Emergent BioSolutions

Oliver Vogt

The COVID-19 pandemic has brought significant changes to the pharmaceutical manufacturing industry, with a shift towards vaccine production and increased investments in gene and cell therapy. Automation and flexibility in manufacturing are crucial, while the demand for isolator technology and high-speed packaging is rising.

Can you give us a brief background about your roles in the organizations you’ve working for?

As the Vice President of Operations Multisite at Emergent Biosolutions, I hold a pivotal role in overseeing and supporting both our internal products and services business. My responsibilities primarily revolve around our three sites located in Maryland, encompassing a drug substance site and two drug product sites. With a distinguished background in Pharma, Biotechnology, and Medical Device industries, I possess a wealth of expertise in Operations, Engineering, Supply Chain, and Executive leadership. I have demonstrated exceptional capabilities in driving cross-functional collaboration, managing rapid growth, resolving complex problems, implementing turnaround strategies, and fostering cultural transformation. My proficiency extends to strategic planning and execution, enhancing market competitiveness, driving continuous improvement, managing projects and risks, acting as a change agent, developing leadership capabilities, building effective teams, driving revenue growth, achieving supply chain excellence, overseeing engineering management, and managing CDMOs.

Have you observed any new challenges or trends in the space that are transforming the former manufacturing area?

Prior to the COVID-19 pandemic, the manufacturing industry, particularly in the Contract Development and Manufacturing Organization (CDMO) sector, experienced a gradual expansion of capacity to meet customer demands.

Investments were made into biotechnology, specifically in gene and cell therapy, which was expected to be a transformative game changer with numerous products and investments anticipated.

However, the arrival of COVID-19 dramatically altered the industry landscape. Government funding enabled substantial investments across regions, including Canada, to establish manufacturing capacity for monoclonal antibodies, vaccines, and potential novel treatments. The technological shift brought mRNA and viral vector vaccines to the forefront, with mRNA technology emerging as a novel and sought-after approach. This resulted in an overwhelming influx of contracts and immense pressure on the supply chain, necessitating government involvement in prioritizing materials for vaccine production.

While initially, the focus was on monoclonal antibody treatments, the demand swiftly shifted towards high[1]volume vaccine manufacturing using mRNA technology, leaving viral vector vaccines, such as AstraZeneca and Johnson & Johnson, facing significant challenges and decreased demand due to safety concerns and regulatory issues. The market dynamics evolved rapidly, and the industry witnessed fluctuations in demand as well as adaptations to the emergence of variants.

The demand for diagnostics also surged, initially for testing virus infection and later for assessing antibody presence. As the vaccine rollout progressed and variants emerged, the demand for testing continued, leading to sustained high demand and capacity utilization in the industry. However, with the current phase of COVID-19 coming to an end, the demand is expected to decrease, leaving significant idle capacity that needs to be effectively utilized.

Despite the challenges faced, there is optimism for the industry, particularly in the revival of vaccines through the application of new technologies. Numerous programs are underway to replace older technology vaccines and address high-risk pandemic responses, driven by the low-cost application of these technologies. However, it is unlikely that the demand will reach pre-COVID levels. The industry is also witnessing a resurgence in gene and cell therapy, supported by the approval of multiple treatments and promising therapeutic areas. However, the stark contrast in batch sizes and volumes between gene and cell therapy and high-volume vaccine manufacturing poses challenges for contract service offerings.

In response to these dynamics, Emergent Biosolutions has made strategic investments in both small-scale units, such as the Teva facility, equipped with isolator technology for flexible processing of vials, syringes, and cartridges, as well as high-volume isolator filling lines capable of processing conventional containers. The flexibility in product delivery formats positions the company well to adapt to the changing market.

The industry has experienced significant shifts and challenges due to the COVID-19 pandemic, with the focus shifting from monoclonal antibodies to vaccines. While the market remains competitive and the demand for vaccines is expected to continue, albeit at lower levels, opportunities in gene and cell therapy are resurging. Adapting to these changes and maintaining flexibility in manufacturing capabilities will be crucial for success in the evolving industry landscape.

What are the trends you expect to transform the space in the next few years?

The industry’s increasing adoption of isolator technology for drug product manufacturing is driven by the need for improved efficiency and cost-effectiveness. There is a growing emphasis on automation to mitigate operating costs associated with isolator lines. The desire to automate processes, particularly in packaging, is becoming more pronounced due to the pressure to reduce expenses. Consequently, there is a notable increase in investments in this area.

However, the equipment manufacturing industry, primarily situated in Europe, faces substantial challenges regarding long lead times for equipment in this specific domain. As a result, efforts are being directed toward addressing this issue and expediting equipment delivery.

The industry’s trajectory is veering towards automation, both in drug product finishing within isolators and high[1]speed automated packaging. This shift is driven by the pursuit of cost efficiency and enhanced productivity in manufacturing operations.

What would be your piece of advice for budding professionals in the field?

Operating within the current landscape presents significant challenges, particularly due to the diverse range of batch sizes, volumes, containers, and dosage forms. In the early stages of development, especially in the clinical realm, flexibility is crucial. Gene and cell therapy ventures may encounter fewer obstacles regarding volume constraints. Consequently, specializing in this area could potentially reduce the required investments for commercial operations.

“In the ever-evolving landscape of pharmaceutical manufacturing, adaptability, and strategic investments are key to staying ahead. Whether it’s embracing new technologies, navigating market shifts, or optimizing operations, our industry requires a forward-thinking approach to meet the demands of today and the transformative trends of tomorrow”

However, for enterprises involved in vaccine and monoclonal antibody production, substantial investments in high-speed automation and volume processing remain essential. The ability to meet the demands of these sectors necessitates a comprehensive range of offerings tailored to their specific requirements.

The industry’s complex environment calls for adaptability to accommodate various batch sizes, volumes, containers, and dosage forms. While gene and cell therapy may require less emphasis on large-scale production, the vaccine, and monoclonal antibody sectors still demand significant investments in high-speed automation and volume processing to provide comprehensive solutions.

Oliver Vogt has significant experience in Pharma, Biotechnology & Medical Device industries. He excels in cross-functional leadership, managing rapid growth, complex problem resolution, turn-around strategies, and culture change.