Lyophilization: Process development from lab to production - Kncv

“Freeze drying and spray drying,
industrial perspective”
Schedule
Wednesday, May 23rd, 2012
Congress Centre “Regardz De Eenhoorn”, Amersfoort
Organized by the Working Party on Downstream Processing of
the Dutch Biotechnological Society (NBV)
18:00-19:00 Registration, luxury sandwiches, soup and coffee
19:00-19:45 Lyophilization: Process development from lab to production
Jack Nijholt, MSD Animal Health
19:45-21:00 Spray drying, a mild drying technique
David Hollestelle (NIZO) and Marc Vorage, (Avebe)
20:45-22:00 Closing and drinks
This session is chaired by Maarten Pennings and Jeroen den Hollander

Lyophilization: Process development from lab to
production
Jack Nijholt, MSD Animal Health
Freeze drying, or lyophilization, is a technique that is used at MSD Animal Health to stabilize live
vaccines. Although the technology is time consuming and expensive it is used for a significant
number of products, not only at MSD Animal Health but across the pharmaceutical industry.
The presentation will include a case study of how the lyophilization cycle time of a product has been
reduced, from the start of the project until implementation of the developed lyophilization cycle in
the production environment. Furthermore, recent developments in freeze drying technology will be
highlighted and evaluated against the pressure of producing more product in the same time frame.

Spray drying, a mild drying technique
Ir. David Hollestelle (NIZO) and
Ir Marc Vorage, (Avebe)
Drying of heat sensitive products with hot air seems to be a paradox. However by spray drying in a co-current
mode it is possible to limit the heat-exposure of the product and thus retain (most) of its functional properties. The
result of heat exposure to sensitive products can be for example: denaturation of proteins, inactivation of biomass
and color formation by Maillard reactions.
Spray drying is an energy intensive process. As a rule of thumb only half of the energy used for heating the
incoming air is used for water evaporation. The other half is lost by the (hot) vent gasses of the dryer. Polymer
heat exchangers are under development to recover part of the energy from the vent-gasses to heat-up the “cold”
incoming air.
Despite the energy consumption, spray drying is a proven and matured technology that is capable of producing
powder with the desired particle size, moist content, bulk density and many other parameters. In case of a good
design and adequate air-filtration, microbial hygiene can be ensured.
This presentation will explain the technology of atomization of droplets, drying and recovery of product. The typical
characteristics of spray-dried powder will be given and how these can be influenced by changing the process
conditions. Some examples and future developments will be presented. Finally there is time for discussion.
.

Information
The mini-symposium will be held in congress center “Regardz Eenhoorn” in Amersfoort. A
route description (by car and public transportation) can be found on the web site of the
congress center (www.regardz.nl).
The mini symposium is free of charge for members of the NBV as well as for BSc and MSc
students, if registered before May 14 th , 2012. When registered before May 14 th , the fee for
other attendants is €25,00. For registration after May 14 th , the fee is €30,00. Please provide at
the meeting in cash and in exact money.
For more information about this mini-symposium, please contact the organizers:
Maarten Pennings and Jeroen den Hollander via email: nbv-pz@kncv.nl
Registration
Register for this mini symposium has to be done via the registration form on the website
www.nbv-pz.nl.
Working Party on Downstream Processing
The Working Party on Downstream Processing is part of the Dutch Biotechnological Society
(NBV). Its objectives are:
• To keep the members of the working party informed on international developments in the area of
recovery and purification of biological products;
• To enable members to exchange ideas and discuss developments with other scientists in this
area.
This is done a.o. by maintaining a web-site (www.nbv-pz.nl) and organizing events such as
symposia, courses and lectures.
For additional information on the working party, please visit the web-site or contact any of the
members:
Jeroen den Hollander (jeroen.hollander-den@dsm.com) Marcel Ottens (m.ottens@tnw.tudelft.nl)
Reinoud Noordman (reinoud.noordman@heineken.com) Emile van de Sandt (emile.sandt-van-de@dsm.com)
\Marc Bisschops ( .bisschops@bataviabioservices.com) Michel Eppink ( michel.eppink@synthon.nl
Maarten Pennings (m.pennings@bataviabioservices.com)