Pharmaceutical contract manufacturing in India has grown rapidly in the recent past. Today, India has the maximum number of FDA-approved manufacturing facilities outside the USA. This has made it a global leader in the field of generic drugs, accounting for 20 percent of the exports. However, the growth has been accompanied by challenges such as intensifying regulation. Global regulatory authorities such as the FDA and EMA have made their rules more stringent in terms of compliance, which has forced the Indian players to embrace automation and digital quality assurance to sustain a competitive edge and meet global requirements.
Aizant Drug Research Solutions is a scientifically driven and compliance-oriented organization catering to the evolving needs in pharmaceutical contract research, development, and manufacturing (CDMO). Aizant was established in 2008 when the Indian pharmaceutical industry was transforming from being an active pharmaceutical ingredient manufacturing base to a finished dosage forms supplier for the global markets.
The broad range of services provided by the firm encompasses drug substance and formulation development, clinical research, manufacturing, and distribution of pharmaceutical products. “To ensure our vendors are maintaining acceptable standards of quality, we are in the process of implementing a vendor management system in collaboration with our vendors,” says Ramesh Babu M, Vice President – Quality.
Research and Development for Driving Innovation
Another key factor that makes Aizant capable of delivering solutions that suit the needs of their clients is Research and Development (R&D). The R&D team at the company includes highly skilled scientists who work towards creating formulations that are therapeutic to patients and can also be produced in large quantities for commercial use. This balance is particularly important because, often drugs that show efficacy in clinical trials are never commercialized due to issues of scalability.
Aizant applies sophisticated technologies such as spray drying and hot melt extrusion in its production. They are crucial for formulating products that can encapsulate drugs that have low aqueous solubility, which is a major problem in the formulation of drugs. Low solubility may result in low bioavailability, whereby the drug does not circulate in the body to the extent required to produce the desired effect.
“With the help of spray drying, we formulate poorly soluble drugs into solid dispersions that improve their solubility and hence their bioavailability. In the same way, hot melt extrusion makes it possible to prepare multicomponent systems where the release of the active substance is regulated, and the drug is released in the right amount at the right time over a long period,” says Dr. Desu Hari Raghu Ram, Director & Head of Complex Products.
Advanced analytical technologies including Type IV dissolution tester, XRPD, surface area analyzer, Zeta sizer, laser diffraction analysis, ICPMS, DSC/TGA, and Rheometer make an effective combination with advanced formulation approaches at Aizant. Its analytical laboratories have recently forayed into robotics welcoming their first indigenously developed automated sample preparation system thus helping them on their way to becoming a fully automated laboratory using robots.
These technologies are used strategically to place Aizant at the forefront of the development of formulation structures that are complex due to the intensification of formulation as a tool for differentiation in the marketplace among pharmaceuticals. With these benefits, the firm assists its clients to overcome major formulation hurdles hence bringing new drugs to the market faster and at a lesser cost. Its R&D boasts of a successful track record of more than 90% success rate in delivering products to its partners on time for successful commercialization.
Advancing Clinical Research
In the sphere of clinical research, Aizant is making its mark with a specialized clinical trial department that handles operations, project management, medical writing, and clinical data management. The company has strong relationships with its suppliers for clinical trial materials, software solutions, delivery services and PV services. It has completed one pre-clinical, Phase III and BE clinical endpoint study successfully. At present, it is conducting a Phase IV study based on real world evidence with 1500 patients. Some of the upcoming trials are two oncology patient pharmacokinetic (PK) trials, one ophthalmology PK trial in 24 cataract patients and a large Phase III multi-center PK trial in 10,000 patients.
Customer Engagement and Project Management
Transparency is ingrained in its DNA as Aizant’s engagement with its customers is marked by the understanding of the requirements and providing solutions accordingly. It maintains utmost transparency and does not proceed with any partnership when it is not in a position to meet their requirements. Project management teams in the company are charged with the responsibility of overseeing that all projects run as per the planned schedule and cost, which is critical in the industry since any delay in delivery can cost the firm potential revenue and market share.
This approach makes it possible to avoid misunderstandings and, if there are any, to solve them before they exacerbate. For instance, if there is a challenge during the formulation of a product, the team can easily convene the right specialists to address the problem and make sure that the formulation challenge does not set back the project. Such a level of responsiveness is important for retaining the confidence of clients and for delivering on projects.
Hence, in terms of the development of complex formulations, incorporation of sophisticated technology, or the effective handling of issues concerning compliance, Aizant’s approach is commendable. The strategic direction of the firm is what it takes for any organization desirous of delivering safe and effective drugs to the market.
