Kantisto BV is an independent chemical and pharmaceutical analysis consultancy. Kantisto offers support in practical and strategic issues through long or short-term assignments. Kantisto also provides in-company training and courses. Based in the Netherlands, Kantisto delivers its services in Europe and throughout the world. Kantisto can support you with practical technical issues, quality by design (QbD), analytical QbD and also with documentation for regulatory approval such as IMPD/IND, MAA/NDA and SOPs. A focus on knowledge transfer and implementation means that Kantisto prefers to work not just for you, but with you on-site, in close cooperation and collaboration, with a pragmatic scientific and personal approach. Keywords are:• (On-site) Trainings and courses • Scientific supervision and coaching• Method and application development, validation and transfer• QbD and Analytical QbD• Writing or reviewing of SOPs, CMC Module 3 and other regulatory documentation• Troubleshooting and application improvement• E-learning tools• Teaching and lecturing, supervision of students• Capillary Electrophoresis expertiseCombined training and consultancyEspecially in early adaptation of a technique that is new within a department or company, consultancy and training are hard to differentiate. It is most effective in such cases to go by an intensive trajectory of combined teaching and coaching. Such a trajectory can comprise:• Classroom discussion of the basic fundamental properties of the technique• Getting started on the on-site equipment• Translate the just learned fundamentals and good working practices for projects at hand• Interpretation of the results and planning of further experiments• Continued coaching by telcons, webex meetings, site visits and advanced classroom trainings (On-site) Courses and Trainings, both tailor-made and open-registration courses. More information and open-registration course schedule at www.kantisto.nl

Associate Professor Analytical Pharmaceutical Chemistry, Faculty of Pharmacy, Uppsala University, Sweden

Editor at Electrophoresis

CASSS is a global community of industry, academic and regulatory professionals who work together to resolve scientific challenges in the field of biopharmaceutical development and regulation. CASSS members are dedicated to facilitating the sharing of resources, information, and best practices in order to advance scientific knowledge for the benefit of our members and the public at large. We do this through our family of conferences and forums that bring together the right people (experienced in the field), the right way (a culture of engagement), at the right time (timely, scientifically relevant content).

AT Europe is a CASSS meeting. The Analytical Technologies Europe symposium provides and active forum for discussion of recent developments and regulatory considerations of the practical application of analytical technologies like electrophoresis, mass spectrometry and chromatography for product characterization, process monitoring, formulation development and release testing in the biopharmaceutical industry.CASSS is a not-for-profit professional association designed to organize symposia and provide other educational and networking opportunities for separation, pharmaceutical and bioanalytical scientists throughout the world.

2010 (Vancouver) and 2011 (Amelia Island) Symposium Co-Chair of CE in the Biotechnology & Pharmaceutical Industries, a CASSS meeting.CEPharm provides an interactive forum for the discussion of recent development and practical applications of capillary electrophoresis (CE) in the pharmaceutical and biotechnology industries, including regulatory considerations. The forum also provides a venue for industrial CE practitioners to meet, network and participate in exchanging knowledge for mutual education.CASSS is a not-for-profit professional association designed to organize symposia and provide other educational and networking opportunities for separation, pharmaceutical and bioanalytical scientists throughout the world.

Full managerial and scientific responsibility of a department of 16 employees at BSc, MSc and PhD level.Main output of the department:- Analytical support for the pre-clinical and early clinical development of active pharmaceutical ingredients (APIs) and pharmaceutical products, under GLP, GMP or Good Science quality regimes.- Method development, validation, application and transfer.- CMC documentation: Specifications and source documents for IMPD-Q and IND.Strategic activities:- Teambuilding of the new Early Analytical Development department, creating an open, collaborative atmosphere where every team member can contribute with their expertise.- Improving and implementing the early dissolution strategy, organizing training for the whole sector in the role of dissolution in the biopharmaceutical part of drug development.- Responsible for the Science strategy within the Analytical Technology Platform.

Full managerial and scientific responsibility of a department of 16 employees at BSc, MSc and PhD level.Main output of the department:- Analytical support for the pre-clinical and early clinical development of active pharmaceutical ingredients (APIs) and pharmaceutical products, under GLP, GMP or Good Science quality regimes.- Method development, validation, application and transfer.- CMC documentation: Specifications and source documents for IMPD-Q and IND.

Sr Scientist (early) pharmaceutical development in the sector Chemical and Pharmaceutical Development / New Chemical Entities DevelopmentFinal responsibility for the development and validation of analytical methods according international guidelines (ICH) for the release of clinical trial materials. Jointly responsible for specification setting of clinical trial materials.Strategic activities:- Defining development strategy for dissolution methods to support formulation development and starting up and leading regular meetings for multi-disciplinary dissolution group.- Business Acceleration Leadership Team member.- Organization of scientific theme year on chiral separations.- Start up and leading weekly analytical seminars.

Pharmaceutical and Analytical R&D, Södertälje, Sweden- Project responsible scientist representing Analytical Development in drug project teams and in charge of drug projects within department.- Separation expert providing specialist input in drug development activities and introducing new approaches in separation science. Strategic activities:- Responsible for starting up and implementing CE techniques, initializing building of CE corporate network. Chairing CE Core Team and technical skill group. Organized and chaired corporate meetings. - Member of Separations Core Team. In charge of external academic collaborations.- Introducing CGE, cIEF and Lab-on-a-Chip (Bioanalyzer, ALP) within biotech analysis. - Oct 2005 – June 2006: secondment at Solid State Analysis.

Netherlands Organisation for Applied Scientific Research, TNO Prins Maurits Laboratory, Rijswijk.Coupling of μ-LC and CE with flame-based gas chromatographic detectors for the analysis of polar, non-volatile compounds such as toxins, chemical warfare agents and their degradation products.

Orléans, FranceLa mise en route d’un appareil d’électrophorèse capillaire et l’application de cette technique à des produits pharmaceutiques

Volunteer staff member Guest Services, managing bookings, correspondence and guest room planning