Workshop

• Quality by Design
  • Program
  • Registration
  • Contact & Location

BioFarmind and Top Institute Pharma jointly organize on 10 November at the Naturalis, Leiden a one day workshop

Quality by Design

‘Speeding up the process of (bio)pharmaceutical development and manufacturing’

Our changing business environment urges for new (bio)pharmaceutical product marketing strategies. The input of life sciences derived innovations direct towards personalized medicines. With these aspects combined, quality by design (QbD) and its clinical counterpart translational medicine research (TMR) present a new era of (bio)pharmaceutical industry. This speeds up the development of medicines by two times and results in continuous improvement of licensed medicines which will be better suited for patients.

About the workshop
During the workshop three successful examples of the application QbB and TMR will be presented. Also, the consequences of the licensing documentation for new products will be discussed. The A-Mab Case Study in Bioprocess Development will be presented by Kenneth Seamon (University of Cambridge). This case study is written by the CMC Biotech Working Group, which describes the impact of QbD for the development of a new therapeutic monoclonal antibody (Mab).

Trial and Error
(Bio)pharmaceutical process development and manufacturing are traditionally trial and error based activities. Not an extremely effective healthcare strategy, as is exemplified by:
- the long market introduction (12-14 yrs);
- constant governmental interference and controls;
- moderate product performance;
- patent directed pricing;
- low success rate for market introduction;
- the many diseases still to be covered.

Alternatives
Globalization and healthcare effect in terms of demands and costs have stimulated (bio)pharmaceutical industry to look for alternatives. Alignment with quality principles practiced in other industrial sectors, more precisely the semiconductor industries, medical devices industries and automotive industries, offer opportunities for substantial improvement. QdB and TMR offer successful examples in this area.