Texas spurs bioproduction through industry-academia-led GMP course

The Biotechnology and Healthcare Industry Alliance of North Texas (BHIANT) announced a collaboration between pharmaceutical and biotech services company Panthera BioSolutions and Dallas College to offer a pharmaceutical GMP foundational course for students that are seeking careers in the biotech/pharma sector.  

The program is supported by an $8.8 million grant that the US Economic Development Association (EDA) awarded to Dallas College as part of the Good Jobs Challenge to support growth in the biomedical industry. Jason Mastoris, cofounder of Panthera BioSolutions, told BioProcess Insider that “the initial phase is to create 800 new jobs in the Dallas–Fort Worth area [of Texas]. So there is a marketing outreach program that is actively recruiting students.” 

Those jobs will help to support a burgeoning industry that is still finding its feet in North Texas. Mastoris joined Alcon Laboratories as a consultant in 2011, which at the time was one of the few industry companies in the area. “Back then I noticed most people who worked at Alcon had been there for 20 or 30 years. You got a job at Alcon, you parked yourself there for your career, and then you retired.” He added, “This was not a pharma hotbed.”  

But since that time the region has shown healthy signs of growth. “There’s a lot of investment, a lot of exciting things, and most importantly, a lot of people starting their own companies and trying to develop novel treatments and technologies.” He added that the region now has more than 150 start-up companies in the biotech/pharma sector. Panthera offers multiple services to support that growth, one of which is its foundational course for students. 

Panthera’s foundational course offers 32 hours of training that enable students to survey different industry jobs. Coursework covers documentation, facilities, operations, validation principles, and laboratory operations. 

Half of the total course time is spent in operations where students learn about production planning, aseptic and non-aseptic operations, batch record execution, product controls, material handling, and more. Students also receive a general introduction to pharmaceutical and biotech careers and learn important information about communication and how to thrive within the industry culture. 

The first cohort is composed of eight students that commute from Collin College in Plano, Texas. They attend two days a week and arrive for four hours of GMP training each morning. Jason Mastoris, cofounder of Panthera BioSolutions, told BioProcess Insider that the students had other classes and a lengthy commute, making a four-hour day the sweet spot for balanced learning. “For students that have never had exposure to this kind of thing before, [a full day] can be a lot.” 

A student’s experience begins by simply learning about the many roles available within pharmaceutical production. They are then introduced to GMP and good documentation practices, followed by facilities training, where they learn about the elements that go into designing a GMP facility. Then comes validation, which has been of surprising interest to the students. “Three or four of the eight students want more validation,” Mastoris said.  

Hardik Patel, cofounder of Panthera BioSciences, explained to BioProcess Insider how his organization teaches validation principles to students. He described validation as “basically making equipment and processes acceptable for use in a GMP environment.” He added, “For example, if a refrigerator is being used to store product, it needs to be validated. That means the temperature profile across the fridge must be between plus or minus two degrees.” Students are guided to different pieces of equipment and taught about validation principles for each of them. “So, critical process parameters that are being provided by the equipment to provide a critical quality attribute at the end.” 

Mastoris added that many of the first jobs people take in GMP manufacturing are at an entry level. Traditionally, companies have recruited new hires “off the street” with mixed results.  The foundational course enables recruits to survey a selection of different GMP jobs and form a working understanding of operations that in turn make them attractive candidates to employers. 

But Panthera does not envision its training program ending for college-age students. Mastoris suggested bringing in high school and middle school students and introducing them to a less-intensive version of the course. Patel added, “There are some really bright kids that have already started thinking about what they want to do and where they want to go.”