Training the Biopharma Industry

How can one ensure that staff are fully competent, with the right degree of technical confidence to work in a highly regulated and scientifically challenging GMP manufacturing environment? How can one optimize staff performance to increase productivity, minimize costly errors, and generate tangible returns to the business? And how can this be done in a cost-effective way while meeting quality standards in a rapid timeframe?

Killian O'Driscoll

These types of questions affect all biopharmaceutical manufacturing operations. Traditionally, to ensure the optimal performance at a manufacturing site, management teams have focused on the quality management of the product and its process. As a result, a wide variety of methodologies and practices have evolved, and a significant variable present at every site has often taken a lower priority: the development of the workforce (see Figure 1).

Figure 1: Key factors in optimal manufacturing performance.

A common approach to training staff involves the "buddy" system. Typically, this approach pairs a new hire with a more experienced colleague who has responsibility for training the new team member. Although this approach has merits, it also has significant drawbacks and can result in an inconsistent training process across an organization.

The challenge of training staff for the biopharma industry has been particularly acute in Ireland, where the pharmaceutical sector has experienced significant growth over many years. The sector accounts for 50% of Irish exports and generated a record €55 billion (approximately US $68 billion) in 2011. Thirteen out of the top 15 global pharmaceutical companies have a manufacturing presence in Ireland, which produce 5 of the top 12 global drug products, consolidating Ireland's position as the largest net exporter of medicines in the world (1).

Following extensive consultation with industry and academia, the Irish government decided to address this training challenge by establishing the National Institute for Bioprocessing Research and Training (NIBRT), which officially opened in Dublin in June 2011 (2). Beginning in this issue of BioPharm International, NIBRT's experts will provide regular expertise and commentary on best practices for key bioprocessing steps (see for Ian Nelligan's perspective on upstream processing). Podcast interviews with NIBRT training experts will also appear online at BioPharmInternational.com/BasicTraining.

THE TRAINING MODEL

NIBRT provides a broad range of training and education programs to a wide variety of companies, including Merck Sharp Dohme, Amgen, Lilly, Johnson and Johnson, Pfizer, Elanco, Genzyme, and Allergan. The organization's approach is based on a Five Cs model, where the Cs represent: Competency-based learning, Customized courses, Certified programs, Continuous professional development, and Cost effectiveness (see Figure 2). These components are described below.

Figure 2: NIBRT’s approach to training, the Five Cs Model.

Competency-based learning

Competency-based learning ensures that trainees have significant hands-on, practical training experience in a GMP-simulated environment. This type of training is typically not possible in an operational manufacturing environment where the equipment is dedicated to production. The NIBRT building, for example, where training is held, holds a 6500-m² state-of-the-art pilot-scale manufacturing plant. The building includes upstream, downstream, fill-finish, and complete process and product bioanalytical characterization facilities. ISPE recognized the plant with a 2012 Facility of the Year award (3).

Customized training

Companies' training needs can be highly variable, making a one-size-fits-all approach inapplicable. All aspects of training, including design, development, and delivery, should be customized to meet the specific needs of a company. NIBRT holds that whether a company is establishing a new facility and needs to rapidly hire and develop a new workforce or cross-skilling experienced staff, novel pedagogical methods that incorporate distance-learning techniques should be used to minimize disruption to normal work practice.

Certified programs

To ensure the highest quality standard and effectiveness of the training, it is recommended that training programs be accredited by a nationally recognized educational body. NIBRT's programs are accredited by partners within the Irish education system, which was ranked 7th out of 134 countries surveyed by World Economic Forum in 2010 (4).

Continuous professional development

Effective training should not be viewed as a one-time event, but rather as ongoing continuous personal development that is an integral part of the organization's culture. Training solutions should have a modular, flexible structure that facilities the integration of training within the workplace.

Cost-effectiveness

Training programs should be benchmarked not only to ensure their cost-competitiveness but also to ensure the effectiveness of the learning outcomes. Where possible, the quantification of training benefits should be documented.

CONCLUSION

Since it opened in June 2011, NIBRT has delivered training programs to numerous global biopharmaceuitcal companies, including Big Pharma, with positive feedback (6, 7). To date, the Five Cs competency-based model has been well received by both the industry and the government. The organization looks forward to sharing its approach and what it has learned in the bioprocessing area with BioPharm International readers in the months ahead.

Killian O'Driscoll is director of projects at the National Institute for Bioprocessing Research and Training (NIBRT) in Ireland, tel. +353 1 215 8100, Killian.odriscoll@nibrt.ie.

REFERENCES

1. Irish Pharmaceutical Healthcare Association, "Pharmaceutical Healthcare Facts and Figures" (2012), www.ipha.ie/alist/facts-and-figures.aspx.

2. NIBRT website, www.nibrt.ie.

3. ISPE, Facility of the Year Awards (2012), www.facilityoftheyear.org/index.php/ci_id/1881/la_id/1.htm.

4. The World Economic Forum, "2009–2010 Global Competitiveness Report."

5. NIBRT Press Release, "Minister Sherlock launches partnership between Waters and NIBRT," Mar. 27, 2012, www.nibrt.ie/cat_news.jsp?i=147&p=100&n=119&cat_p=0&cat=39.

6. NIBRT Press Release, "Online Courses win Taoiseach's Public Service Excellence Award," June 28, 2012, www.nibrt.ie/cat_news.jsp?i=168&p=100&n=119&cat_p=0&cat=39.

7. NIBRT Press Release, "Outstanding Achievement Award for MSD Training Program with NIBRT and IT Sligo," Apr. 5, 2012, www.nibrt.ie/cat_news.jsp?i=151&p=100&n=119&cat_p=0&cat=39.