APV Expert Workshop  | KN 6746

Quality by Design based formulation strategies in continuous processing 05.09. - 06.09.2018 | Leicester LE1 9BH, United Kingdom

Veranstaltungsort

Leicester School of Pharmacy
Gateway House
LE1 9BH Leicester LE1 9BH

Kursprogramm zum Download

Beschreibung

In recent years, DMU has pioneered an innovative partnership with pharmaceutical employers. Key players from the industry including AstraZeneca, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb have been working alongside DMU‘s experts in pharmaceutical education and research to deliver postgraduate training in Pharmaceutical Quality by Design (QbD). The term Quality by Design, now commonly referred to by its acronym, QbD, is a holistic approach to a pharmaceutical product development initiative to modernise pharmaceutical manufacture.

Even though the QbD methodology seems a logical and more efficient way to develop drug products, currently there is limited knowledge in the field of continuous process with respect to critical process factors compared to formulation factors.

This workshop will focus on a strategy to shift from an empirical univariate to a systematic multivariate approach using hybrid batch/continuous manufacture processes with the aim of enhanced process understanding.

Zielgruppe

The level of interest in the pharmaceutical industry in continuous-manufacturing strategies has increased recently. These strategies can accelerate the full implementation of the QbD paradigm for the next generation of pharmaceutical products. In addition to its flexibility and time and cost-saving features, continuous manufacturing is easily amenable to model predictive design, optimization, and control methods.

Current practices in pharmaceutical product manufacture are dominated by batch processing, for which scale-up to commercial volumes can provide numerous technical difficulties and for which studies to provide detailed process understanding can be resource intensive and time consuming. It has been necessary to consider approaches for minimising costs for the development and manufacture of new and existing products. Continuous process manufacturing has many challenging aspects, however it also has many advantages that can offer a more efficient way to produce medicines in the future.

Zielsetzung

The aim of this workshop is to provide a practical experience to delegates with the objectives of:

  • Make real drug products – from powder to tablet, using QbD approach
  • Understand the concept of continuous manufacturing (CM) or a hybrid of batch/continuous
  • Understand the challenges and opportunities using CM so we can use this knowledge to assess the impact that CM would have on commercial manufacturing.

The workshop will be delivered to two/three groups of max. ten delegates. Each group will experience the
full manufacture of tablets from dispensing powders to manufacturing processes and product characterisation.

Referenten

Walkiria Schlindwein

Associate Professor, MSc QbD leader, DE MONTFORT UNIVERSITY LEICESTER (DMU)

Thorsten Cech

Manager European Pharma Application Lab, BASF SE

Mariana Bezerra

PhD student, Technical Support DE MONTFORT UNIVERSITY LEICESTER (DMU)

Preise

  Kategoriepreis
Industry 1.390,00 €
Authority / University 695,00 €
Students 178,00 €
Alle Preise mehrwertsteuerfrei gemäß § 4,22 UStG

Veranstalter

APV-Geschäftsstelle

Dr. Martin Bornhöft
Tel.: +49 6131 9769-0
Fax: +49 6131 9769-69
E-Mail: apv@apv-mainz.de
www: https://www.apv-mainz.de/