Introduction: Creating Successful Professional Training Programs

Over the years, the BioProcess International special supplements have tackled a large number of important topics on emerging trends and new technologies in biomanufacturing, including single-use technologies, continuous manufacturing, cell therapies, and outsourcing. As these and other issues continue to arise and play a critical role in the development of the biopharmaceutical industry, the success of the biomanufacturing industry relies on its ability to attract and retain a well-trained and motivated workforce that can adapt to new technologies and manufacturing challenges.

Recognizing the critical importance of a highly-skilled workforce, the biopharmaceutical industry has played a vital role in making sure education and training initiatives receive the funding necessary to add value, remain relevant, and maintain the capacity to educate the biopharmaceutical industry’s future scientific and technical leaders. In North Carolina, industry’s voice played a central role in establishing North Carolina State University’s Biomanufacturing Training and Education Center (BTEC) as one of the first education and training facilities in the world dedicated to biomanufacturing. It is also, at this point, the largest such facility. BTEC has many unique features, including a simulated GMP 300-L scale pilot facility and a dedicated full-time staff of nearly 50 professionals, most of them with industrial GMP manufacturing experience, who have created integrated, industry-relevant undergraduate, graduate, and professional development programs. The vast majority of the courses offer significant hands-on experiences, and the topics cover all aspects of biomanufacturing: upstream (cell culture and fermentation), downstream, analytical, aseptic processing, and regulatory procedures.

Now, drawing on nearly 10 years of successful experience, BTEC serves a diverse and representative cross section of the biopharmaceutical workforce. This includes process development scientists, chemical engineers, manufacturing operators, and the United States FDA as well as sales, marketing, and product engineering teams from the large network of manufacturers and suppliers that constitute this industry. Despite the wide range and scope of individual work responsibilities, this workforce has a shared need for specialized education and training on the processes that underpin biopharmaceutical production.

These specialized training needs cut across national boundaries. In response, similarly positioned training centers have opened (or are under construction) around the world. BTEC is a successful model from which the worldwide biopharmaceutical manufacturing workforce benefits immensely.

Yet despite the criticality of workforce education, it never has been a hugely popular topic at conferences and in trade journals. Jointly, BPI and BTEC recognized this void, and through preliminary discussions at the BioProcess International Conference in 2015, began a partnership focused on generating an increased level of attention and discussion on professional development in the biopharmaceutical industry.

It is a topic we are passionate about, and we feel that there is much to share. Effective and value-adding professional development experiences can be challenging to implement. Whether it is internally or externally directed, building an education and training program specific to the needs of the biomanufacturing workforce can be costly and time-consuming. It requires answering several key questions:

This supplement is the culmination of a year-long exploration of these questions through conference talks at Interphex and BIO, a survey of BPI’s readership, and articles by and discussions with biopharmaceutical industry-specific educators at academic institutions, companies, and professional associations.

The articles within this issue touch on many of the above questions. Yet there are many other opportunities for discussion and sharing of best practices. BPI and BTEC are hopeful that this supplement is just the beginning of an ongoing dialogue with the industry about the creation of effective professional development programs.