deltaPVS, in the person of Pieter van Santen, works as a consultant for the pharmaceutical and life science industry. Together with you, deltaPVS wants to makes the difference for your company to support you in targeting the business goals.
After finishing his study bioprocess technology at the University of Wageningen, the Netherlands, Pieter always worked at biotechnologic processes in the pharmaceutical and life science industry. He occupied several positions, which were all under a quality system like cGMP, ISO9001 and ISO13485. You can hire Pieter for several fields of expertise:

Pieter is capable of supporting your company both managerial and professional. Clients where Pieter worked for are:

Project Management

Based on the methology of 'Prince2', Pieter manages projects on time, budget and quality. A close contact with the client is essential to reach the goal. Pieter worked as a project manager on different kind of projects, such as: Designing, buying and qualifying bioreactors for microbial fermentations for pharmaceutical products The construction of a cold room and a cleanroom production facility Implementing and qualification of sterilisation processes according to different guidelines (FDA and EU) The filling of a vaccin against meningitis Trouble shooting different processes and implementation of the solution The development of a bioreactor system for the cultivation of human stem cells and the biological process in that bioreactor system.

Validation and qualification

Process development

Quality by Design
Pieter has experiences with process development according to the principles of Quality by Design. Where Design of Experiences plays an important role for the determination of the Design Space of process parameters.

Vaccin agains meningitis
At the Dutch national institute for health and environment, Pieter worked at the development of a production process of a vaccin against meningitis. One part was the production process for the cultivation and purification of Neisseria meningiditis. He developed the first chemical defined medium for the cultivation of Neisseria, which makes the growth more reproducible. He also worked at the purification of the vesicles where the antigen proteins were presented to the immune system.
Besides that process, he also worked at the cultivation and purification of protein components of Pneumococcus, which were expressed in E.coli. Because the genes were placed behind a heat shock promoter, the production of the protein was activated by increasing the temperature setpoint of the cultivation. In the DSP, he introduced a homogenator that opened the E.coli because of the enormous shear forces. Chromatography was used during the last purification steps.

Expansion of human stem cells for cell therapie
At Scinus Cell Expansion (before: Xpand Biotechnology), Pieter gave a large contribution to the development for cultivation of primair human stem cells in a bioreactor systen. With this microcarrier based process it is possible to produce therapeutical amount of cells, which can be used in different kind of cell therapy.

Bioreactor development

Trouble shooting

Over the years, Pieter was involved in finding solutions for different kinds of problems within production processes. This trouble shooting was performed in a multi disciplinary team where Pieter combined his expertise together with that of experts to analyse the problem and find a propper solution.

Interim management

Since 1998 Pieter has occupied different management positions, where the content of the discipline always played a major role. From the knowledge of the discipline he stimulates his team members to give their contribution to the big picture. Pieter managed different departments within the scope of biotechnical pharmaceutical processes:

• Production of Active Pharmaceutical Components (API) with cell culture as production platform (Diosynt, now part of MSD-Oss, the Netherlands)
• Formulation of the final bulk and filling it to the final lot under asceptical conditions in a cleanroom (SVM/NVI now part of Bilthoven Biological, the Netherlands)
• Validation and qualification of premises, processes and production equipment (SMV/NVI and Scinus Cell Expansion (before: Xpand Biotechnology), the Netherlands)
• Quality assurance (NVI)
• Development department for the development of a bioreactor including the biological processes (Scinus Cell Expansion)

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