Transcript Institute of Biotechnology and Antibiotics

Institute of Biotechnology and
Antibiotics (IBA)
Presented by Małgorzata Kęsik
Assistant Professor at IBA
Institute of Biotechnology and
Antibiotics (IBA)
• Is a State research and development centre
established in 1985 by the Minister of Industry.
• Its activity is associated with health care and
pharmaceutical industry.
• Employs 125 people, including 26 scientists.
The IBA Bioton Group
Institute of Biotechnology and Antibiotics has been
taken over and developed by Bioton.
Currently IBA and Bioton forme IBA-BIOTON
Group.
IBA-BIOTON Group is a Polish leading
pharmaceutical producer.
The research work at IBA
focuses on:
• methods of synthesizing new antibiotics,
• selection of highly effective strains of
microorganisms for the production of antibiotics,
• the improvement of antibiotic biosynthesis
processes,
• the study of mechanisms of transmitting
antibiotic-resistant genes in bacteria,
• development of new preparations for diagnosis
based on monoclonal antibodies.
The research work at IBA
focuses on (2):
• genetic engineering of new gene expression
systems,
• genome diagnostics,
• manufacturing of biologically active high purity
compounds with protein structure (e.g.:
recombinant human insulin, growth hormone and
interferon)
Recombinant
human insulin
 2000-2005: Completion of a long-term team
project
on
recombinant
human
insulin
manufacturing technology.
Biosynthetic human insulin solution, isophane
biosynthetic human insulin and its mixtures (17
pharmaceutical forms in total) were authorised
for marketing in Poland and implemented in
production by the Bioton company under the
Gensulin trade name.
IBA manufactures three
important antineoplastic
medications:
• Biorubina® (doxorubicin) - anthracycline antibiotic
used in solid tumour therapy haemopoietic and
lymphatic sarcomas and neoplasms.
• Bioepicyna® (epirubicin) - anthracycline antibiotic
used in various neoplasms
• Biodribin® (cladribine) – deoxyadenosine
nucleoside derivative, used in hairy cell
leukaemia, chronic lymphocytic leukaemia and
non-Hodgkin lymphoma.
International cooperation
Participation in international MolCoNet project,
financed by the EU (coordinated by Milan
University).
The project is to share experiences in utilisation
of logical operations with DNA.
Project participants: institutes and universities
from Austria, France, Spain, the Netherlands,
Moldova, Rumania, Great Britain and Italy.
Department of
Bioengineering
•
•
•
research on plasmids, aimed at producing own
high-efficiency protein expression systems,
research on genome’s mobile elements and
integrons in drug resistance development in
bacteria,
research aimed at recombinant viral antigen
production and application as oral subunit
vaccines
Offer – Genetic Engineering
• Construction of Escherichia coli working strains
producing specific protein or peptide medications
based on own expression or other vectors
patented by IBA.
• Working strain stability testing.
• Strain stability or protein production enhancement
by implementing genetic changes in vectors.
• Periodic control of protein coding sequence in the
expression vector as required by the Good
Laboratory Practice principles.
Offer – Genetic Engineering (2)
• Development of separate analytical methods for
each medicinal product, including quantitative
determination of contamination with host protein,
plasmid and genome DNA required by the
European Medicines Agency, determination or
development of the ELISA test and production of
monoclonal antibodies used in the test.
• Biological activity test of the protein medications
in cell cultures.
Offer – Genetic Engineering (3):
• Development of immunological ELISA tests to
determine other impurities in tested medications,
e.g. residual enzymes used in production.
• Orders for developing purification methods for
specific proteins made by working E. coli strains
with respect to limitations associated with
process scale-up from beaker to industrial scale.
Thank you for your attention
Ph.D. Małgorzata Kęsik
Institute of Biotechnology and Antibiotics
[email protected]