A BPI Theater Roundtable at Interphex 2016

On Wednesday, 27 April 2016, BioProcess International and the Biomanufacturing Training and Education Center (BTEC) at North Carolina State University (Raleigh, NC) presented an afternoon training symposium in the BPI Theater at Interphex 2016.

Brian Caine, BPI’s cofounder and publisher, offered some opening remarks: “The purpose of these theaters and BioProcess International magazine is to talk about trends and their combined impact on bioprocessing. With the tremendous amount of new technology and products, training is imperative for companies wanting to efficiently use new technologies.”

Next, Gary Gilleskie (director of BTEC operations) offered an introduction: “Why do professionals need training and education? New technologies are driving this need. Good business results demand outstanding performance by staff. You want staff who are motivated, smart, and flexible. Those people should be good interpersonal communicators with technical knowledge and skills. The latter two come by having good educational and training programs.

“Learning is not a one-time event, but rather a life-long activity. For example, just training new employees will not help you when technology or regulations change or if you want to move staff around. Everyone needs training on new technology and regulations. Some new technologies include very small-scale studies with miniaturized equipment, continuing advancements of single-use technologies, rapid analysis, and electronic data collection. Resources available for training include internal programs, training organizations such as BTEC that have the ability to give advanced and hands-on training, professional societies, vendors of manufacturing equipment, and consultants.”

Four presentations followed before the symposium wrapped up with a panel discussion at 1:30 pm.

Chad Cooper (Biogen)

As director of manufacturing at Biogen’s North Carolina facility, Chad Cooper is also responsible for training staff. He presented “Beyond Read and Understand: Moving Training from Compliance to Performance.”

With 8,000 employees, Biogen is a worldwide company headquartered in Cambridge, MA. Its primary focus is to develop treatments for multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS, also known as Lou Gherig’s disease). The company has manufacturing facilities in Massachusetts, North Carolina, and Denmark, with a new facility under construction in Switzerland that is scheduled to start up in 2019.

Biogen struggled with its previous training method, which was based on a “read and understand” documentation exercise to demonstrate compliance. Manufacturing employees had an oppressive number of such requirements, and it wasn’t clear how much knowledge they retained. If an employee moved to a new task, he or she was expected to read the relevant standard operating procedures (SOPs). But those neither provided the theory behind the procedures nor gave people the ability to troubleshoot.

Biogen decided to restructure its training program toward emphasizing human performance. Cooper pointed to six factors that affect human performance. The first three are external:

The second three are internal to employees:

Management can control only the first four of those factors, which thus guide the focus of Biogen’s new training program.

The company created a task-based competency-based training structure with a qualification standard that indicates employee proficiency. It took about a year to develop new training content. E-learning courses cover 24 different major unit operations in about 30 minutes each, with a short assessment at the end that employees must pass. Major tasks are broken into 104 total subunits, and performance-qualifying events (PQEs) have been developed. A performance-qualifying assessment (PQA) is an on-the-job performance assessment that must be passed before a staff member can work in a specific unit. Information content covers background, theory, troubleshooting, and explanations (e.g., what a resin does in chromatography). Biogen converted SOPs into work instructions. This new training structure has greatly reduced “read and understand” requirements (from 285 to 21 items).

The company would next like to engage modern learners and create micro-trainings (four minutes long rather than 30 minutes) as well as mobile learning and game-based learning. Cooper said he would like to see biopharmaceutical companies spend 5% of their employees’ time on training rather than the current 1% or less.

Finally, to a question posed by an audience member about developing training, he responded that Biogen makes its own well-produced training videos with a videographer on site.

David Yarley (Fujifilm DioSynth Biotechnologies)

From his perspective as director of Fujifilm Diosynth Biotechnologies’ own bioprocess training and validation academy, David Yarley presented “Effective Theory-Based Training for Operators.” He has 23 years of experience in bioprocessing. After working in production, he developed a training program and saw first-hand the benefits of teaching theory to operators. Then he taught biotechnology at a community college for ten years. Now he works for Fujifilm Diosynth and has brought theory-based training to that company’s 1,100 employees at three sites: Billingham, UK; College Station, TX; and Research Triangle Park, NC. The company has 35 years of experience working as a contract development and manufacturing organization (CDMO) and has worked on more than 270 molecules.

Effective theory-based training gets back to basics by training operators on foundational elements such as the science behind operations, practical mathematics, how equipment operates, the phases of operation and how one unit affects other units, and troubleshooting. Teaching theory is important, Yarley said, because most production documentation lacks such information. “Basic chemistry is the foundation of our industry,” he said. Theory helps operators understand new concepts more quickly, facilitates technical communications, and encourages life-long learning.

Fujifilm Diosynth’s training is a certification program with five functional areas and four core areas. The functional areas are fermentation, cell culture, filtration, centrifugation, and chromatography. The four core technology areas are cell disruption, glass washing and autoclaving, weighing and dispensing, and solution preparation. Each area has a certification program that consists of a pretest, standard operating manual and testing, and qualification testing. A qualifying event includes specific tasks in which employees must demonstrate proficiency. They can continue their training to become subject experts through a more stringent process. The company has introduced theory-based training for all listed areas that includes lectures and discussions to ensure comprehension.

