Business

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…

Advancing the Biopharmaceutical Community Through Learning and Development Partnerships

As in most high-tech sectors, success within the highly regulated biopharmaceutical manufacturing industry depends upon an adaptable, skilled, educated, and high-performing workforce. The impact of human performance cuts across the entire industry — whether for a manufacturing operator, a scientist or engineer in a highly technical role such as process development, or a technical sales representative serving the industry. The effects of poor performance can be seen easily in deviation reports and FDA warning letters as well as in quantified…

Designing In-House Training Programs: Moving Beyond Read and Understand

To begin the discussions in this issue about structuring successful training programs, these authors describe how to develop in-house resources. Both emphasize the need to assess the impact of previous training approaches. An important factor is to understand that students will bring varying levels of knowledge and relevant experience to their work with your company. So how do you structure a training program that takes into account individual learning styles and operational expertise? How to you measure the successful application…

Training for New and Emerging Technologies: Building Comprehensive, Process-Oriented Competencies

Assessing the need for training that addresses the varied needs of your employees requires looking far beyond a one-size-fits-all approach. Few companies, however, have the internal resources to develop truly comprehensive programs on their own. Successful training approaches are those that enable end-users, organizations, and suppliers to share needed equipment and expertise. At the 2016 BioProcess Theater at Interphex, Gary Gilleskie (BTEC’s director of operations) and Scott Sommer (a technical fellow at Renmatix) detailed examples of successful training programs for…

Measuring the Impact of Investments in Professional Development: A Virtual Roundtable

Well-designed education, training, and professional development programs and partnerships add considerable return on investment to stakeholders across the biopharmaceutical manufacturing industry. As biomanufacturers, suppliers, and regulatory bodies share similar workforce needs, focused education and training efforts can lead to increases in productivity, yield, and employee engagement and retention. In addition, education and training programs can decrease the incidence of deviations, which are costly to investigate and remediate. Yet when compared with other business needs, training, development, and human performance initiatives…

Exploring Academic Models for Biomanufacturing Education

Undergraduate and/or graduate programs in physical and life sciences can provide a solid background for science and engineering students who are interested in careers in biotechnology research and development. Yet many such programs have not adequately prepared students for careers within and related to the biopharmaceutical industry. In today’s globally competitive job market, developing a workforce pipeline for the bioprocess industry requires academic programs that equip students with knowledge, skills, and theory surrounding the equipment, methodologies, processes, and regulatory requirements…

Demographics and Trends: Results from a Joint BPI/BTEC Survey on Training

Training is an investment. And it’s one that the authors, contributors, and other individuals behind this supplement understand well. However, the biopharmaceutical industry is much larger than these few individuals. It’s just as important to understand the motivators, drivers, and training-related challenges faced by the industry at large. So BPI and BTEC jointly administered a short survey to gather some basic information from the magazine’s readership about the value and role that training plays in their organizations. According to survey…

BioPhorum Operations Group Technology Roadmap, Part 1: Four Trends Shaping the Future of the Industry

What prompts over 100 biopharmaceutical manufacturers, leading academics, supply partner R&D heads, regulators, and worldwide regional hubs to get involved in a major project? It’s when that project identifies the future technology needs of the biopharmaceutical manufacturing industry and accelerates its collective innovation. In February 2015, the BioPhorum Operations Group (BPOG) Technology Roadmapping steering committee met in Washington DC to create the first “technology roadmap” for the biopharmaceutical manufacturing industry. The biopharmaceutical market has been experiencing dramatic changes: explosive growth…

India’s Next Steps: Quality Improvements Target International Markets

India’s position as a global participant in small-molecule generic drugs, vaccines, and enzymes has been proven over decades. The country is one of the most populous and fastest-growing regions in the world, both economically and technically. But India’s potential as a biologics participant has not been realized. Its competence as a global biologics producer has not yet caught up. Global industry concerns regarding the country’s position in the (bio) pharmaceutical industry haven’t changed much over the past eight years since…

Funding for Life-Science Ventures: Accelerating Innovation in Tools and Services

As a cofounder of Wave Biotech (now a division of GE Healthcare), my partners and I often struggled with critical choices regarding partnering and funding opportunities. Every new, attractive, and potentially disruptive technology will court attention once it experiences some modest adoption and acceptance, even while attempting to “fly under the radar” of major players. The challenge for life-science entrepreneurs is how best to navigate those decisions and select the right path as company founders. Weighing and evaluating potential partners…