Perspective On: A Clinical Research Lab

Vaccination Innovation

Making a difference in the world is the main perk of working at this lab

“We develop vaccine candidates primarily against herpes viruses and, in particular, human cytomegalovirus (CMV),” explains Christian Mittelholzer, PhD, chief technology officer (CTO) at Redbiotec. “In addition, we participate in a project funded by the European Union aimed at developing a universal influenza vaccine.”

At the heart of this work is the company’s rePAX® technology, “a highly efficient and versatile assembly and protein expression platform,” Dr. Mittelholzer says, adding that the company “specialize[s] in creating multi-protein, virus-like particles [VLPs] and protein complexes—a process requiring sophisticated molecular biology methods.”

That work takes place in about 4,000 square feet of facility space, which includes a cell culture room with state-of-the-art equipment where the company employs single-use technology that is compatible with industry standards. Currently, Redbiotec has 18 employees, most of whom have PhDs, though some are students doing their master of science thesis work at the company.

Andreas Jurgeit, PhD, business development manager at Redbiotec, says the company’s number of employees is the perfect size for the stage the company is at.

“Everyone can focus on what she or he is best at while always knowing whom to ask if a question pops up,” Dr. Jurgeit says. “All teams interact well, and administration is kept at a practical level. This doesn’t just help us in house but is also appreciated by our partners.”

When new employees start at Redbiotec, they must go through a thorough introduction process that introduces them to all the key aspects of the company’s technology.

“This ranges from the upstream processing part of the workflow—mainly insect cell culture—right through to the downstream processing and analytical steps required to ensure that all final products are of exceptionally high quality,” Dr. Mittelholzer explains. “Even with 20 years of molecular biology experience, it took a while for me to really appreciate the true potential of the rePAX technology, highlighting its inherent complexity and emphasizing the need for intense training when new scientists join our team.”

Workload and workers

In addition to the company’s main focus on CMV and its secondary focus on influenza, Redbiotec is also currently working on many smaller in-house programs and several projects with their industry partners.

“These can have widely different time frames, requiring a structured approach to project management that ensures that all deadlines are met and projects are completed on time—something we have become especially adept at,” Dr. Mittelholzer says. “All of this while also continuing to invest significant internal resources and time to develop our technology even further.”

Redbiotec also keeps those projects organized by storing all documents on a central server that is mirrored and has a physical backup at a remote location.

“There are quite a number of lists and tables with central server access that are updated on a daily basis, allowing all employees, including the senior management team, to keep track of all activities,” Dr. Mittelholzer explains. “On a personal level, I have several tools as well as lists, tables, and brainstorming documents collected in written or electronic form.”

As CTO, Dr. Mittelholzer’s role is to work with the chief scientific officer to coordinate the lab work performed by the Redbiotec team. That involves balancing priorities and resources and translating the company’s strategy into practical lab work. He is also responsible for summarizing results, drawing conclusions, and using that information in the ongoing management of every project.

“This allows us to get the best possible results from every program we work on,” says Dr. Mittelholzer, who started working in the biotech field 20 years ago when he undertook a 10-month diploma program at a major pharmaceutical company based in Switzerland.

“In addition, we conduct internal experiments and prepare data supporting our ongoing business development, often in collaboration with current customers and partners.”

In order to motivate his staff, Dr. Mittelholzer does his best to lead by example.

“I do my utmost to be hardworking, optimistic, honest, and structured while attempting to be fair and realistic about my strengths and weaknesses,” he says. “As we are a small biotech [company] with a range of small and large customers as well as industry partners that we work very closely with, our team needs to be highly flexible, and plans are often revised on a frequent basis. We have a great team that pulls together to drive each other on—and as I’m right in the middle of the projects working alongside them, I can lead by doing as well as by directing.”

An average day at Redbiotec starts off with one or two meetings or telephone conferences with the company’s partners and customers in addition to “many short and sometimes very spontaneous interactions with our lab members,” Dr. Mittelholzer says. “On top of this, we work hard to ensure that our knowledge is always up to date and that we are operating at the cutting edge of vaccinology, which of course means quite a lot of reading and writing!”

