How has TCG Lifesciences (TCG) evolved over the past year?

TCG was founded in 2001 and has continually expanded its capabilities over the years. Today, we are primarily focusing on the discovery and development of small-molecule drugs. The biggest development over the last year has been the establishment of TCG GreenChem, our US subsidiary with operations in New Jersey and Virginia. We have also moved into the in-silico space and are taking it all the way to AI-driven drug discovery. TCG is also developing translational neuroscience research capabilities utilizing a novel human stem cell platform technology.

Our goal is to collaborate with industry and academia to continuously bring innovative therapeutics to the market. We pride ourselves in being a discovery engine that will hopefully build out a large portfolio of new chemical entities that can one day become marketed drugs.

How important is the US for TCG?

Currently, there is strong growth happening in the biotech industry, with a substantial amount of investment coming from venture capitalists focusing on different types of diseases. The FDA has been extremely swift in approving new chemical and molecular entities with an annual average of 51 new drugs approved in the past five years (compared to only 35 per annum in the prior five year period), and the trend continues in 2022. In addition, the US leads the world in drug innovation, largely due to the depth of biological knowledge and cutting-edge technologies emanating from academia. The federal government is promoting local manufacturing of APIs, and we are actively supporting these activities.

How difficult has it been for TCG to attract and retain talent?

Currently, TCG and its subsidiaries have approximately 1,100 scientists, of which over 280 have PhDs and the balance hold Masters degrees. The current global manpower shortage poses a great challenge as the drug development industry expands, and we felt the impact while setting up our facilities in the US. We are mitigating the challenge by relocating talent from our India team to the US, as well as sharing the work seamlessly across both locations. In India, we have established a strong ability to source talent from academia and impart robust on-the-job training, as well as hire trained scientists directly from the industry. The country has a good network and ecosystem of people which are focused on small molecule drug development.

Can you elaborate on the newly established TCG GreenChem?

TCG GreenChem, with Chris Senanayake, Ph.D. in the roles of CEO and CSO, was set up in the US to leverage the great R&D capabilities and expertise within the country. TCG GreenChem is positioned as a contract innovation company that provides CDMO services with a unique modus operandi in the space of supporting pharmaceutical R&D.

We established an Innovation Center in the Virginia Biotechnology Research Park with access to state-of-the-art facilities that offer a green technology innovation center with novel platforms for catalysis and continuous flow processes. We also focus on developing innovative processes for economical and sustainable manufacturing of APIs.

In New Jersey, we are located in the Princeton South Corporate Center where we have a state-of-the-art facility with unique process-research capabilities that include proper route design utilizing the “First Time Right” concept. We are leveraging the capabilities of the Automated Reaction Design and Flow Technology to accelerate drug development activities utilizing experimental design for reaction screening and engineering. We are involved in developing various catalytic technologies to aid route optimization, prepare intermediates, regulatory starting materials, and APIs. This Center also houses a cGMP kilo laboratory to rapidly scale up chemistry synthesis to support clinical trials.

Can you elaborate on TCG GreenChem’s work on Molnupiravir?

Molnupiravir is a Merck drug that received EUA from US FDA recently. It looks promising as an orally bioavailable drug candidate for the treatment of Covid-19 as positive interim analysis of a phase 3 study demonstrated a reduced risk of hospitalization or death by approximately 50% compared to placebo for patients with mild or moderate Covid-19. TCG played a significant role in developing and scaling up a novel development scheme using a specific enzyme for regio-selective acylation followed by modification of the cytidine moiety and reduced the number of steps that helped decrease manufacturing costs. M4ALL, MIT, and TCG collaboratively established the sustainable and greener process for Molnupiravir for commercialization.