The Secret To True GMP-ness In The Cell & Gene Therapy Sector

By Sarah Boynton, Quality Executive Partners

We can all picture it (or maybe once did it ourselves): a verifier signs off “vector thaw complete” without checking that the lentiviral vial was handled under proper Grade B conditions. A team rushes through a “retraining” CAPA only to make the same mistake the following week. Or maybe an analyst runs a critical sterility assay without proper qualification. Leadership scratches their heads, frustrated. Another deviation. Another retraining. Another fire to put out.

But the real question is: Did they ever understand why it mattered in the first place?

This is even more critical to consider when it comes to manufacturing cell and gene therapies. Each batch may serve a single patient, so those shortcuts don’t merely trigger another deviation. They jeopardize a clinical milestone, a family’s hope, even a life. Training without purpose is noise; it’s like giving a quarterback a playbook and never running the drills. In CGT, that noise echoes down the production line in the form of delayed infusions and uphill CAPAs. And yet, time and time again, we see FDA citations for lack of thorough investigations, inadequate oversight, and weak manufacturing readiness, all of which are symptoms of a deeper issue. What is the problem? We’re not connecting people to the “why.”

I will just be blunt: for too long our industry has lived with the mindset that training and education are compliance boxes to check. Most organizations lean on the weak leg of the “read and understand” sign off to indicate an individual’s ability to be successful at a task or process. This is a lose-lose situation for both the employee and the business. But what about those manufacturing facilities that foster in-depth training, continuous education, and a strong GMP mindset? Well, I can say I have seen both sides of the coin, and the latter breeze through audits and inspections and have happy, compliant employees and an open culture where failures are celebrated as learning opportunities.

When employees understand the “why” behind what they're doing they begin to internalize behaviors rather than memorize tasks. When operators understand that a flawless tubing weld isn’t just about aseptic technique but about preventing a contamination that could halt an $800 K autologous run, they shift from rote task-doers to engaged decision makers. And when supervisors and managers grasp that their role extends beyond signoffs into coaching moments, such as reminding a runner to adequately disinfect materials before handing them into the BSC, they move from compliance enforcers to performance enablers.

According to self-determination theory, when employees understand the purpose behind a task, it supports their autonomy and competence, increasing motivation and buy-in. This leads to internalization, where they adopt behaviors as their own, not because they were told to but because they believe it’s important. This mindset shift fosters what I like to call “GMP-ness”: a professional culture rooted in personal accountability, compliance, and quality-first thinking. CGT training must connect, say, a two-stage media exchange to how cell viability and vector infectivity co-depend. Through active learning and hands-on sessions, simulations, and live role-playing, we turn passive listeners into confident operators.

“But what if we invest in training and people leave?” It’s a common concern, but here’s the bigger risk: what if you don’t invest in them and they stay? The truth is, when employees see a clear connection between their personal growth and the company’s mission, learning stops feeling like a task and starts feeling like a calling. According to LinkedIn’s 2025 Workforce Learning Report, 84% of employees say that learning adds purpose to their work. And we know from Malcolm Knowles’ Adult Learning Theory, adults learn best when:

• they understand the reason behind what they’re learning (relevance and purpose)
• they can connect new knowledge to real-world problems or past experiences
• they’re involved in the learning process and can apply it practically.

Purpose is powerful. It fuels motivation, deepens engagement, and builds loyalty. What could be better for your bottom line? If you want to retain your people, show them that they matter by investing in their development and helping them see how their work moves the mission forward.

Building Habits

Much of what we do in CGT manufacturing is deeply habit-based, Including the cleanroom behaviors, gowning steps, documentation practices, material flow, etc. And research in neuroscience and behavioral psychology shows that habits are formed through cue-routine-reward loops (Duhigg, 2012). Repetition strengthens neural pathways, making behaviors automatic over time. This has two important implications:

1. Good GMP habits take time and consistency to build.
2. Bad habits won’t change without interrupting the loop and replacing it with purpose-driven alternatives (think time and money!).

