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Technology
OUR FOCUS
We’ve been helping couples and prospective parents with our human-derived gonadotropins.
Our speciality is in the fertility treatment space and we now make forays into the international market through our contract manufacturing services for leading global pharma giants to serve
the world market. Our portfolio in addition to gonadotropins also includes sex hormones and speciality probiotics.
EXPERTISE
We bring together a diverse set of domain expertise and experience. Our multi-domain knowledge base includes Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Analytical and Formulation Research & Development, Medical Affairs, Supply Chain Management, Engineering and Information Technology. 200+ we bring to the table an immense body of knowledge, experience and specialized skill set that keeps continuously growing. Our human capital is the collective talent that drives our growth in the niche space of infertility. More than 75% of our human resource capital is from bonafide science, biotech and pharmacy background.
WE ARE A DIVERSE TEAM WITH SUBSTANTIAL COLLECTIVE EXPERIENCE AND MULTI-DOMAIN SKILL SETS
OUR SCIENTIFIC RIGOUR VETTED BY QUALITY.
Quality Assurance and Control
Our Quality Assurance takes a stringent approach to ensuring product quality meeting the required standards, both domestic and international. The process of Assurance entails establishing quality objectives, identifying and implementing quality control measures, and continuously monitoring and improving the quality of the product or service.
Our Quality Control (QC) team, follows the cycle without deviation to verify that a product meets the specified quality standards. QC identifies and analyses defects or errors, and then implements corrective measures to prevent the recurrence of such defects or deviations. QA and QC working in synchrony let us maintain greater control over their quality management processes and product quality, resulting in consistent customer satisfaction.
R&D
ANALYTICAL - CHARACTERIZATION STUDIES
- Our Gonadotropins are well characterized with bioanalytical techniques and exhibit structural equivalence with Innovator products.
- Primary structure is established by intact mass and peptide mapping. The secondary and tertiary structure is probed by circular dichroism measurements.
- Purity size and aggregate profile is established by SE-HPLC and SDS-PAGE. Charge based isoform profiling is characterized by cIEF.
- Subunit analysis and product related impurities are established by reverse phase HPLC and reducing SDS-PAGE.
- Overall the structure, size, intact mass, purity and post translational modifications of Sanzyme Gonadotropins were similar when compared to Innovator products.
ANALYTICAL - CHARACTERIZATION STUDIES
- Our Gonadotropins are well characterized with bioanalytical techniques and exhibit structural equivalence with Innovator products.
- Primary structure is established by intact mass and peptide mapping. The secondary and tertiary structure is probed by circular dichroism measurements.
- Purity size and aggregate profile is established by SE-HPLC and SDS-PAGE. Charge based isoform profiling is characterized by cIEF.
- Subunit analysis and product related impurities are established by reverse phase HPLC and reducing SDS-PAGE.
- Overall the structure, size, intact mass, purity and post translational modifications of Sanzyme Gonadotropins were similar when compared to Innovator products.
PRECLINICAL STUDIES
- Our Gonadotropins namely HMG, FSH and HCG have been evaluated pre-clinically for toxicity viz Single dose Toxicity and Repeat Dose Toxicity studies using rodent species.
- Pre-clinical Toxicity studies were conducted according to the OECD Principles of the Good Laboratory Practice (GLP).
- The Pre-Clinical study results reaffirm the safe tolerable dose in rodents and paved the way for use in humans and support human clinical trials.
PRECLINICAL STUDIES
- Our Gonadotropins namely HMG, FSH and HCG have been evaluated pre-clinically for toxicity viz Single dose Toxicity and Repeat Dose Toxicity studies using rodent species.
- Pre-clinical Toxicity studies were conducted according to the OECD Principles of the Good Laboratory Practice (GLP).
- The Pre-Clinical study results reaffirm the safe tolerable dose in rodents and paved the way for use in humans and support human clinical trials.
CONFIRMATORY CLINICAL STUDY PHASE 3
- Our Gonadotropins namely HMG, FSH and hCG have been evaluated clinically in comparison with innovator products.
- Clinical studies were conducted in accordance with the ICH-GCP (Good Clinical Practice) Guidelines and were initiated after obtaining the necessary Regulatory and Ethics Committee approvals.
- Clinical Studies are performed in collaboration with an International CRO and are in line with the global standards of regulatory requirement.
- The studies are registered prospectively with the CTRI and the results are promising in terms of “Number of Oocytes retrieved” in women undergoing In Vitro Fertilization and were proven to be Non-Inferior as compared to the Innovator products.
- Can be used safely in women undergoing ART to achieve the desired efficacy in terms of successful pregnancy.
CONFIRMATORY CLINICAL STUDY PHASE 3
- Our Gonadotropins namely HMG, FSH and hCG have been evaluated clinically in comparison with innovator products.
- Clinical studies were conducted in accordance with the ICH-GCP (Good Clinical Practice) Guidelines and were initiated after obtaining the necessary Regulatory and Ethics Committee approvals.
- Clinical Studies are performed in collaboration with an International CRO and are in line with the global standards of regulatory requirement.
- The studies are registered prospectively with the CTRI and the results are promising in terms of “Number of Oocytes retrieved” in women undergoing In Vitro Fertilization and were proven to be Non-Inferior as compared to the Innovator products.
- Can be used safely in women undergoing ART to achieve the desired efficacy in terms of successful pregnancy.
Since 1969, when we entered into a Joint Venture with Sankyo (now Daiichi-Sankyo) to make gonadotropins to export to Japan, we’ve been at the forefront of biological hormones, and today we have the necessary technological foundation to do path breaking work.