The company has four main steps in its workflow and value chain: experimental design, molecular biology, and upstream and downstream processing. Most projects require all those steps as well as advanced analytics and quality control, Dr. Mittelholzer says. And, of course, Redbiotec’s rePAX technology, which is based on the baculovirus expression vector system and is the key technology used in the lab, allowing a high level of protein expression in insect cells.

Dr. Jurgeit adds that the company also uses a number of other technologies in the development process— from bioinformatics to state-of-the-art upstream process development to downstream process development for protein complexes and VLPs.  

Industry challenges and change

While working in research and development is rewarding, Dr. Mittelholzer says it’s also prone to unexpected results and hurdles. “Helping our customers and partners overcome unforeseen changes and deviations in strategy is a key challenge but also an area where our proactive attitude toward customer support adds a lot of value for our customers,” he says. Keeping a strong line of communication between the lab and the Redbiotec business development team is the key to overcoming this challenge.

“This helps me plan and get a feeling for what awaits us in the coming weeks and months,” he says. “That in turn enables me to better anticipate different variables and all possible eventualities; being prepared for changes and new directions is crucial as a lab manager and team leader.”

That personal interaction, both with fellow employees and with partners and customers, is Dr. Mittelholzer’s favorite part of his job.

“Each [interaction] is different and provides interesting dialogue and levels of communication,” he says. “I am extremely structured and like to translate ideas from the team and our customers into successful practical work, to really make things happen. I feel that I can make a real difference there, so this is very rewarding.”

As far as industry changes go, Dr. Jurgeit says that “Although vaccines represent only two to three percent of the global pharma market, in terms of growth rates vaccines outperform the total pharma market by roughly twofold—a fact fueling innovation in the field.” He adds that though the “low hanging fruits” of the vaccine world have already been harvested, a new generation of vaccines such as the papilloma vaccines Cervarix® and Gardasil® have shown that “the market also accepts and supports the development of ‘premium’ products, even if they have to be paid for by the patient directly. This means that vaccines are no longer a ‘commodity type’ product with low margins—they have true blockbuster potential.”

Dr. Jurgeit says that the success of such vaccines means good things for Redbiotec.

“For us as an ambitious but still rather small biotech [company], this opens a lot of opportunities,” Dr. Jurgeit says, adding that Redbiotec’s innovative technology enabling novel products that serve an attractive market is “appreciated by both investors as well as larger industry partners.”

He adds that the new status of vaccines as profitable products has led to major consolidations such as Pfizer acquiring Wyeth in 2009 and GlaxoSmithKline’s recent announcement that it will be taking over Novartis’s vaccine division.

“Very practically speaking, this change in dynamics and renewed interest in vaccines both fuels and enables innovation at a level that one used to see only in the drug development space,” Dr. Jurgeit explains.

He says the lab’s specific plans for the future involve preparing several of its promising vaccine candidates for clinical validation.

“This obviously requires a significant extension of resources from a strong R&D focus towards productcentric personnel and equipment,” Dr. Jurgeit says. “As one example, in our R&D lab we are already applying single-use equipment, which allows us to seamlessly scale and transfer processes. The GE WAVE Bioreactor™ process that is applied to test the expression of candidates can be scaled from single liters to big installations. [This] provide[s] enough material for animal studies and even future clinical validation—all from a single scalable process and within a very short space of time.”

For Dr. Mittelholzer, a technology called BacMam that was recently introduced in the lab is the coolest thing currently going on at Redbiotec:

“Baculoviruses are species-specific, affecting only their host insects,” he explains. “Nevertheless, using a highly artificial lab setup, it is possible to transfect them into mammalian cells. BacMam enables researchers to express their protein complexes and VLPs directly in the host cell, i.e., those affected by a given virus during normal disease development. This is an exciting new method and broadens the application of our expression technology even further.”

Apart from the technology side of things, just being a part of the Redbiotec team and being able to have a positive effect on the world are pretty cool for Dr. Mittelholzer.

“Redbiotec is an exciting workplace where I feel that my skills and my experience can make a difference,” he says. “I’m proud of being a member of our very talented team.”