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2021 Annual Report

Describing achievements and activities covering fiscal year July 1, 2020, through June 30, 2021

Despite challenges created by the ongoing COVID-19 pandemic, during the past year BTEC made important strides toward accomplishing its mission: developing skilled professionals for the biomanufacturing industry. Key accomplishments included national and international collaborative activities, record high undergraduate and graduate enrollment, significant growth in its professional development offerings, and continued service to academia and industry through its Bioprocess Services and Analytical Services programs.

Collaborative research and workforce development projects amplify BTEC’s impact

BTEC continued its focus on research and workforce development through a variety of novel collaborative programs with other universities, industry partners, institutes, and various departments within NC State.

AIM-Bio

The Accelerated Innovation in Manufacturing Biologics (AIM-Bio) project is a five-year international collaborative research and workforce training program focused on biomanufacturing science and technology. AIM-Bio, which began in January 2020, is supported by a $27 million grant from the Novo Nordisk Foundation, $18 million of which is allocated to NC State. As part of the grant activities, NC State, BTEC, and the Technical University of Denmark (DTU) are conducting nine new research projects and creating eight new professional development courses important to the future of biopharmaceutical manufacturing. In addition, three of BTEC's existing professional development courses are being transferred to DTU. The project also involves an international collaboration and exchange program for faculty and postdocs, staff, and graduate students at the two universities. Faculty, staff, and students from both NC State and the Technical University of Denmark collaborate on project activities.

To support the program, BTEC hired several new scientific and support staff members during the past year. And although international travel was not permitted due to the COVID pandemic, program participants utilized virtual meetings and other tools to collaborate on research projects, course development, and planning related to the exchange program. During this first full year of the program, work progressed on the development of three online and five hands-on professional development courses. Biopharmaceutical Lyophilization and Spray Drying, the first of the hands-on courses to be offered, was scheduled for delivery at BTEC in August 2021. The three online courses are to be offered in the fall, while the first offerings of the other hands-on courses will take place at BTEC later in 2021 and in 2022. AIM-Bio's nine research projects are on track to meet the metrics outlined in the grant proposal, and in spring 2021, two master’s students at DTU engaged in virtual exchange projects hosted by NC State.

Biomade

Led by BTEC, NC State recently joined BioMADE, the Bioindustrial Manufacturing And Design Ecosystem. BioMADE is the newest of 16 Manufacturing USA institutes and has a mission to enable domestic bioindustrial manufacturing at all scales, develop technologies to enhance U.S. bioindustrial competitiveness, de-risk investment in relevant infrastructure, and expand the biomanufacturing workforce to realize the economic promise of industrial biotechnology. During the past year, BioMADE issued its first two open request for proposals—in Technology and Education/Workforce Development—and BTEC submitted one white paper (pre-proposal) to each project call.

BMIG

The Biopharmaceutical Manufacturing Interest Group (BMIG), is an initiative of NC State's Office of Research and Innovation (ORI) and BTEC. BMIG was established to leverage NC State’s leadership in advanced manufacturing, affiliations with national manufacturing institutes, and existing knowledge and technical resources to form collaborative teams to brainstorm and respond to large joint proposals in the field of biopharmaceutical manufacturing. The aim of BMIG is to establish a strong collaborative network of experts in biopharmaceutical manufacturing among various disciplines and institutions within the UNC system and from industry. BMIG held its kickoff meeting in December 2020 and now has more than 70 registered members, who include faculty, researchers, scientists, industry members, postdocs, and students. In March 2021, BMIG held its first seminar, which featured an invited speaker and was co-hosted by BTEC as part of its annual series. BMIG also has established a website and periodically publishes a newsletter.

CESMII

For a second year, BTEC has been actively involved in CESMII, the Clean Energy Smart Manufacturing Innovation Institute. Over the last year, BTEC has continued integrating its existing data streams with CESMII’s Smart Manufacturing Innovation Platform (SMIP). Currently, BTEC accounts for greater than 90% of the North Carolina Smart Manufacturing Innovation Center’s (NCSMIC) contribution to the SMIP in terms of data points, with over 6,000 points connected to the platform and nearly 500 configured and connected to assets in the SMIP Physical Model. With the recent addition of two new software platforms, LabWare laboratory information management system and PAS-X manufacturing execution system, BTEC is poised to make significant progress toward connecting additional data streams to the SMIP, including raw material and final product test results, with the end goal of creating a fully integrated end-to-end biomanufacturing environment.

