The latest phase will see the company, which offers end-to-end development and manufacturing services for biologics and biosimilars companies, start work on installing two 2,000L single-use bioreactor trains in its mammalian CGMP facility.
The bioreactor trains will be added to the company’s 200,000 square feet state-of-the-art manufacturing facility which became fully operational earlier this year. The new manufacturing facility, which caters for drug product and drug substance manufacture, allows Stelis BioSource to offer fully integrated services from early phase development through to commercial manufacture and fill-finish.
In addition to the drug substance and drug product capabilities, which cover process scale-up and CGMP manufacturing to commercial scales, the facility offers the latest analytical methodologies and equipment and operates under Stelis’ fully compliant quality management system.
“Our CDMO facility in Bangalore is already fully operational working on both new and existing customer projects,” said Roger Lias, chief executive officer, Stelis Biopharma. “The investment has been driven by both strong market demand and multiple opportunities to develop an offering for the delivery of affordable outsourced capabilities for biologics.
“At Stelis we’re committed to providing fully compliant, affordable biologics services to facilitate patient access to vital medications. Our experienced team and globally compliant facilities are capable of handling even the most complex projects. Our integrated offering means we can deliver robust and cost-effective processes and seamless manufacturing, allowing customer products to progress to market as efficiently as possible.”
The company, which is dedicated to driving down the cost of biologics, also has plans to develop the site further. The company continues to evaluate further investments into both capabilities and capacity to meet customer demand, including for those driven by the current Covid-19 pandemic.
Stelis’ drug product facility caters for formulation and fill-finish of all injectable formats using isolator-based filling lines for enhanced bioburden control. In addition, it has a fully automated packaging line with a labeler, device assembly system and blistering and carton machines. The facility is also fully equipped to handle products requiring lyophilization.
The site utilizes both conventional and single-use systems to enable multi-product CGMP manufacturing and facilitate flexible project solutions in line with customer requirements.
Stelis also operates a recently expanded 30,000 sq. ft. research and development facility which is also located in Bangalore.