Celebrating a century in biologics, IDT Biologika remains at the forefront of vaccine and biologics development and manufacturing. Ashik Pavagadhi, Vice President, Operations and Site Head of the company’s U.S. outpost in Rockville, Maryland, explains the company’s push to expand in the U.S. market and how ongoing investment in best-in-class technology and a commitment to adapt to meet the changing needs of the industry has led to this unique milestone and will drive IDT’s second century.

David Alvaro (DA): Congratulations to IDT Biologika on celebrating its 100^th anniversary, a truly impressive milestone for any company. What can you tell me about the changes IDT Biologika has seen over this century and what that considerable legacy means to the company and your customers?

Ashik Pavagadhi (AP): IDT Biologika reached this incredible 100-year milestone by continuing our original pledge to make the world a healthier place and to protect humanity from global diseases through the development and manufacture of vaccines. We are among a select few companies in the industry that have been able to maintain their legacy for such a significant amount of time.

To ensure that we continue to serve the needs of the market over the coming century, we are leveraging our unparalleled experience to help advance products that will spare future generations from illness. We’re currently working on progressing our customer products into the clinic and market, including vaccines against infectious diseases such as COVID-19, influenza, smallpox, AIDS, malaria, Ebola, Chikungunya, Lassa fever, and Dengue fever.

DA: How would you characterize IDT Biologika’s vision and mission, and how has that changed over the years?

AP: IDT’s vision is to remain at the forefront of vaccines that offer critical protection to patient populations worldwide and continue to pioneer vital treatments –– we have pursued this goal over the last 100 years. We are enhancing the company on an ongoing basis by investing in best-in-class technology, nurturing our people, and focusing on adapting our operations and services to meet the needs of tomorrow.

DA: What’s your interpretation of the current position of IDT in the European and U.S. markets, and how would you like to see the perception of IDT evolve among buyers of your services in the next few years?

AP: IDT is a well-known entity in Europe, and we benefit from our strong brand identity and presence. We see a great  opportunity  to increase our brand and presence by marketing ourselves in North America and matching the awareness and perception we enjoy in Europe for the U.S. audience. We are aggressively working on creating familiarity and educating the market about our capabilities through increased market exposure.

DA: What do you see as the key differentiators of IDT versus some of your peers and competitors?

AP: One of our main differentiators is certainly the fact that we have been in business for 100 years and have demonstrated our capabilities and expertise across that legacy. With this history comes deep experience in the development and manufacturing of vaccines against infectious diseases. IDT Biologika is one of a very limited number of companies to offer full-service biologics contract manufacturing.

To mitigate risk and reduce the chance of error that has become commonplace when dealing with multiple contract development manufacturing organizations (CDMOs) in an attempt to advance a product to commercial launch, IDT is well equipped to provide end-to-end services to our clients to support their efforts on the delivery of product.

DA: Can you introduce us to the Rockville site and the fundamental focus and capabilities at the site?

AP: Of course. Our U.S. facility is located in Rockville, Maryland in the heart of the I-270 biotech corridor, which is in close proximity to Washington D.C. The Rockville site has a long history as a biologics contract manufacturing site and is outfitted with state-of-the-art technologies. This facility is exclusively devoted to the development and manufacture of clinical trial materials for viral vaccines, viral vectors, and other biologics.

DA: How critical was it to your overall strategy to establish a footprint in the United States?

AP: This push began in earnest in 2015 following a strategic initiative to establish a North American presence. The demand for a geographic expansion was accompanied by a mandate to grow and develop our biologics contract manufacturing offering. We are committed to bringing the state-of-the-art technologies that we use to develop and manufacture clinical trial materials for viral vaccines, viral vectors, and other biologics for our clients in Europe to the North American market. Our plan is to leverage our vast experience in this space to fulfill U.S. domestic demand.

DA: How does the Rockville site interact with the German facility?

AP: There is constant communication between the two facilities and an ongoing exchange of knowledge, which benefits our clients in both regions. To ensure the successful development of the Maryland location, we’ve leveraged our experience in Germany and tried to replicate the guiding principles upon which the facility is built.

Our U.S. team remains focused on the development and production of viral vectors, vaccines, and other biologics. The Rockville facility has taken advantage of the wealth of knowledge and expertise of our German operations and is similarly outfitted to our European headquarters, albeit at a much smaller scale. Both sites are structured such that clients can rely interchangeably on either location to produce high-quality material for both markets. 

DA: What kind of customers do you seek for each site, and what kinds of partnerships do you look to establish?

AP: Our customer base runs the gamut across the industry and includes virtual, small, mid-sized, and large biotech and pharma companies. We also support government agencies and universities.   

DA: What program phases are you able to support? What benefits do customers receive for partnering with IDT from development through commercial manufacturing?

AP: The Rockville site focuses on toxicology and phase I–II clinical supply. As products progress through the clinical stages, we offer technology transfer to Germany to complete phase III clinical supply and eventually  commercial production. IDT Biologika offers end-to-end services to best accommodate our customers.

DA: Can you highlight some specific details about manufacturing at Rockville?

AP: At our U.S. facility, process development is located in the same building as manufacturing. Our teams are cross-trained and flexible, which is a huge benefit for transferring know-how and ensuring a seamless process. Our facility offers cell and virus banking and manufacture of bulk drug substance, as well as final formulation and aseptic liquid filling or lyophilization, for phase I and II clinical supply. These services are supported by our analytical testing and quality groups.

The IDT Biologika team at the Rockville site has experience with a wide range of different cell lines and viruses. We help our customers overcome challenges with their clinical supply by defining the appropriate technologies and employing our experience to refine a process that works, is effective, and can be scaled.

DA: How did IDT Biologika weather the COVID-19 pandemic?

AP: We were fortunate enough to keep the Rockville location open through the pandemic. During this time, we maintained our focus on clinical supply while also supporting our clients in the fight against COVID-19. We are especially grateful to our staff for remaining committed and passionate in the face of adversity, which allowed us to continue operations as usual despite the obvious challenges.

DA: How do you see your customers’ needs shifting over the next decade? How are you strategizing to meet those changing challenges?

AP: The CDMO space is very dynamic and continues to evolve as the landscape changes. The demand for innovative technologies, a more robust clinical supply, and, eventually, faster product life cycles pushes IDT Biologika to continue to invest in resources to improving our scientific, technical, and technological know-how in order to provide best-in-class services and products.