P1-0340 — Annual report 2011
1.
Pharmaceutical composition comprising an active principal and sulphobetaine

In 2011 U.S. patent was granted for a formulation containing sulfobetaine to prevent aggregation. Sulfobetains play protective role, which is usually achieved by addition of low concentrations of detergents (e.g., Tween).

F.32 International patent

COBISS.SI-ID: 1490268
2.
Preparation and characterization of Met-G-CSF dimers and their pegylated conjugates

Completed PhD study about design and characterization of various hG-CSF dimers and their PEGiyated variants for potential use in therapy with co-mentorship by the member of program group. PhD thesis was completely prepared within Lek d.d. After successful completion candidate was employed by Lek d.d. and obtained permanent contract.

D.09 Tutoring for postgraduate students

COBISS.SI-ID: 255268608
3.
Successful initial clinical trials for originator's molecule, where members of program group contributed to its development

PEGylated originator’s biopharmaceutical, which PEGylated form was developed in Menges, where we also performed GMP manufacturing for Phase I clinical trials, in 2011 successfully passed the first clinical trials and showed even better results than it was expected, both in terms of efficacy as well as the half time extension due to PEGylation. In 2011 program group members were involved in further development activities and additional GMP manufacturing campaign in Mengeš to supply the clinical trial phase I / II.

F.06 Development of a new product