S.P. Mandali's Institute for Advanced Training and Research in Interdisciplinary Sciences (Therapeutic Drug Monitoring Laboratory) is managed by Shikshana Prasaraka Mandali, Pune which is a registered trust involved in education. The trust manages about forty educational institutions in Maharashtra and is involved in providing pre-primary, primary, secondary and teacher's training, it also manages colleges of higher education (till Ph.D.) in fields of Arts, Science, Commerce and Management. The organization is affiliated to the University of Mumbai for research. The organization works as a private body managed by a registered trust which has its office at Pune. The trustees form a managing committee for the management of the administrative affairs.
The S. P. Mandali's as Institute for Advanced Research and Training in Interdisciplinary Sciences (IATRIS) is also identified as Therapeutic Drug Monitoring Laboratory (TDML) was established in 1986 and since then the center has not only been working in close association with the India pharma but it also has been providing advanced training in specialized areas of instrumental analysis, drug research and R&D services in Cosmaceutical and Neutraceuticai since last thirty one years. The institute is affiliated with the University of Mumbai (institutional Code - 685) and is a recognized research centre in Chemistry.
The institute is also recognized by the University of Pune for Ph.D. in Chemistry. The institute houses sophisticated instruments and associated computational infrastructure for carrying out high-end bio-anaiytical work. Since its inception the Organization has been working in close association with the Indian Pharma, Cosmaceutical and Nutraceutical industries.
Major activities of IATRIS
IATRIS undertakes around 30 R & D studies annually for various Indian health care and pharma industries. IATRIS has gained extensive expertise from these activities which has been conducted since more than 33 years. All these projects are ably supported by the research acumen of the institution. The knowledge gained has resulted in IATRIS undertaking research and development projects for innovating or improving the existing formulations and FMCG products to meet the quality requirements of the industry. IATRIS has till date undertaken several R&D projects funded by the Government of India and some of them have led to patent applications and technology transfers. Some of the products that were developed with expertise and work carried out by IATRIS are Mediker antilice oil, Parachute harifall therapy, No marks cream, Dettol antimicrobial soap, anti-perspirant spray for Aditya Birla Group etc. In the therapeutic drugs sector studies conducted at IATRIS has enabled marketing of some important generic drug formulations especially fixed dose combinations for treatment of diabetes, cardiovascular problems , inflammation, hyperacidity, hypertension and psychosis.
IATRIS also provides R & D support to industries especially small and medium size companies for ensuring quality of their raw materials, inprocess materials and finished products. These services are in form of development of sensitive bioanalytical techniques, standardizing quality control parameters and evaluating efficacy of finished products. IATRIS has the distinction of being one of the major CROs to undertake bioanalytical evaluation of chirally pure drug molecules and their metabolites. Some of the methods developed by the institution has been published in international peer reviewed journals.
Currently, IATRIS enjoys the distinction of being probably the only CRO in India which can successfully undertake sophisticated bioanalytical studies on chirally pure compounds on LC-MS/MS. The institution can boast of above 90 research publications in peer reviewed scientific journals. Some of the methods developed at the institute have been published in regulatory monographs issued by the Government of India entitled The Ayurvedic Pharmacopoeia of India.
IATRIS also conducts training programmes which are designed to develop instrumentation skills in post graduate students, teachers and industry personnel. The institute is affiliated to the University of Mumbai and is a recognized center for doctoral research. Customized training programs are also designed and organized to meet specific needs of the pharma industry.
S.P. Mandali's Institute for Advanced Training and Research in Interdisciplinary Research, however, has been working closely with the Indian Pharma industry for the last more than twenty eight years (since 1986) in research and development of new drug molecules especially the generic versions of modern drug molecules. Due to this collaboration, more than 50 new generic molecules have been marketed in India. These successful collaborations have been with Cipla Ltd, Intas Pharmaceuticals, Emcure Pharmaceuticals, Modi Mundi Pharma, U.S. Vitamins, Ajanta Pharma, Serdia Chemicals, Dabur Research, Marico Industries, Hindustan Unilever to name a few. The institution is one of the first centers in India to commence BA/BE studies for generic drugs. Since the institution started its activity in 1986 more than 500 BA/BE studies have been completed at the center till 2015.
Herbal Drugs The Institutions extends its work experience in bioanalysis for evaluating bioavailability of herbal drugs and effect of bioenhancers on modern drugs molecules. The Institute has carried out some pioneering work on curcumin to understand its bioavailability for oral cavity.
Training ProgrammeThe sophisticated instruments at the institution are used in various training programmes conducted for post graduate students, research students, teachers and the industry personnel. The training programmes are generally customized to suit the needs of the trainees. The training programmes are conducted by the involvement of all divisions of the institution and with the able support of the great repository of knowledge available with the institutional library. In addition to the training the facilities of the institution is made available to researchers and industry personnel for carrying out specific projects. The extensive experience of the institute in bioanalysis is made available to research students , post graduate students and teachers of Mumbai university and other universities in India in form of R & D support and training in various forms.
