Training Specifically For Tech Transfer Skills Does Exist

By Louis Garguilo, Chief Editor, Outsourced Pharma

Professionals within our development and manufacturing outsourcing ecosystem are quite worried about inadequate training – in-house at their biotechs, and at their CDMOs.
Are we really in such dire training straits?
“I believe so,” says Leonardo Sibilio, co-founder and CEO of Biotech Academy In Rome, whom we met in this editorial.
A main concern of his is a lack of sufficiently trained personnel to perform the various technology transfers to keep our outsourcing industry running efficiently.
However, when workers – including new hires – move into positions of project or product management, says Sibilio, their first duty is often in tech transfer.
“Even if they're brilliant, they do not have the training or knowledge to fully succeed,” he says. Among others, time pressures limit any training "upgrades" they actually do receive.
“It’s always a rush trying to reach end results with the resources available here-and-now. Nobody can stop to train. Even on-the-job training requires strong, sustained efforts,” Sibilio says.
Unless an organization can recruit a seasoned project manager or CMC professional with hands-on experiences with tech transfers, its trial-by-too-many-errors for less experienced employees.
Both sponsors and providers suffer as a result. So may patients.
But now there are paths to overcome this situation.
A CAR-T Tech Transfer
Biotech Academy In Rome offers such paths – at times with interesting twists of sorts.
For example, Sibilio’s team recently designed a targeted tech-transfer training course for a small, Italy-based biotech in the CAR-T space. This organization wanted to scale up viral-vector production needed to produce its therapies, and provide high quality material for their clinical trials.
“This biotech has a tremendous scientific and technical knowledge of their lentiviral platform, but limited experience on how to practically transfer the process from R&D to GMP,” explains Sibilio.
“Producing viral vectors – or any drug substance or drug product in a cGMP format – takes a multidisciplinary approach. Technical skillsets should be accompanied by a rational application of established international guidelines on tech transfer [such as established in ICH Q8 and ICH Q9]”
Biotech Academy In Rome has in fact designed a detailed training course on technology transfer. It focuses on how to accomplish specific tasks, understand what documentations are essential, what technical tools are best to use, and so on.
The course has been given to key professionals in R&D, quality assurance, and of course to tech transfer-designated individuals and teams.
“For example,” says Sibilio, “the course has been conducted in an organization’s own classrooms during two-hour sessions over about a month and a half."
These were interactive and practical sessions, with the goal of personnel learning and applying "standard concepts of tech transfer to the organization’s specific needs.”
Feedback from those who attended was positive, he says, and demonstrated a particular enthusiasm for understanding how to “seamlessly program and prioritize the high number of tasks they had to manage for the transition of their process from R&D to cGMP.”
Sibilio believes this course encompassing company- and employee-level modifications is what is needed throughout our outsourcing industry.
What About University Graduates, And Professors?
Without revisiting logistics of the Biotech Academy In Rome particular to its presence on university campuses (see part one), let’s move to what appears to be a growing number of university students looking to enter our industry.
I have documented previously some biomanufacturing training programs run at universities; Sibilio’s organization is a newer entrant, joining those institutions and organizations introducing students to the idea of working at CDMOs.
“We sincerely believe we can help out here,” Sibilio says of bridging the gap between academia and industry. "This was a key driver for his founding of the Academy after my a long career in the industry."
“If we are ever going to solve for the shortage of skilled workers, and specifically those with an understanding of biotech project management – then we need to recruit more work-ready graduating students.”
The Academy trains two categories within academia: students, and academic professors and researchers looking to exit academia.
That second category, Sibilio says, is of growing interest.
“In our experience, we see these individuals have quite limited knowledge of what it means to actually work in the biopharma industry.”
That gap is not all their fault.
For example, often the R&D labs they’ve been working in at their respective universities are equipped “completely different from the real-life production labs of industry.”
In part one, we spoke about what the Academy is doing to remedy this equipment divergence, including partnering with equipment companies, such as Merck Millipore and Repligen to train on their newest technologies.
Students, their professors, biopharma professionals changing positions, CDMOs handling a variety of new platforms; a whole lot of training needs to take place and tech transfer should be a key component.
Quality Professionals Also Need Training
Along with tech transfer and project management, Sibilio says he’s been training (or retraining) professionals currently working on production staffs in the areas of quality control (QC), quality assurance, and related quality and regulatory units.
Overall, he says, “my experience when I worked at various biotechs and CDMOs was you hire new people who you are always in a hurry to have become effective immediately in day-to-day activities.”
“There isn’t time or a program to explain principles behind a particular technique or piece of equipment, or a certain step, let alone an entire process flow.”
The bright spot?
The CDMOs.
Sibilio says they seem most understanding of the value of outsourcing their training, and have become key clients for Sibilio’s organization, now in year two of operations.
That makes sense, doesn’t it?
As biotechs stay virtual or lean, CDMOs need to be the tech-transfer experts. They need to keep their personnel up-to-speed and as effective as possible to aid their customers.
But it takes two sides to tech transfer.
And doing that more optimally in our fast-paced world may require the outsourcing of training. That should be a natural for us.