Formulation & CMC Development Services
VTL's Formulation & CMC development services department focuses on development of topical products using novel drug delivery approaches. Formulation specific literature research and prior-art search are the prerequisites to start of any project. Pre-formulation studies, API modification studies, formulation improvement trials, process optimization, physicochemical & in vitro evaluation, packaging, stability studies, sensory evaluation, pilot scale-up, bulk manufacturing of shortlisted formulations are the major activities carried out by the department. VTL employs state-of-the-art facilities and technologies along with a calibrated approach towards formulation development of pre-clinical and clinical stage products to deliver the best quality products and to help the products reach the market in a much shorter time-frame.
In order to expedite the overall product development process and have access to product specific facilities, some of the activities are conducted in outside facilities in collaboration with partners.
Analytical Development Services
Analytical Development services plays a pivotal role in setting the product standards by ensuring the best quality for the drug substance and the drug product. We remain committed to the highest levels of quality and ensure that our infrastructure and services continue to meet the exemplary standards that are expected of a global pharmaceutical company. The department is equipped with state-of-art facilities and equipment such as analytical HPLCs with PDA detectors, and UV-Vis spectrophotometer. The department undertakes development of analytical methods, validation & documentation for new chemical entities, generic drugs and intermediate and finished drug products. It also performs measurement of bioactive content for new chemical entities, drug derivatives & drug products; related substance profiling and other physico-chemical parameters as per specifications. The department also determines stability of drug actives and drug products & recommends storage conditions. It also works on extensive surveying of analytical literature, technology transfer including documentation into other sites, implementing stability studies as per ICH guidelines and enabling and overseeing company quality systems.
Development of drug resistance brings new challenges in antimicrobial chemotherapy for development of new drugs. This brings new opportunities for designing and engineering of new chemical entities or modification of existing molecules to combat this drug resistance. Towards this end, the Chemistry department at VTL brings together infrastructure and competence in synthetic organic chemistry, medicinal chemistry, polymer chemistry and nanotechnology for drug design. It has core competency in conjugation chemistry directed at building new antimicrobial agents with minimum synthetic steps, and using organism-assisted cleavable linkers for different lipids and polymers. Molecular docking studies are also being used as an important tool to design and screen effective antimicrobial agent that would have better binding at the target sites than existing antimicrobial agents.
Foundation of VTI's technology platform is based on the scientific evidence on why and how skin microbes develop their habitats in different skin layers. Biology and Pre-clinical Scientists at VTL design every approach of experimentation to clearly establish the main goals of drug development, a better and safer therapy. To identify superior drug candidates, VTLs Biologists initially pursue in–depth research to dissect the patho-physiological basis of the diseases utilizing microbiology, electron microscopy, and fluorescence microscopy based assay methods. Often the functional evidence also gets corroborated by genomic analysis for the presence of relevant signatures in the pathogens. Once the patho-physiological basis is sufficiently teased out in vitro, candidate drug molecules are compared for their inhibitory effects. Sophisticated computational tools are used to predict the optimal structures of potential drug candidates to enhance molecular interactions. Selected candidates of the parent Company VTI are then further evaluated in relevant animal models for their potential clinical effectiveness. Once strong evidence in favour of clinical efficacy of candidate molecules is generated, VTL's scientists test them for their bio-availability and safety profile in different animal models for eventual regulatory approval.
Quality Assurance (QA) plays a critical role in the in-house development of products, vendor qualification and release of products manufactured at third party GMP certified vendor. QA team works in tandem with all departments to up keep the standards set by international standard like ISO 9001. QA is responsible for preparing, approving and monitoring the implementation of key documents (Quality Policy, Quality Manual, etc.). QA is the custodian of SOPs which are prepared to implement world class standard practices in all services rendered by VTL.
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