IATRIS also conducts training programmes which are designed to develop instrumentation skills in post graduate students, teachers and industry personnel. The institute is affiliated to the University of Mumbai and is a recognized center for doctoral research. Customized training programs are also designed and organized to meet specific needs of the pharma industry.
S.P. Mandali's Institute for Advanced Training and Research in Interdisciplinary Research, however, has been working closely with the Indian Pharma industry for the last more than twenty eight years (since 1986) in research and development of new drug molecules especially the generic versions of modern drug molecules. Due to this collaboration, more than 50 new generic molecules have been marketed in India. These successful collaborations have been with Cipla Ltd, Intas Pharmaceuticals, Emcure Pharmaceuticals, Modi Mundi Pharma, U.S. Vitamins, Ajanta Pharma, Serdia Chemicals, Dabur Research, Marico Industries, Hindustan Unilever to name a few. The institution is one of the first centers in India to commence BA/BE studies for generic drugs. Since the institution started its activity in 1986 more than 500 BA/BE studies have been completed at the center till 2015.
Herbal Drugs
The Institutions extends its work experience in bioanalysis for evaluating bioavailability of herbal drugs and effect of bioenhancers on modern drugs molecules. The Institute has carried out some pioneering work on curcumin to understand its bioavailability for oral cavity.
Training ProgrammeThe sophisticated instruments at the institution are used in various training programmes conducted for post graduate students, research students, teachers and the industry personnel. The training programmes are generally customized to suit the needs of the trainees. The training programmes are conducted by the involvement of all divisions of the institution and with the able support of the great repository of knowledge available with the institutional library. In addition to the training the facilities of the institution is made available to researchers and industry personnel for carrying out specific projects. The extensive experience of the institute in bioanalysis is made available to research students , post graduate students and teachers of Mumbai university and other universities in India in form of R & D support and training in various forms.Sample AnalysisThe institute also provides specific bioanalysis services including developing new methods for industries. These include analysis of samples for quality evaluation and transfer of new methods to the industry.
Ethics
All clinical trials undertaken by the institute are reviewed and approved by an Institutional Ethics Committee registered with Drug Controller General (India) since 2013 which ensures that the study is carried out as per scientific and ethical norms. The Institutional Ethics Committee is composed of 13 members and 01 member secretary. The members comprise of experts like clinical pharmacologists, consulting physicians, social workers, educationists, legal experts and individuals of known standing as the members of the committee. The committee also ensures the general well-being of volunteers during the conduct of a study.
Consultancy
The institute also extends various consultancy work to different industries especially the Indian pharmaceutical sector.
Shikshana Parasraka Mandali's Institute for Advanced Training and Research in Interdisciplinary Sciences (IATRIS), Sion, Mumbai has been carrying out such analysis since more than a decade. The services provided by the Institute have helped many clinicians treating neuro-muscular disorders to support and manage their patients better. The services are being used by patients from all over India. Being an Institute managed by an Educational Trust, the tests are provided at reasonable costs with special concession extended to patients from Municipal and Government hospitals. Over these years, the Institute has built a database of patients with Muscular Dystrophy especially, from the western region of our country. The Institute wishes to consolidate the services rendered by upgrading the Institutional technical infrastructure so that contemporary more advanced genetic analysis protocols can be implemented.
Past experience of team at department of molecular biology-IATRIS, Sion, Mumbai
Studies on dmd/bmd
Amongst the most frequent myopathies in all populations are the duchenne /becker muscular dystrophies (dmd/bmd). The distribution of deletions within the dystrophin gene of dmd/bmd patients has been studied, using multiplex pcr techniques and recently with mlpa. These studies are carried out in very few laboratories in india. A total of approximately over 1150 samples of clinically suspected cases of dmd/bmd have been analyzed by multiplex pcr methods, by our group over a period of ten years. Approximately 71% of patients showed deletions of one or more exons. 29% of patients did not show any deletions in the 32 exons covered inspite of showing strong clinical features suggestive of dmd/bmd. Some of the patients showing no deletions were taken clinical features suggestive of dmd/bmd. Some of the patients showing no deletions were taken for mlpa (multiplex ligation-dependent probe amplification). Mlpa (multiplex ligation-dependent probe amplification) have revived interest in the detection of deletions and duplications, and carrier status in females primarily due to the simplicity and flexibility of this methodology. In mlpa, probes (not dna) added to the samples are amplified and quantified. Hence, is considered as the method of choice for initial dna analysis. In our studies, covering western india no apparent correlation was seen between the size and location of the deletion and the severity of the disorder. Further deletion studies have been undertaken to analyze translational frame shift hypothesis and its significance in the progression of the disease (dastur et.al, 2008).
SMA StudiesA total of 380 samples of clinically suspected cases of SMA have been analyzed by PCR-RFLP and mPCR methods, by our group over a period of eight years. Consolidated results of all the samples including detail clinical details are being maintained for research and publication.