Biotech Scale Up: People


From R&D to Manufacturing

A Chemical Engineer With a Taste for Cell Culture

From R&D to ManufacturingKristina Van Houdt, head of purification technology at Genzyme's Geel plant in Belgium

Kristina made the decision to specialise in biochemistry during her first degree, in chemistry, at Leuven University. She continued to move in the direction of biotech during her PhD, which involved the creation and purification of monoclonal antibodies.

Kristina Van Houdt

With an academic profile geared towards biotechnology, Kristina clearly had the elements in place to enter the industry, and she was hired straight after finishing her PhD in 1991. Her first job--in the research department of Belgian biotechnology company Innogenetics, which specialises in diagnostics and therapeutic products--came in response to a speculative application. "I guess I was hired mainly because of my background as a biochemist/protein chemist and the relevant experience I had gained during my PhD study," she suggests.

Her main duty was to work on the purification of raw materials used in diagnostics and purification of research material such as cytokines and antibodies. "It was there that I broadened my experience of development of protein purification processes," she says. Innogenetics, too, gave Kristina her first taste of manufacturing. "It is through working in a manufacturing environment that I learnt that I have more affinity with a manufacturing-oriented function," she explains. Manufacturing requires a totally different approach from research activities: working on demand, according to predefined specifications, and requiring more planning, co-ordination, and interaction with other groups--things which are fairly unfamiliar in academia.

In 1999, "Pharming had a vacancy for a process development manager," she recalls. Landing the role was pretty straightforward, because "in Belgium it is rather difficult to find people with this type of experience," she reveals. Her new job gave her the opportunity to work with much larger scale manufacturing than her previous job at Innogenetics. In effect, her role was to optimise and scale-up purification processes developed in the Leiden R&D office for clinical manufacturing.

The major difference with her previous position was the much stricter regulatory constraints. Luckily, she had gone through an ISO 9000 certification process--a set of quality management standards--and received training in Good Manufacturing Practice standard inspection while she was at Innogenetics. These experiences proved precious when she started to work in the highly regulated biopharmaceutical manufacturing environment.

When Genzyme acquired Pharming's manufacturing facility in Belgium, "I decided to stay on and learned to work within a much bigger organisation," she says. One of the advantages of working for a bigger company is the opportunity to be involved in bigger projects. In particular, "I am looking forward to the challenge of scaling up as Genzyme's new plant in Geel nears completion," she says (see main story). She will benefit in this effort from the contributions of her new U.S. colleagues, who have firsthand experience of large-scale commercial manufacturing at Genzyme's plant near Boston, Massachusetts.

"Students interested in breaking into the field should choose the relevant manufacturing course as part of their degree," she advises. In addition, "if they decide to go on for a PhD, they need to choose their subject carefully to make sure that what they learn during that period will give them as much experience as possible and therefore makes them attractive for companies," she adds. In biopharmaceutical companies such as Genzyme, "we need people with a good background in either process-related disciplines such as cell culture and purification, or the analytical field for quality control," she says. "Additional experience in validation or quality systems would be of undeniable added-value," she concludes.

Finally, on top of academic skills, working in industry requires the right kind of attitude towards work, she suggests, namely to be open and willing to learn on the job. "A study or job abroad is certainly a plus-point and proves that the person is open-minded and able to adapt to other cultures and work-environment," she concludes.

A Chemical Engineer With a Taste for Cell CultureFrederic,* Head of Unit - Pilot Scale Upstream, Serono Manufacturing Process Development, Switzerland


When Frederic reached the end of his studies in chemical engineering at the Swiss Institute of Technology (Ecole Polytechnique Fédérale de Lausanne, EPFL), he was interested in applying his knowledge of chemical processes to cell culture. At the time, his varied interests--in the use of skin cell culture to treat burns, in human tissue cultures, and in biopharmaceutical production--led him to do his final year, 6-month project on culture in a bioreactor.

The project, which was financed under a joint agreement between EPFL and Serono, gave him valuable CV fodder when it came to applying for a job with the company. But his interest in Serono's work dated back to a meeting with a Serono representative at a student career fair, which clarified the kinds of opportunities available to him.

He joined the company 4 years ago. Initially working on the development of processes for the production of the new proteins in Serono's portfolio, his role has evolved into a more managerial one. Now, as well as managing a group which is developing processes for protein production, he is also involved in R&D for the production of new therapeutic proteins.

In parallel, he has started a PhD through a collaboration between his employer and his former academic institution. "The focus of my study is to characterise the culture systems currently used by Serono in order to understand them better and to identify the main parameters that will help optimise productivity," he says.

And he has further ties with the academic world as he tutors students who do their engineering diploma work jointly between EPFL and the company.

Despite having very little time to put his feet up, Frederic sees his future through rose-tinted spectacles. "The sector offers many opportunities," he says, and in addition: "The company's culture is to give their employees the chance to pursue their own interests through personal development plans and relevant training."

For Frederic the only downside is that the sector is strongly driven by strategic decisions. As a result, projects can be affected by changes in the business direction or by clinical trial results. "Abandoning projects after investing large amounts of time and energy in them for 1 or 2 years can be frustrating," he warns.

Frederic's advice to anyone who would like to go into the biotech manufacturing sector would be: "Develop your own style." What makes the difference at the interview is the candidate's personality. During academic studies, interpersonal skills and management are totally overlooked. So "by learning to be creative and to work in a team, you can make a difference to your chances of employment," he concludes. Such skills can be acquired by getting involved in cultural or sports associations, by living in a flatshare while studying abroad, or simply by attending communication training, he suggests.

* Full name withheld due to company policy.

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