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Ramesh Subramanian shares insights with LSKH – Life Sciences Knowledge Hub

Aragen Life Sciences Ltd is a trusted R&D and manufacturing partner to the global life sciences industry, with more than 20 years’ experience in providing a range of contract research, development and manufacturing services across the drug development continuum. Ramesh Subramanian is the company’s Chief Commercial Officer.

 

Q. Aragen manufactures both small molecules and biologics. What are the difficulties associated with handling both types of biological substances? It must be quite complex to possess the expertise required to excel in both categories. Could you share your insights on the challenges and how you position yourself as a leader in both fields?

A. We built out our small molecule expertise significantly before our biologics venture. Aragen – then GVK BIO – was a well-known brand in small molecule discovery and development. Nevertheless, we recognised that building biologics capabilities required a different set of skill sets. Hence, we decided to acquire an asset (Aragen Bioscience) that brought us up to speed quickly and provided us with expertise and a track record of success.

Aragen Bioscience, located in the San Francisco area and started by leaders from Genentech, was well-established and fast-growing, highly focussed on science and had an extensive array of solutions in biologics from antibody discovery, through protein sciences and cell line development. We acquired AragenBio in 2014 and since then have focused on investing and growing our business in biologics.

We now offer Gene to GMP solutions in biologics and have augmented our capabilities in the SFO area: adding Process Development and Protein Production and will be investing in a cell line development platform that provides a range of options. Furthermore, Aragen is investing $30 million in adding state-of-the-art Cell Culture Manufacturing Suites in Bangalore for GMP mAb manufacturing. The facility will begin with a capacity of 2.5 KL SUBs and can expand up to 25 KL, and includes design elements that can add Fill and Finish and viral vector capabilities.

Q. Can you share which type of cell line do you work with?

A. We have the tried and tested CHO-DG44 cell line, with its excellent regulatory track record, through which we have delivered over 250 Cell Line Development projects. Four of these projects are now commercial and we have between 10-15 in late-stage development. Very few companies can claim such a track record of success.

In addition, we also leverage the newer CHO-GS and CHO-ZN platforms for customer programs. With our proprietary vector, the CHO-GS platform has shown some excellent results in hard-to-express proteins, with titers improving sixfold in some cases.

Q. Could you share a story of a significant challenge you faced, a product, process or achievement that proved elusive, and how you managed to find an alternative solution? Could you share insights into the current and future obstacles you anticipate, along with your plans for overcoming them?

A. Challenges crop up every day in our line of work. It’s the nature of science, research and development; you’re constantly exploring and developing something new. Consequently, challenges are a part of our daily routine. This is why out of our 4,500-strong team, 4,000 are scientists. We boast the highest ratio of PhDs among CROs and CDMOs, with approximately 13% of our workforce holding doctorates.

We recognise the formidable power of science because we deal with exceptionally complex problems that lack easy solutions. Our approach involves engaging with our clients and finding a feasible solution. Clients may have budget constraints, specific needs or predefined bioavailability targets that can be challenging to meet. We strive to determine the best possible course of action and proceed from there.

One of our clients shared with us an insightful perspective. We’ve maintained a partnership for about seven years, during which we’ve completed projects routinely, each with its unique set of challenges. However, we encountered a significant quality issue at one point. Naturally, we recognised the gravity of the situation and assigned our best people to address it. We delved into the problem, working collaboratively with the client to find a solution. What’s intriguing is that when I subsequently spoke with the client, they revealed something unexpected. They said that throughout those seven years, they didn’t truly grasp who we were as a company.

Everything had gone so smoothly that they had no basis to judge our capabilities. It was only when a substantial issue emerged that they got to know us better. The client explained that excellent companies truly distinguish themselves when confronted with significant challenges. They applauded our transparent communication, openness, collaborative problem-solving and the intellectual rigour we applied to resolve the issue. This experience made them realise that we were the kind of long-term partner they desired.

Q. Could you share some examples of your current and future endeavours in this environmentally-friendly direction?

A. We’ve committed to the Science Based Technology Initiative, aiming to achieve carbon neutrality by 2050. Our primary focus is on green chemistry, which not only promotes environmental sustainability, but also enhances process efficiency. Let me illustrate this with a recent example. Initially, we required 373 kilos of starting material to produce one kilo of the final API. However, through dedicated research and development efforts, we’ve managed to reduce this to just 78 kilos of starting material, a nearly fivefold improvement.

Aragen also established a Center of Excellence in catalysis, covering enzymatic and chemo catalysis, particularly crucial for synthesising chiral molecules efficiently without significant waste generation. Additionally, we’re also engaged in various initiatives, such as planting a tree for every customer visiting our sites, symbolising their connection to our environmental commitment.

Our organisation places significant emphasis on achieving a plastic-free facility and we’re actively pursuing several initiatives in this direction. Environmental, Social and Governance (ESG) principles are central to our corporate strategy, as demonstrated by our recent release of the ESG 2023 report.

In fact, Aragen received a silver rating from EcoVadis and ESG is a fundamental part of our corporate culture, aligning with our mission to save lives in the life science industry and conserve life through waste reduction and sustainability.

Q. Could you share details of any recent investments/expansions and what next for Aragen?

A. We’ve expanded our capabilities by adding a drug product facility to complement our existing drug substance offerings. This means we now offer integrated solutions that encompass drug substance, drug product and toxicology services. On the biologics front, we’ve invested in a substantial manufacturing facility, representing a significant advancement in our capabilities.

While we maintain collaborations with seven of the top ten pharmaceutical companies, we also recognise the importance of working with emerging biotech companies. Currently, we partner with 400+ customers, including many in the biotech sector, as we aim to be their preferred partner.

This transformation journey for the company has been supported by a significant investment from Goldman Sachs and we’ve rebranded ourselves as Aragen. Nevertheless, our core principles of collaboration, dedication and the pursuit of a better future through scientific innovation remain unchanged and continue to guide our company as we move forward.

Source – Life Sciences Knowledge Hub