Our research group is focused on therapeutic protein and peptide formulation and delivery.
The vast majority of these drugs is applied parenterally, as a consequence we are working on pertaining aspects of parenteral dosage forms including aseptic production technologies, drying technologies (like freeze drying, vacuum-drying, evaporative drying, etc.) and primary packaging materials.
is a major concern when dealing with protein drugs; therefore we are
interested in every aspect of protein stability, especially physical
stability issues (like aggregation and precipitation).
Novel approaches to speed up the selection of stable formulations are studied (e.g. Non-isothermal stability studies, microcalorimetric and spectroscopic techniques).
Parenteral depots to deliver proteins systemically or locally over a longer period of time are another focus of our work. Having used PLGAs and ABA-triblockcopolymers together with other research groups, we are now concentrating on alternatives like lipid systems and in situ forming depots. Optimisation of such systems and on the other hand the exploration of detailed release mechanisms are the subjects of our recent work.
For all these tasks, state of the art analytics have to be applied. Besides using analytical protocols from the literature we try to explore the potential of selected new analytical methods, e.g. like AFFFF and others.
development of highly concentrated antibody formulations is a hot topic
all over the entire biotech industry. We have therefore included a project
on protein crystallization into our portfolio.
Finally viruses like particles are studies with respect to stability during long term storage.
colloidal materials bridge our protein drug focus with a second topic
of our research: colloidal drug carriers. Parenteral Nanosuspensions
for sparingly soluble drugs; manufacturing technologies for large scale
production and stabilization of liposomes; new formulations with cationized
nanocarriers for “soft targeting” shall be mentioned as
the actual research projects in this area.
Dr. Coesters research team, although for formal reasons under my supervision is independently working on gelatin nanoparticles in a wide variety of uses including gene therapy, immunostimulation, cancer vaccination, liver targeting etc.
new joint project is located between all of these approaches and deals
with gas filled microbubbles. Although by size (~ 1-5 µm) no longer
“colloidal” such ultrasound activated phospholipids carriers
can be physically targeted, i.e. activated by ultrasound in the living
body to deliver DNA or conventional drugs into surrounding cells.
Our team cooperates largely with the researching pharmaceutical industry including small biotech groups as well as with large multinational companies. Beside others we have cooperations with Abbott, BI, Roche, Merck, Cytos, and Medigene. University cooperations start within the department for pharmacy at the LMU and extend to our partner universities at Halle, Berlin, Bonn, Lille, Denver, Heidelberg, Tromsø, Copenhagen, etc.
We are always open for cooperations. Please feel free to contact us directly, preferably by email under Gerhard.Winter@cup.uni-muenchen.de.
Due to our excellent technical infrastructure we can offer to assist you with analytical and formulation problems within the formal frame set forth by the regulations for our university. Please feel free to contact us with respect to such service tasks under the email address listed above.
Finally we have some very special infrastructure setup in our institute: Due to the focus on parenteral dosage forms and fostered by the more than 20 years of cumulated experience in industry and clinical supplies manufacturing of our leading personnel we have built a complete GMP-sterile facility You will find more details at this link. Briefly, it is a small but fully equipped unit enabling us to manufacture vials filled with solutions or lyophilized product under full aseptic conditions up to batch sizes of about 2000 units. A class A isolator allows furthermore to manufacture non standard research type formulations like implants in small numbers, again fully aseptically.