NIIMBL

A public-private partnership with the goal of advancing innovation in biopharmaceutical manufacturing, the National Institute for Innovation in Manufacturing of Biopharmaceuticals (NIIMBL) is one of 14 Manufacturing USA institutes, a national network of linked manufacturing institutes that are designed to accelerate U.S. advanced manufacturing. During the past year, BTEC was involved in six research projects — leading three and collaborating in three — that have received ~$1.1 million in funding from NIIMBL. Because NIIMBL technical projects focus on solving industry-relevant biopharmaceutical manufacturing problems, most are partnerships between academia and industry. In addition to industry partners, projects involve collaboration with multiple departments at NC State, including the Department of Chemical and Biomolecular Engineering, the Department of Chemistry, and the Joint Department of Biomedical Engineering.

Academic programs

Undergraduate and graduate enrollment remains strong

For the 2020–2021 academic year, a total of 487 individual undergraduate and graduate students filled an all-time high of 957 seats in BTEC classes, topping the previous year's record enrollment of 893, an increase of 7.2%. By May 2021, 60 undergraduates had completed the BTEC minor during the year, and seven students had completed an undergraduate certificate in biomanufacturing. Among thee 67 students, 12 different academic majors were represented.

BTEC's master's program, known as BIOM, graduated 17 students in 2020–2021 and had 39 enrolled during the academic year. In addition, 14 individuals were enrolled in BTEC’s graduate certificate program during the year, four pursuing the Upstream Biomanufacturing certificate and 10 working toward the Downstream Biomanufacturing certificate. By May, seven students had completed the certificate program, two in the upstream concentration and five in the downstream concentration.

Due to the COVID-19 pandemic, BTEC was unable to hold a graduation ceremony for the class of 2021. However, a congratulatory letter from BTEC leadership and a video from the faculty and staff was sent to each graduate.

Robust employment rates continue

Approximately 70% of the 39 students enrolled in the master's program at BTEC during the past year worked full time in the biomanufacturing industry and attended classes part time. Of the 17 BIOM graduates in 2020–2021, eight were employed full time while enrolled in the program. Of the remaining nine graduates, eight had secured full-time positions in the industry prior to graduation.

BTEC’s graduate program continues to boast a 98% placement rate within six months of graduation. BTEC undergraduate programs have a placement rate of over 95% (employment or acceptance into a graduate program) within six months of graduation.

Scholarships and student activities round out the academic programs

In 2020–2021, 12 undergraduates received BTEC scholarships, which were sponsored by industry firms Avexis, BioMerieux, EMD Millipore, Fujifilm Diosynth, and Patheon Pharmaceutical Service. BTEC staff serve as faculty advisors for the NC State student chapter of the International Society for Pharmaceutical Engineering (ISPE), which provides undergraduate and graduate students with career development opportunities. In addition, BTEC hosted seminars by industry professionals and firms during the year to help develop career-ready graduates.

Professional development

Professional development emphasizes online instruction due to pandemic

Despite the coronavirus pandemic's limiting BTEC’s ability to offer in-person, hands-on courses during the past year, its professional development program reached more professionals than ever by focusing on offering online courses. Although BTEC resumed in-person short courses in December 2020, the size and number of professional development offerings from January 2021 to the end of the fiscal year were limited both by lab occupancy restrictions in place and the hesitancy of companies to send employees to external training because of the pandemic.

Through the past year, BTEC offered two in-person open-enrollment professional development courses and conducted three in-person custom courses and 11 online custom courses for individual companies. BTEC's Fundamentals of Biomanufacturing, a self-paced online course, saw strong enrollment throughout the year; 376 individuals registered for the course.

Contract services

Contract services support industry, academia

BTEC’s Bioprocess Services and Analytical Services units served industry and academic partners from within and outside North Carolina by carrying out 16 projects during the year. They included amino acid analysis on spent media; HPLC analysis for trigonelline and nicotinic acid; HPLC-MS analysis for abamectin; HPLC-MS analysis for fluopyram; production and purification of gene therapy candidates for pre-clinical testing; production of cell culture broth for component testing; resin screening for the development of downstream purification processes for novel peptides for agricultural applications; short-term stability storage of media; structural integrity testing for clean room materials; and technology transfer and scale-up of downstream protein separation for production of testing kit reagents for veterinary applications.