Industrial Doctorate Centre: Biopharmaceutical Process Development

Biopharmaceutical manufacturing continues to evolve with an increased emphasis on underpinning science and engineering. Effective deployment of contemporary knowledge in science and engineering throughout the product life cycle will facilitate manufacturing efficiencies and regulatory adherence for biopharmaceuticals. Fundamental to this paradigm shift has been the drive to adopt an integrated systems approach based on science and engineering principles for assessing and mitigating risks related to poor product and process quality. Changes have been enabled as a consequence of the regulatory authorities introducing a new risk-based pharmaceutical quality assurance system. The traditional approach to manufacture has been to accommodate product variability into the specifications and fix operational strategies to ensure repeatability. Developments in measurement technology have invited changes in operational strategy. This revised approach is based on the application of Quality by Design (QbD), underpinned by process analytical technology (PAT) to yield products of tighter quality and more assured safety. QbD is defined as the means by which product and process performance characteristics are scientifically designed to meet specific objectives. Practical improvements therefore demand a knowledge base of science and engineering understanding to identify the interrelationship between variables and integrate the learning into different manufacturing scenarios. The focus of the Centre is to address the challenges emerging from this paradigm shift and to train a new generation of students with competencies in all stages of commercial biopharmaceutical process development. Critical to this is to ensure they have the skills to work at the discipline interfaces in the areas of biosystem development, upscaled upstream process engineering, and the engineering and development of downstream processing. The training will be formulated around three elements that form the backbone of achieving an enhanced understanding of the process. The three elements are (i) Measurement, Data and Knowledge Management, (ii) Enhance Available Knowledge and (iii) Use Knowledge More Effectively. The power of the approach being adopted is that it is equally applicable to established bioprocesses based on microbial and animal cell culture, as well as emerging areas including stem cells, marine biotechnology and bio-nanotechnology. The rationale for proposing a Centre in this area is to address a well recognised problem, a lack of appropriately trained personnel, who will deliver the next generation of biopharmaceutical development. These issues have been clearly articulated in a series of reports. SEMTA reported that over a quarter of bioscience companies do not have sufficient science skills. 39% of bioscience/pharmaceutical companies have long-term vacancies; with 22% having skill shortages in the science arena (five times that for other sectors). Lord Sainsbury, concerned at the rapidly changing nature of the bioscience business, set up the BIGT and commissioned Bioscience 2015. One of the strong messages raised was the serious shortfall in trained staff. Furthermore a quantitative assessment of the increase needed of trained people entering the sector was made by bioProcessUK. They estimated an increase of 100 trained personnel was required on top of the current 150 doctoral level candidates graduating per year. It is not simply a matter of increasing the number of trained persons. The Centre will also address the limitations of the current UG training of engineers, chemists and biologists which does not prepare them for the challenge of working in process development distinguished by disciplinary interfaces. The proposed programme will address a strategic shortfall and produce a new generation of graduates with the appropriate inter-disciplinary skills to drive both the research agenda and knowledge transfer of underlying concepts into industry.