Wednesday, 20 October 2021

“Our new focus areas are to offer services related to mRNA, plasmid development, GMP manufacturing”

05 October 2021 | Interviews

Bengaluru-based contract research, development and manufacturing organisation Syngene International has recently expanded its biomanufacturing capacity to address the growing demand for outsourced biologics manufacturing and encouraging growth in the biologics business. In addition, the company has adopted a multipronged approach to attract the right talent as a part of its expansion plans. Mahesh Bhalgat, Chief Operating Officer, Syngene International, shares more in this regard during a detailed interaction with BioSpectrum.

The company has recently expanded its biopharma-manufacturing capacity at the Bengaluru centre. Could you elaborate on the units added and how it is aligned with its strategic focus on biologics as one of its future growth drivers?

We have made investments in both mammalian and microbial manufacturing.  On the mammalian side, we have added additional 2000 L single-use bioreactors to further enhance capacity to serve the needs of molecules such as monoclonal antibodies.  Recently, we also announced the completion of our new 500 L microbial facility which further enhances our suite of offerings. Along with being a multiproduct facility, this facility is set up to manufacture protein products and is also suitable for manufacturing mRNA vaccines by producing the plasmid DNA and the mRNA material.  We have also started offering cell banking services for biologics clients and are in the process of increasing the capacity in our GLP-certified viral testing facility, which is a unique facility in the country.

Other aspects of investment in biologics have been focused on increased digitalisation and automation tools such as electronic lab notebooks, training records, and quality management systems tools.  These moves are geared towards our transition to paperless ways of working and help avoid the risk of human errors, but also decrease operational costs and improve time-to-market. The recent investments have increased our production capabilities for bulk drug substance to meet the growing requirements from our expanding client base for end-to-end cGMP clinical and commercial manufacturing.

In the first quarter of FY 22, we signed a five-year agreement with IAVI, a USA-based, non-profit, scientific research organisation, to manufacture three anti-HIV monoclonal antibodies for use in Phase I and II clinical trials. As the development and manufacturing partner, Syngene will provide an integrated solution including cGMP manufacturing of the drug substance and drug product.  Our new focus areas to offer services related to mRNA and plasmid development and GMP manufacturing gives us a unique position in the market.

 

Take us through your talent acquisition strategies for expanding the overall headcount.

Talent is one of the most critical assets for a research-focused innovation-driven organisation such as Syngene and acquiring the right talent pool is an essential part of our overall growth strategy. We have adopted a multipronged approach to attract the right talent. Firstly, we recruit young, fresh minds from various scientific-educational institutes across the country and they then undergo rigorous training through the Syngene Training Academy (STA). The objective of this training is to prepare them for the practical job requirements of the organisation as well as to develop their soft skills. Secondly, given the global clientele that we work with and the cutting-edge science that happens in our labs, Syngene is the first choice for Indian scientists who are based in the west and are looking at returning back to India. Not just Indian scientists in the middle levels, we are also able to attract senior expat talent from the west to be a part of our leadership team. In recent times, we have recruited a number of senior leaders who have worked at various reputed and diverse organisations. They bring with them not only leadership skills but also a deep understanding of the work culture and operating rhythm of our clients from a cross-company and cross-industry perspective.

We currently employ 5400 people, of whom 4700 are scientists based in our laboratories in Bengaluru and Hyderabad working on discovery, development and manufacturing of small molecules, large molecules, oligonucleotides and specialty chemicals.

With the ongoing expansion of capacity in our Hyderabad facility, which is mainly focused on Discovery Chemistry, we have laid a strong foundation by growing our laboratory footprint beyond Bengaluru. Last financial year, we expanded the facility and added capacity for 90 scientists.  We have now launched Phase-III of the expansion, which will allow us to build additional capacity for 300 scientists in addition to the 300 scientists who are already working there.

 

What are the fields of drug research that Syngene is currently focused on?

As a strategic partner to our clients, often working as an extension of their internal scientific teams, we bring them the flexibility and efficiency to scale up rapidly and respond to challenges and opportunities in a result-oriented, safe, and compliant manner. The scientific breadth and depth of our portfolio are contributing to the development of new therapies for a wide range of diseases, with each offering the prospect of making a meaningful difference to the lives of people living with such conditions for example - we are proud of our work to help Albireo Pharmaceuticals develop a new treatment for a genetic liver disease that affects children. Our scientists also work on research projects that focus on leukaemia, Parkinson’s disease, inflammatory disorders, and fibrotic disorders, demonstrating our growing capabilities across complex therapies.  We are also using technology more effectively and have introduced ways to improve toxicological analysis using data analysis based approaches.  As an example, we are now able to reduce weeks-worth of work down to a few mins by avoiding the synthesis of molecules and predicting toxicity endpoints through an in-silico tool.  Such tools help significantly reduce the time for drug discovery.

Our scientific solutions benefit not only the life sciences sector but also the animal health, consumer goods, nutrition, agro-chemicals and specialty chemicals sectors. We work for 8 out of the top 10 pharma companies, our clients include Amgen, Abbvie, GSK, Merck, BMS, J&J, Sanofi amongst others.

 

What is the company's growth projection for the next five years?

The pandemic has been a game-changer for many industries and particularly the pharmaceutical industry.  The trend of outsourcing has only increased with a lot more small biotechs coming up and traditional pharma companies looking at ways to diversify and de-risk.  While we do not give forward-looking projections, suffice to say that the fundamentals of the global biopharma industry remain strong. There is good momentum for new chemical entities and new biological entity approvals by regulators underpinned by a strong pipeline of drugs in the early stages of discovery and development.  The continuing drive to reduce the cost and cycle times associated with drug discovery while driving productivity is expected to increase outsourcing further, with significant interest in the integrated drug discovery and development model. 

On the manufacturing side, growing demand for biologics, huge capacity consumption from vaccines, the capital-intensive nature of the business, and the complexity involved in biopharmaceutical manufacturing is driving demand for outsourcing. We believe Syngene is well-positioned to capture many of these market opportunities. Our Dedicated R&D Centres are seeing good growth on the back of the expansion of ongoing collaborations. The Discovery Services business is driving Syngene's focus on integrated drug discovery (IDD) projects which give us the opportunity to extend our relationship with our clients to every stage of the value chain. In biologics manufacturing, we have expanded our mammalian and microbial capacity.

Our investment plan primarily focuses on expansion across all divisions, capability additions and increased digitisation and automation. We believe all these dimensions of growth contribute to a positive growth environment in the next few years.

 

Sanjiv Das

(sanjiv.das@mmactiv.com)

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