Yardley then discussed how the education philosophies of Mortimer J. Adler are incorporated into his company’s training program. Based on Adler’s works, the three parts of education are lecture-based learning, coaching to teach skills, and Socratic moments of asking open-ended questions. Yardley provided examples and suggested training in the same room where a process being discussed occurs, using real-life examples, team discussions covering recent problems (including causes and solutions), and offering one-on-one time for coaching.

Gary Gilleskie (BTEC)

Gilleskie presented “Process-Oriented Training in Single-Use Technology.” As part of North Carolina State University’s College of Engineering, BTEC has simulated good manufacturing practice (GMP) manufacturing environments and benchtop laboratories to cover all aspects of biopharmaceutical production. Both NCS students and industry professionals can take classes there, and BTEC offers 16 short courses. The center has provided training to US Food and Drug Administration reviewers (1).

BTEC first developed a one-day, lecture-only course on single-use technologies in 2010. In evaluations afterward, the students asked for future classes to be comprehensive and include the newest technologies with hands-on time. For 2015, BTEC designed a new course with lecture and laboratory experiences, expanding its comprehensive course objectives for a broad audience. The facility used a process based on Chinese hamster ovary (CHO) cells to make a monoclonal antibody (MAb) as an example. Classes covered the whole manufacturing process as well as associated financial and environmental considerations. The main challenge in teaching this course was having the right equipment. Partnering with Pall Life Sciences, BTEC accesses both instructors and the latest equipment.

Gilleskie described lessons learned in putting on that course: “It is important to put new technology into context, to be clear about options and issues associated with it, to cover different operations, and to clearly explain the purpose for each component.” Collaboration with vendors is critical, he said, “but try to represent a variety of vendors’ products.”

An audience member asked about who BTEC trains. Gilleskie answered that typically it trains scientists and engineers, whereas a nearby community college provides operator training. Although BTEC does not offer follow-up training, staff members are available to answer questions by phone or email from former participants.

Scott Sommer (Renmatix)

Scott Sommer (a technical fellow in automation and controls at Renmatix) presented “The Challenge of Automation Competency.” Although his company produces industrial sugars from woody biomass, Sommer has worked for pharmaceutical companies in the past, and he develops and teaches courses on automation. Sommer remarked that there is no way to become competent with just “read and understand.” He said that employees must learn by example and experience.

“Automation engineering” is a newly recognized profession for which universities are just beginning to provide curricula. Training and resources can be found through the International Society of Automation (ISA, at www.isa.org), the Automation Group (a loose-knit trade organization), and the American Society of Engineering. ISA lists by task what automation engineers should be able to do and provides an automation-professional test that certifies engineers who pass it.

Every organization is different, but all organizations have similar goals regarding quality, cost, throughput, efficiency, compliance, and customer satisfaction. Automation, in particular, involves goals related to performance, device integration, and use of technology, data, and networks. Companies hope to hire expertise and then expect their engineers to keep up with advancing technology, but many organizations haven’t provided training toward that end.

Sommer encouraged employees to pursue their own self development. He explained that they should learn the basics through classes or degree programs, take initiatives such as volunteering for projects, leverage the knowledge of vendors and professional societies, plan for technical mastery, find a method to verify competency such as by becoming certified, and set a goal for lifelong learning. It is helpful to find a mentor — and in turn to become one. Training and development is self actuated, Sommer said, as well as company-supported and goal-driven. It should be a lifelong process.

Panel Discussion

Moderator Vogel led panelists Gilleskie, Yarley, Sommer, and Cooper in a discussion of how training investments pay off. They began with each panelist offering his insights to interested college students on how they can get experience that will increase their chances of being hired as well as what training they could expect when they start.

Vogel is involved with a facility that offers courses at the University of Rhode Island. Students can gain experience through taking a course, and they receive entry-level training once hired. Cooper said that Biogen tends to hire people with experience but that students near its facility in North Carolina can take courses at NCS and at BTEC to gain such experience. He also touted an excellent community college program in Raleigh that offers training in process operations. Yardley added that Fujifilm Diosynth often hires newly graduated mechanical engineers as temporary employees. Many of them are later hired permanently.

The panelists also discussed a trend of increasing collaborations between industry and academia. BTEC does have an industry advisory board that provides input on what courses to teach and what course contents should include. Gilleskie talked about BTEC’s hope of putting together a course for process operators and automation engineers so that both groups could learn to speak the same language and communicate better. He said that information technology (IT) specialists and automation engineers also need to integrate their work and design systems that are not difficult to operate. Training operators in how to troubleshoot problems on their own would increase overall manufacturing efficiencies.

Scientists and engineers also need “soft skills.” Those include the ability to communicate clearly. The panelists discussed how e-learning and video series might help companies develop their employees’ abilities in this regard. Getting back to company-provided training, one idea was for trainers to meet with employees between shift changes and find out what challenges they are having with their work. Solutions could be discussed and nonconformance incidents might be prevented.

Reference

1 Gilleskie G, Brown P. Comprehensive Hands-On Training for Biopharmaceutical Manufacturing: BTEC’s Program to Deliver Training to FDA Investigators. BioProcess Int. 13(8) 2015: 12–21. •

Alison Center is editorial assistant ([email protected]) for BioProcess International, PO Box 70, Dexter, OR 97431.