Recipharm

Vikas Gupta

In recent years, the mRNA field has evolved rapidly, paving the way for greater innovation across the ATMP space.

In this article, Vikas Gupta talks about his journey as head of ReciBioPharm, Recipharm’s biomanufacturing business unit, his short- and long-term ambitions for the company, and the importance of continuous innovation in driving the industry forward.

Your Key Priorities in This Role and Your Ambitions for the Organization

Since taking the role of head of ReciBioPharm, the biologics business unit of Recipharm, in May 2023, my exclusive focus has been on the fast-evolving advanced therapy medicinal products (ATMP) space that brings together the three companies acquired in 2022: Arranta Bio, Vibalogics and GenIbet.

My priorities include accelerating the integration of these three companies, generating new business opportunities to utilize the process development and manufacturing capacity available across our four global sites, and, most importantly, establishing ReciBioPharm as a well-recognized and well-differentiated CDMO in a crowded market space.

The focus of my global leadership team is on our core site competencies and facilitating knowledge transfer across the entire business unit. We aim to establish Centers of Excellence, offering process development and manufacturing to support preclinical through to commercial manufacturing across multiple geographies, particularly across North America and Europe. This support spans multiple modalities, including nucleic acids, viral vectors, and microbiome-based products.

The key to success is a combination of strong testimonials from our current roster of clients as well as establishing ourselves as a clear thought leader in the dynamic world of ATMPs. Building on our credibility and integrity, we aim to be the preferred partner for advanced therapy pioneers, offering an innovative mindset across development, manufacturing and analytical technologies.

Recibiopharm Is a Different Type of CDMO

Peter Marks, M.D., the head of the FDA’s Center for Biologics Evaluations and Research (CBER), has recently highlighted the importance of enhancing manufacturing through research as part of his four-point plan to accelerate the development and approvals of gene therapies. We firmly believe that a CDMO should play an active role in this area and can be a formidable leader in driving innovation.

Our commitment extends beyond taking on hard-to-solve technical challenges for our clients. We actively contribute to advancing scientific research through projects such as the FDA-sponsored continuous manufacturing process for mRNA-based vaccines. 

We are also continuing to use the latest technologies during the development of this process, as well as incorporating digital-twin models to assist in reducing the design space and machine learning capabilities for predictive and feedback controls.

We endeavor to develop a solution that can enable the manufacturing of up to 240 million doses of an xRNA-based vaccine and can be quickly deployed in any part of the world in case of a pandemic outbreak.

Your Approach to Leadership and Challenges You Faced Since Joining

The post-COVID-19 cliff has highlighted a mismatch in the required experience, scale and capacity to meet the needs of the ATMP market. These challenges require a fresh approach to meeting the needs of our clients. We are ensuring that the right leadership behavior is taught both within our company and in our interactions with our clients.

We’re committed to the basic tenets of transformative leadership, including a steadfast focus on the future, adaptability to change and a strong belief in empowering people.

We are at the forefront of innovation to prepare for the future. As a perfect example, ReciBioPharm, along with MIT, Penn State and RPI, was recently awarded an $82M grant from the FDA to develop fully integrated and continuous production lines for mRNA to aid preparedness for the next pandemic. Our teams of process development scientists and subject matter experts remain abreast of the changing market conditions. For example, as the nucleic acid market is expanding its focus from mRNA to other types of nucleic acid therapies, we are partnering with clients working with saRNA and circular RNA constructs and repeating the success we have had with mRNA projects in the past.

‘We’re committed to the basic tenets of transformative leadership, including a steadfast focus on the future, adaptability to change and a strong belief in empowering people.’

With the current headwinds being faced by both innovator companies and CDMOs in the ATMP space, my biggest challenge has been to ensure that we aren’t inordinately affected by the macroeconomic factors at the individual level and that we continue to focus on what we are great at — delivering for our clients.

Overall, we strive to be a better partner for our clients every single day. Our drive to excel, to exceed clients’ expectations and to establish ourselves as an innovative leader in the ATMP space is in our DNA.