Portfolio

Below you can find a overview of our most recent projects.

Synco Biopartners, Amsterdam, The Netherlands (May 2012 - current)

Synco Biopartners is a contracting manufacturing organisation (CMO), based in Amsterdam, The Netherlands.

IPCVS supports Synco Biopartners with a new project for an external client by qualifying production equipment, including process vessels and filter housings and validating cleaning and sterilisation cycles.

Crucell, Leiden, The Netherlands (May 2009 - April 2012)

Crucell, an independent vaccine company, has its headquarters in Leiden, The Netherlands. R&D facilities are located in the Netherlands, Switzerland, Sweden and Korea with manufacturing facilities in Switzerland, Sweden, Korea and Spain.

Crucell purchased new equipment and all relevant documents such as URS, FAT/SAT protocols and reports, I(O)Q protocols and reports etc had to be initiated. IPCVS supported the scale-up and manufacturing support group by writing user requirement specifications (URS) for the required equipment and project plans.

Sanquin Plasma Products, Amsterdam, The Netherlands (July 2009 - October 2009)

Sanquin Plasma Products is the pharmaceutical branch of the Dutch bloodbank. They manufacture commercial products based on blood plasma, which is sold both nationally and internationally.

IPCVS assisted the QA compliance department in preparation for a governmental inspection. We also provided assistance in formulating the follow-up actions from previous inspections.

Centocor, Leiden, The Netherlands (July 2008 - April 2009)

Centocor B.V. is part of the Johnson & Johnson group. With production facilities in the Netherlands and the United States, it is the biggest producer of monoclonal antibodies in the world. Well-known products are Remicade and Reopro. These medicines help against heart and artery diseases and auto-immune diseases such as Rheumatoid Arthritis.

The Center of Expertise Cell Culture supports the production department with deviation handling, chasing CAPA’s and quality events and reviewing the production performance. IPCVS was involved in the following activities: initiating and coordinating process changes; coordinating and executing follow ups for CAPA’s; initiating, chasing and presenting CAPA’s to the CAPA board members; carrying out follow up actions / root cause investigations; data collection for cell culture related deviations; revising process related documentation; and writing various documentation regarding the implementation of new production processes.

You can find more information about my work experience in my LinkedIn profile.