Sai Life Sciences, one of India’s most rapidly expanding Contract Research, Development, and Manufacturing Organizations (CRO-CDMO), has just announced the opening of a new High-Potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing campus in Bidar, India. This facility will be located on the Sai Life Sciences campus. With the addition of this new facility, the firm’s experience in HPAPI development and manufacture has been expanded. As a result, the company is now able to provide its clients with a more simplified route for NCE development.
In making the announcement, Sai Life Sciences’ Chief Executive Officer and Managing Director Krishna Kanumuri stated, “In recent years, there has been a rise in the number of projects involving oncology drugs, which has led to an increase in the demand for high-potency active pharmaceutical ingredients (APIs).
This new facility was developed by our company in response to the expanding demand for our products as well as to take advantage of recent technological advances in the field of HPAPI production. Our ability to meet the varied requirements of our clients has been increased as a result of the newest generation HPAPI production that we have installed at our facilities.”
The following amenities can be found in the brand new HPAPI block that spans 16000 square feet and is situated on the Bidar Manufacturing Campus of the company:
Developed and tested to deal with highly active compounds at a containment level of less than 1 g/m3
Here is all about Sai Life Sciences and the New API Manufacturing Facility;
1. Integrated storage facility for raw materials, intermediates, and final products
A dedicated room for sampling and dispensing, equipped with isolators and three separate streams for processing batches on a commercial scale Reactors that are capable of handling multiple unit operations and are fitted with isolators and split butterfly valves (SBVs) Isolators are available in the powder processing and packaging area, and there is a specific isolator train for quality control testing.
2. A facility for deactivation
At the beginning of the year 2022, the corporation launched the HPAPI Development facility on the Research and Development campus in Hyderabad. Now, with the addition of the new HPAPI production facility in Bidar, the company is capable of handling all aspects of the project life cycle, including process development, analytical development, particle engineering, warehousing, pilot, scale-up, sampling, quality control, powder processing, effluent treatment, packing, transportation, and stability services.
These aspects include process development, analytical development, particle engineering, warehousing, pilot, scale-up, and stability services. In the past few years, the company has been undergoing a significant phase of transformation as part of its Sai Nxt initiative. This has included the execution of investments totaling over US$120M in its capacity and operations, the expansion into new geographies, the growth of its scientific talent base, and the raising of the overall bar for quality, compliance, and performance.
3. About Sai Life Sciences
Sai Life Sciences is a full-service contract research organization and contract development and manufacturing organization (CRO-CDMO) that collaborates with innovative pharma and biotech businesses throughout the world to expedite the discovery, development, and commercialization of small molecules.
To be able to provide its customers with high-quality solutions that are also cost-effective and that shorten the amount of time it takes for those customers to bring their products to market requires a method that is both agile and inventive.
Today, the firm collaborates with more than 200 innovative businesses all over the world and has over 2500 workers spread throughout its facilities in India, the United Kingdom, and the United States. It is backed by worldwide investors such as TPG Capital and HBM Healthcare Investments.
In conclusion, the establishment of Sai Life Sciences’ new API manufacturing facility marks a significant milestone in the pharmaceutical industry. The facility’s state-of-the-art infrastructure, advanced technology, and commitment to quality assurance position Sai Life Sciences as a key player in the API manufacturing sector. With its focus on sustainability and compliance with regulatory standards, the company demonstrates a strong dedication to ethical practices and environmental responsibility. This new facility not only strengthens Sai Life Sciences’ manufacturing capabilities but also contributes to the growth and innovation of the global pharmaceutical industry as a whole.