Microscopy & Microtechniques 45 Report on the Work of Dr Henning Gieseler in the Field of Pharmaceutical Freeze Drying
Dr Henning Gieseler leads the Freeze Drying Focus Group (FDFG) in the Division of Pharmaceutics at the Friedrich-Alexander University (FAU) Erlangen-Nuremberg. He started his research in this area in 2006 after first coming across freeze drying microscopy (FDM) during his post doc at the University of Connecticut in the USA where he used a Linkam FDSC196 stage. This led in the following years to a collaboration with Linkam on the development of innovative instrumentation dedicated to improve freeze drying characterisation methods.
The main research goal is to have a representative measure of the temperature point (or region) where the product starts to undergo structural (morphological) changes during primary drying of a freeze drying cycle. These changes can be visually detected, in form of ‘shrinkage’ or ‘collapse’. It is essentially the point where a (rigid) glassy system starts to flow (decrease in viscosity). This temperature point is specific for every single formulation in the world. Product defects or imperfections, such as collapse, are of regulatory concern and might impede pharmaceutical quality parameters. Conventional FDM allows the determination of the so called ‘onset of collapse temperature, Toc’. This measurement is performed using 2-3 µL of liquid placed between two glass cover slips. This experimental setup reflects a 2D measurement, i.e. on the pore size level. In other words, during freeze drying, the product would not show the expected level of collapse when exposed to the same process temperatures applied during the FDM measurement. In order to get a more complete understanding of product behaviour, a scale-up of the measurement was required to cover the full perfomance range and test product behaviour at larger volumes when in a commercial vial. This would then be a 3D experiment which would be more reflective of a typical freeze drying cycle. Together, these complementary techniques allow a better understanding of formulation in the frozen state and of the scale up factors (from 2µL to 5 mL) which allow improved process optimisation.
The work over the last two years has led to the production of Linkam’s Freeze Drying Vial System (FDVS). This development came in part from the excellent work of one of Dr Gieseler’s PhD students, Zixin Huang. Dr Gieseler comments on the collaboration: “Our work with Linkam has enabled the release of a cost-effective solution with a small footprint for freeze drying optimisation. We have also seen that Linkam’s new Optical DSC performs a complementary role in the process.”
44951pr@reply-direct.com
New Upright Microscope Range Features Smart Technology
Motic Scientifi c Instruments makes a step forward with its newest upright microscope range, the Panthera series. The world of microscopy is an experienced world of precise scientifi c instruments with huge applications within all fi elds. The Panthera microscope series is a smart combination of user-friendly and advanced technology that, combined with a simple operational method of connectivity to the world of scientifi c instruments, embodies accuracy and precision.
Motic’s Panthera microscope series not only has a new and original design, but it also features a patented rackless stage with a surprising never-seen-before sample holder, a coded LED nosepiece and a LED condenser that allow to automatise and simplify the user’s work. The new objectives with ultra-high contrast and very fl at Field of View, together with the new eyepieces, give bright, detailed and sharp images for new insights.
If there’s a word to defi ne the Panthera series, is Smart. Its most extraordinary feature, the new ImagingOnDevice System, offers endless options to work with digitised images, changing the conventional microscope concept by turning it into a complete digital microscopy workstation.
“In today’s daily life with the world at our fi ngertips, it is common to snap a picture, post it and share it with your social circle. Why not combine that? Why not take out the complexity of the scientifi c instrument by replacing it with simple-to-use connectivity? Why not make
things easier?” Sebastian Nunnendorf, Motic Scientifi c Instruments Product Developer said.
Remarkable incorporations in terms of new contrast methods, and a wide range of intermediate modules and specifi c optics, make the Panthera series diverse and fi t for all environments. A whole new array of possibilities especially created to cover all areas, from the educational fi eld, going through to the most advanced models for clinics, laboratories and up to applications for industrial and material sciences. The Panthera microscope series has been created to make workfl ow easier, with the intent of it not being just another work tool, but a fellow worker to trust in. Know more at
www.moticpanthera.com.
44182pr@reply-direct.com
Particle Analyser to Automatically Image Nanoparticles for Identifi cation Introduced Nano from global
For the fi rst time, new instrumentation featuring Nano-Flow™ particle imaging provides digital images of particles ranging in size from 300 nm to 10 µm. Using patented, oil immersion technology for enhanced optical resolution, the new FlowCam®
laboratory instrumentation manufacturer Fluid Imaging Technologies, Scarborough, ME automatically reveals protein agglomerates, silicon oil droplets, glass shards and other opaque, transparent and translucent sub-visible particles with the high resolution imagery needed for identifi cation. Particle analysers based on light obscuration, dynamic light scatter, Brownian motion or Coulter Principle are unable to image these particles and allow for their identifi cation.
Ideal for analytical scientists, biochemists, formulation scientists, lab managers and other biopharmaceutical professionals, the new FlowCam Nano was developed to fi nd, expose and identify nanoparticles in protein formulations and help track the progression of protein agglomerates from individual, proteinaceous particles into the larger aggregates that pose a threat to the safety, effi cacy, stability and longevity of parenteral bioformulations. In addition, the FlowCam Nano may serve as an invaluable companion to USP<788> compliance testing methods for particulate matter by documenting the presence and type of nano-scale particles, which may cause failed test results.
The FlowCam particle imaging and analysis family of instruments now encompasses six models engineered to analyse particles ranging from 300 nm to 5 mm in size. The FlowCam models automatically measure more than 40 different parameters in real-time from size, count and concentration to colour, grayscale and morphological characteristics such as circularity, elongation and fi bre curl.
For more information visit http://www.fl
uidimaging.com/nano.
44201pr@reply-direct.com
What’s in the next issue? Find out with a copy of our Media Information Pack.
WWW.LABMATE-ONLINE.COM
Contact our sales team for your copy.
sales@intlabmate.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52
