PAT Consultancy
supports and guides biopharmaceutical companies in the validation of their production processes and in the realization of comparability protocols for products before and after the modification of a production process. They also support and guide them with Process Analytical Technologies for existing, licensed processes and processes for new products.
PAT Consultancy
has had years of experience in the development of the production processes of vaccines (a special group of biopharmaceuticals), validation of the processes and the application of comparability protocols in the case of modifications of the vaccine's licence. In addition, matters such as specifications of products, stability, impurities (both degradation products as contaminants originating both from the cultivation medium and the cell substrate), handling of process data, process analysis, critical unit operations (namely the parameters, which are crucial for the control of the unit operation) and outsourcing are typical characteristics which determine the identity of PAT Consultancy. The starting point of the enterprise is a series of five guidance documents issued by the FDA as part of their view on the GMPs of the 21st Century. These five documents and their supporting white papers represent a completely new view of this important agency, which is responsible for ensuring that safe and effective medical innovations are available to patients. The most important document in the series is entitled 'PAT- A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance'. This document has had a major impact on the three aspects mentioned in the title and is clarified on the next page of the site. In the document, the preconditions are presented for the realization of 'real time product release'.
E. Coen Beuvery, PhD.
heads PAT Consultancy. At the moment, he is coordinating a project subsidized by Senter, which aims to realize the practical conditions for real time release of a bacterial suspension after its cultivation in a bioreactor. In general, the cultivation unit operation is the most critical one in the production of a biopharmaceutical active ingredient. In this respect, the production of a well-defined bacterial suspension is an additional complexity.
The PAT Consultancy site contains crucial information about the development and manufacturing issues of the PAT Guidance Document and the View of CDER which is part of the FDA organization. It also includes E. Coen Beuvery's résumé and five presentations about subjects related to the typical fields of interest of the companies presented at meetings organized by IIR (England) from 2001 to 2003. These fields of interest are very relevant to the introduction of biopharmaceutical companies.
Contact:
Pat Consultancy
Kerkstraat 66
4132 BG Vianen
The Netherlands
Tel #: 0031347322430/0031347322440
Tel #: 0031646327235
Fax #: 0031347322440
e-mail:
info@pat-consultancy.com
