Ctro Inmunologia Molecular monoclon at infomed.sld.cu
Tue Mar 8 00:14:32 EST 1994

production institution with more than 60 scientists and engineers, devoted
to basic research and product development in the fields of monoclonal
antibodies and cancer vaccines.
Molecular immunology is just emerging and opening enormous new
possibilities of applications. This is because it is the uncoding of an
information system.
Somewhere in the sixties, molecular genetics started to discover the
organization and functioning of the information pieces stored in DNA,
and the relationships between this information and the biological
experiences of the species. Nowadays a second information system (the immune
system) is being well understood and this system, beyond the biological
experience of the species, stores the individual experience coded on a
repertoire of protein receptors. When one realizes that the potential diversity
of only the antibody repertoire is calculated to be near 10X30 it is clear that
we have barely started to take the first steps inside the possibilities of
such an eficient molecule invention machinery.
Molecular Immunology is a field of interphases. It is a mixture of Immunology,
Molecular Biology, Cell Culture, Fermentation, Pharmacology, Clinical expertise and so
on. Success depends not only on how in depth one can go in any of these
disciplines, but also on how to mix knowledge across disciplines borders.
That is what CIM is doing.
Biotechnology was identified as a national priority by the cuban
government early in the eighiies . Big investments have been
performed to create new scientific institutions, scale up facilities,
nation wide laboratory networks and commercial enterprises.This
emerging Biotechnology industry profited the enormous investment
previously made in education, scientific research and public health.
The most well known investment of the nascent biotechnology industry is what
is called The West Havana Scientific Pole: it is a zone of the town where more
than 20 scientific centers and production facilhies are located near each other.
One of them is The Center of Molecular Immunology.
CIM is located near The Finlay Institute for vaccine production, The Center of
Genetic Engineering and Biotechnology, Center of Medical and Surgical Research,
The Center of Immunoassay, The Faculty of Pharmaceutical Sciences, the Faculty
of Medicine, among others.
CIM has promoted the creation of monoclonal antibody laboratories inside the
Faculties of Medicine in 13 out of 14 provinces of the country. This is a nation
wide network which increases research capahilities and also guarantees practical
uses of MAb based products.
The Center of Molecular Immunology is a new ins~tution, that
gathers an experienced scientific staff in the field of monoclonal antibodies.
The senior staff of CIM is a group of scientists which started working in the
seventies in the experimental research division
of the National Institute of Oncology and Radiobiology ()INOR) . At
that time the control of cell proliferation, immunology of lyrnphomas and
screening of new immunomodulators were the main fields of research . They also
camed out research on horrnone receptors and growth factors in cancer. World on
monoclonal antibodies (MAbs started in 1981. One of the first INOR MAbs, an
anti T lymphocyte (CD6 antibody) was used in vivo for the treatment of lymphoma
akeady in 1984.
In the second half of the eighties research on monoclonal antibodies becarne one of the
Institute's priorities.
A new clinical trial using anti CD3 antibody as immunosuppressor in organ
transplantation started in 1987. The product was registered in Cuba in 1989.
At that time, space and equipment limitations prevented further scaling-up MAb
Therefore, in 1990, CIM was decided to be created gathering the majority of the previous
INOR experimental research staff and also hiring other scientists and engineers with
experience in Fermentation, Scale up production and Quality Control Programs.
Building of new facilities started in 1991.
The permanent staff of CIM consists 62 scientists and engineers,
directly involved in research and production. Most of them have
received training in Europe, mainly in Sweden, France, Germany,
U.K., and Holland.
The 29 scientists that conform the core group of this staff have been working
together for more than 10 years.
There has been an effort to keep the staff highly heterogeneous in professional
Medical Doctors..6
Veterinary Doctors..2
Managing positions are currently occupied by:
       Dr. Agustin Lage, Ph.D.
       Vice-Director of Research & Development:
       Dr. Rolando Perez, Ph.D.
       Vice-Director of Production:
       Eng. Joaqu!n Vill n, Ph.D.
       Quality Assurance Dept.:
       Dr. Teresita Rodriguez, Ph.D.
 The new facility of CIM is a 12 000 sqm building. The ground floor
 was built according to the principle of box into box. The core units
are the cell culture, fermentation and purification areas. They are
surrounded by a clean hall which cornmunicates through air locks with
peripheric laboratories for research diagnostic production and quality control
department. The second floor is for technical services and administration.
A system for filtered air at 9 diferent pressure levels guarantees class 10 000
and class 100 000 in 560 sqm areas respectively. Cleanest operations are performed
in class 100 stations inside class 10 000 rooms.
The building is supplied by 5 water loops of different qualities from normal
sanitary water up to "water for injection". Gas, waste treatmentt and "cleaning
in place" services are also provided.
Up stream production flows through three paralell ways: Mouse ascites, hollow
fiber bioreactors and stirred tank fermenters.
Down strearn purification consises of concentrative filtration followed by different
chromatographic steps  (i.e.ion exchange, affinity)
A computer network connects all units for collection and processing of production
data, and scientific information.
The facility allows to produce Monoclonal Antibodies up to Kilogram levels and to
handle more than 100 cell strains. It has been built according to current GMP guidelines
for manufacturing products intended for human use.
There are three levels of activity according to development stage of
products and results:
. mature product research
y Developing products
y Basic research.
Mature products are those with enough evaluation to be given to other Institutions.
They currently are:
y a panel of monoclonal antibodies for immunophenotyping of leukocyte subpopulations.
y a panel of monoclonal antibodies for tumor diagnosis.
y a panel of monoclonal antibodies for research
y ELISA systems for carcinoembryonic antigen determination in serum and Hb detection in
y purified gangliosides
y a monoclonal antibody for intravenous application as an irnmunosuppresor, in
the prevention and treatment of rejection crisis in organ transplantation.
Several scientific and medical instilutions participate in research projects for
further evaluation of usefulness of these products. Participation of new
institutions is wellcome.
Developing products are in turn at different levels of preclinical and clinical evaluation
and they include:
y Two new monoclonal antibodies for the treatment of Iymphomas and epidermoid
y Three new radioactive monoclonal antibodies for tumor imaging.
y new tumor marker Elisa systems.
y new monoclonal antibodies for immunohistochemistry.
Basic research proJects concentrate in the idea of breaking tolerance to self antigens
expressed in malignant tumors.
Gangliosides and Epidermal Growth Factor receptor are the two main models. New
antiidiotypic antibodies are also being investigated.
CIM actively promotes international cooperation. Science today
requires not only intelligent production of new knowledge but also
intelligent "recombination" of the existing one. As in gene evolution,
"recombination"  is a source of new traits that is as important as new
information. Several different cooperation modalities can be considered:
y joint research projects.
y cooperation in the generation of a new hybridoma
y cooperation in scaling up the production of an existing hybridoma
y  joint development of a new MAb based product
y research cooperation in some of the CIM products
y joint chnical trials
The reader of this brochure has now enough information to asses if his Institution has
areas of overlapping interests and if a cooperation meeting is worth to be promoted.
Center of Molecular immunology.
PO.BOX: 16040. Havana 11600, CUBA.
Fax 53-7-33 35 09
E.Mail: monoclon at infomed.sld.cu
With US the best way is electronic mail!!!!!!

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