Ocugen has signed a manufacturing deal with Kemwell Biopharma for a potential treatment of retinal diseases.

The two companies entered the agreement for the clinical production of Ocu200, a novel biologic candidate that could enter clinical trials in 2022.

Ocu200 will first be tested to treat diabetic macular edema (DME), but Ocugen also stated that, depending on clinical success, it could seek to expand treatment targets to diabetes retinopathy and wet-age related macular degeneration.

Image: iStock/naruedom

The potential therapy is a novel fusion protein, which is made up of two human proteins, tumstatin and transferrin.

Ocugen’s CEO, Shankar Musunuri, informed Bioprocess Insider that “Ocu200 is targeting patients who are refractory to anti-VEGF treatment therapies, which is nearly half of the patient population affected by retina diseases.”

Manufacture of Ocu200

Kemwell, a biologic-focused contract manufacturing organization (CMO), will manage CMC and production activities from its facility in Bangalore, India. In addition, the CMO will provide toxicology studies and supplies for Ocugen’s planned Phase I/IIa clinical trials to test the treatment for DME.

Girish Joshi, assistant vice president of business development at Kemwell, told Bioprocess Insider that the manufacture of Ocu200 will initially take place at the 400 L to 2,000 L scale.

Currently, the Bangalore facility has a capacity of 4,000 L but Joshi confirmed that the location has space for expansion, with Kemwell looking to add a further six 2,000L bioreactors.

Why India?

When asked why Ocugen chose to work with a CMO based in India rather than closer to its headquarters in Pennsylvania, US, Musunuri explained that part of the decision came down to capacity constraints in the US.

“Typically, US CMOs are always busy with big contracts and pay less attention to small companies, and therefore, timelines get extended,” he explained

Musunuri also noted that, with the current COVID-19 pandemic, it is currently ‘very difficult’ for other projects to be accommodated by US-based manufacturers.

As a result, Ocugen chose to partner with Kemwell – an arrangement that will ensure clinical manufacturing is met and Musunuri confirmed that this could be extended into commercial manufacture, depending on clinical development.

The Indian contract manufacturing industry is more commonly associated with the production of generic drugs for internal and external markets. However, Joshi outlined that there are now several companies – such as Biocon and Glenmark – that are developing biosimilars and biologic products in the country.

Meanwhile, the Serum Institute of India could play a major role in the mass production of a potential COVID-19 vaccine.

In regard to Kemwell’s position within the Indian CMO industry for biologics, Joshi stated that with over eight years of experience and drug substance and product capabilities, the company is a leader in the area. He added that the CMO is currently contracted to manufacture one commercial drug substance and two drugs products.