisation and is mostly undertaken in controlled environments in
compliance with strict regulatory guidelines. Successful lyophilisation is able to extend the shelf life of the
product and prevents many bio pharmaceutical and food products from degrading. The challenge is mostly in
controlling the nucleation temperature which is the temperature at which the biological vial freezes.

Benefits of Attending the Summit

 Improving, transferring technologies and results from the lab to major production centres
 Creating optimum formulations to speed up the freeze drying process.
 Advancing and promoting homogeneity and compliance with key regulations
 Implementing PAT and QbD approaches at the same time as these two methodologies are quite complex
and need to be well understood.
 Discussing the costs versus benefits of optimising the lyophilisation process
 Evaluating and undertaking mathematical modelling in freeze drying processes
 Gaining insight into imaging analysis as a support tool for your freeze drying cycle
 Analysing process techniques that are employed in product visualisation during the freeze drying approach
 Assessing the application of non-conventional formulation techniques and methodologies
 Applying moisture control and dried vaccine formulations

Who Should Attend

 The Conference is targeting Professionals who are involved in
 Pharmaceutical and biological storage
 Freeze-drying and lyophilisation
 Research and Development
 Chemical Engineering
 Sterility
 Product Development
 Business Development
 Quality Assurance and quality Control
 Protein stabilisation
 Cold Chain distribution
 Freeze-drying manufacturers
 Vaccine Storage
 Clinical Trial logistics
 Regulatory Compliance

Day One: 17th September, 2014

08:00: Registration & Morning Refreshments

08:30 An overview of freeze-drying/lyophilisation of biological products
 Understanding lyophilisation
 Principles relating to formulation of lyo products
 Stability issues involved in lyo products
 What to take into account for biologics in their dry state

Esco Technologies,
Pharmaceutical Containment
South Africa

 09:15 Lyophilisation of Proteins and other pharmaceuticals-Process: Formulation and Stability

 Understanding Formulations
 Container closure selection and preparations
 Robustness of the lyophilisation cycle
 Developing a robust lyophilisation process
Professor Dale Gyure,
Division Head of Manufacturing
National Bioproducts Institute,
South Africa

10:00 Morning Refreshments

10:30 Understanding the bottlenecks of drying method selection for protein pharmaceuticals and its impact on
product quality
11:15 Examining the Available Alternatives to Freeze-Drying Processes.
Dr. Loveness K. Nyanga,
Chairperson, Lecturer,
Institute of Food, Nutrition and Family Sciences,
University of Zimbabwe

12:00 Assessing the impact of thermal treatment on stability of freeze dried amorphous Pharmaceuticals
13:00 Network Lunch
14:00 Works/Developments on Freeze drying as well as on terminational radiation sterlization
Florent Kuntz
Project Manager
Aerial Crt
France

15:00 Afternoon Refreshments

15:15 Lyophilisation Quality Improvement through Controlled Nucleation
 Depressurization and several variations of ice fog technique
 Natural variation in ice nucleation
 Benefits of controlled ice nucleation
 Maximizing quality for therapeutic proteins

Joseph Brower,
Technology Manager,
IMA LIFE
North America

16:00 End of Day One.

Day Two
08:30 Innovative analytical technologies for application available before, during and
after the freeze drying process
 Grouping of materials to prepare for the freeze-drying process
 Available technology for the freeze drying process
 Assessing the lyo products after the process

09:30 Ideas to use laser spectroscopy to control freeze drying cycles

 Current techniques to control freeze drying cycles
 Technical realization on the freeze dryer
 Available experiments for cycle control

10:15 Morning Refreshments

10:30 Assessing the Importance of quality by design in biopharmaceutical
Manufacturing
 Quality target product profile
 Quality risk management
 Process analytical technology
 Design of experiments

11:00 Undertaking Lyophilisation Process Design, Development and Scale-up

 Guidelines for freeze-drying process design and development
 General process design and scale-up challenges
 Freeze drying PAT
 Monitoring and Control of freeze drying processes

Dr. F. Jim,
Faculty of Veterinary science,
 University of Zimbabwe,
Zimbabwe
11:30 Formulation and process development of lyophilized orally disintegrating tablets
 Orally disintegrating tablets
 Lyophilisation; annealing; sublimation rate
 Thermal analysis and formation of intact tablets

13:00 Networking Lunch

14:00 Using Drying methods for vaccine design
 Formulation design and drying methods
 Formulation and lyophilisation of vaccines
 Dried vaccine formulations to improve on vaccine delivery
 Choice of formulation and drying methods

15:00 Afternoon Refreshments

15:15 Assessing the spray drying method in the face of freeze drying method
 Reviewing the two technics
 Methodology and application of each method
 Assessing the methods relationship to the industry as a whole
 Analysing the benefits of the two methods

16:00 End of Day Two

Number of Delegates Price International Delegates

Price per Delegate R8 999.00 [EXCL VAT] USD $ 1000 [they don’t pay vat]
3-4 Delegates (5% Discount)
5-9 Delegates (10% Discount)
10 Delegates (15% Discount)

TO REGISTER
Call Cindy Wellington on our booking Hotline +27 11 455 5184
Fax to Email 086 218 9367 / cindy@melrosetraining.co.za
In- House Training   Do you have 8 or more staff members that need training
  Do you want to train at your own venue and at a time
If you answered yes to any of these questions, that is convenient for you
then Melrose Training In House Training is the   Do you want to save up to 40% on public course
solution for your training needs. training costs

With in house training, you choose the timing and
location of the seminar, and can customise the
course content to meet your organisation's own
particular training needs.  In house ensures that
only your team is present at the course, ensuring
privacy which facilitates open and frank
discussions when training.
The 3 Benefits Of In-House Training
  Complete confidentiality in discussing your
organisation’s sensitive issues
  You can tailor the course content to suit your
particular needs
 No travel or Accommodation costs to pay for your staff
For a free quote on  In-House Training : You can contact
 Mujoka Habanyana on 0114555184 or
mujoka@melrosetraining.co.za
We can even create a bespoke one or two day
course on a training issue of your choice.