Case Study - Quality by Design

Sector: Healthcare

Quality by Design

Methods of pharmaceutical development are changing more rapidly than the skills base in the bioprocessing industries. In order to remain competitive and retain market share, organisations of all sizes need to ensure that staff can function effectively within the new regulatory frameworks arising from changes made by the US Food and Drug Administration (FDA).

These changes have meant that developments in measurement technology, commonly termed process analytical measurement, have opened up the opportunity to change operational strategy in the pharmaceutical sector. This revised approach is termed Quality by Design (QbD) and is about responding to variation to produce products of tighter quality and more assured safety.

Integral to QbD is process analytical technology (PAT) which places new demands on industrial staff and requires them to develop a new set of skills.

Emerging skills challenges

The Bioscience Innovation Growth Team (BIGT) and The Sector Skills Council for Science, Engineering and Manufacturing Technologies (SEMTA) have raised serious concerns about a shortfall in the number of trained staff in the bioscience area; although the UK is a global bioscience leader today, it is in danger of losing that position by 2015.

PAT raises important scientific challenges that place new demands on industrial staff: skills in measurement, data interpretation from complex signals, process systems and process operational improvement including control will, over the next few years, be crucial in the bioprocess developer toolkit. These skills are not traditional strengths for those in the bioprocessing industries who tend to have backgrounds in biological science or biochemical/ chemical engineering.

The response

Professors Montague and Martin of Newcastle University have considerable research expertise in the PAT area and a sound understanding of the needs of industry. To ensure development tailored to industrial skills needs, they met with contacts within pharmaceutical companies in the UK and the USA. These companies, known to be pursuing the PAT agenda, covered the different forms of business in the sector (contract manufacturers, traditional pharmaceutical companies and measurement suppliers). Companies ranged from medium to large and covered the three main forms of manufacturing – large and small molecules and vaccines.

All the industrialists highlighted the need for courses on intelligent modelling and data interpretation to be designed and delivered by people with considerable expertise and experience of PAT. A course that placed the tools in context, integrated fundamental process understanding and enabled attendees to link the outputs of analyses back to process enhancements was felt to fill a market gap.

The Process Characterisation and Understanding course developed to address these needs provides a brief refresher to ensure that all learners have the necessary baseline knowledge and understanding. Then over three days experts from industry join forces with academic staff to deliver a mix of theory and practical skills. Using case studies to reinforce the theoretical material by illustrating its practical application ensures that learners are able to see the relevance to their own industrial context.

Impact

The pilot course, attended by 16 delegates from a range of organisations, was well received and provided valuable information on how the course can best be developed for future delivery. Course leaders have had requests for permission to distribute course notes to colleagues and enquiries about dates for future courses.

Healthcare is a key strategic focus in the North East and this course makes a direct contribution to the development of skills in this area. Expertise developed through research at Newcastle University is shared to ensure that organisations can maintain a position at the cutting edge. For a medium-sized organisation such as Avecia, says Chief Scientific Officer Mark Carver, “Quality by Design is an increasingly important framework for biopharmaceutical development and the PAT courses offered by Newcastle University are ideally suited to our needs”.

The value of Quality by Design is not exclusive to the pharmaceuticals sector though. Cadbury may not be the first name that springs to mind when thinking about this area but Andrew Bufton thinks it is important not to pigeonhole people too much in terms of industry area. Having attended the course, Andrew says “There is a broader application of these skills and it’s very valuable to mix with people from other industries and understand how they are using these processes.

Using case studies gave us the opportunity to apply the skills we learned about in lectures.”

Offering opportunity for informal follow up by phone or e-mail after the course allowed participants to tap into a network of support as they took their new skills back into the workplace and applied them to organisation-specific challenges.

Further information

Course specific

General enquiries

  • Mr Christopher Hoy, christopher.hoy@ncl.ac.uk
  • Teaching and Learning Awards Officer
  • Research & Enterprise Services
  • Telephone: +44 (0) 191 222 5886

 

Quality by Design brochure

View our PDF brochure Quality by Design: using process analytical technologies (PDF: 1.06MB)