In CGT, we can map that directly:

• Cue: The controlled-rate freezer alarm sounds, indicating that the patient’s cryopreserved apheresis bag has reached the target thaw temperature.
• Routine: The operator dons isolator sleeve-port gloves, executes sterile welds to transfer thawed cells from the apheresis bag into a wash bag, performs two centrifuge decants, then welds the washed cells into the expansion culture bag.
• Reward: The operator is given a “Sterility Star” badge, the post-wash viability check reads &GT 85 % live cells, and environmental settle-plate counts improve by 0.2 logs.

Over time, those welds and those aseptic techniques and behaviors become reflexive, not forced. Training that focuses only on the what (e.g., “Follow this SOP”) without the why fails to engage the learner’s deeper motivation and understanding. That’s why behavioral drift happens, and even well-meaning operators begin to cut corners if the task feels meaningless.

Incorporating the “why” into training taps into internal motivation and anchors each action in meaning. When combined with repetition (practice) and real-time coaching (feedback), you create the conditions necessary for habit changes and long-term performance.

Training and education in our industry have to be more than “read and understand.” Speaking from experience, successful employees are those that are empowered and confident. When purpose drives learning, performance naturally follows. It’s the difference between “I have to do this” and “I want to do this because it matters.”

For CGT, some of the critical areas where we can focus on building and improving habits through highlighting the why are:

• Vector Handling & Thaw Simulation
  Why: Patient-specific cell therapies and viral vectors are highly sensitive. Any uncontrolled temperature excursion or microscopic contaminant can render a batch unusable for the one person who needs it. By running regular media-fill dry runs with mock payloads and scoring weld-integrity tests alongside PCR-negative swabs, operators internalize a ritualized thaw-transfer sequence. Competency is actually measured. Over time, each freeze-thaw alarm cues an automatic, validated SOP execution rather than a rushed “hope-for-the-best” approach.
• Closed-System vs. Open Tasks
  Why: Choosing the right containment mode (such as isolator versus RABS) directly impacts vector containment, operator safety, and sterility assurance during manual concentration and formulation steps. Decision-tree workshops and hands-on spin-concentration drills turn abstract guidelines into muscle memory. When teams practice both paths in real time, the correct system selection becomes a default reaction, not a last-minute guess.
• Cryostorage and Controlled-Rate Freezing
  Why: Autologous cells’ viability hinges on precise freeze rates and sterile handling. An incorrect freezer program risks cell lysis or microbial growth. Stepwise coaching that covers freezer programming, gown-up sequencing, and aseptic ice sampling, combined with ergonomic thaw-stations, embeds a consistent freeze-thaw routine. Operators come to expect and follow each validated step as a built-in pause point in their workflow.
• Human Factors Checkpoints
  Why: Aligning cleanroom design and digital prompts with natural human behaviors reduces cognitive load, so critical verifications like chain of custody confirmation, cell count, and vector potency never fall through the cracks. Ergonomic mapping of bag-transfer routes and built-in “pause points” in LIMS checklists act as environmental cues.

What are some other actionable considerations for CGT training programs? Think TikTok. Develop microlearning clips involving 3-minute videos on tablet stations in gown rooms where team members can discuss best practices and ask questions. Or consider just-in-time prompts, with QR codes on glove-box ports that launch reminder checklists before each vector addition. And consider how to drive positive reinforcement, such as through the use of RFID competency cards. These are badges that can track last demonstrated mastery of weld technique or cryoprotectant dosing, auto-flagging requalification needs. Finally, we don’t know where to improve if we aren’t aware of our performance. Implement real-time data dashboards that display viable and non-viable counts in the breakroom, so teams see how their gowning and behaviors correlate with environmental trends.

In 2016, Lonza's implementation of their Error Prevention System (EPS) focused on changing behavior through education, awareness, and structured coaching. They took a hard look at how small, repeated human errors were affecting compliance, efficiency, and quality, and then they did something about it. By introducing error prevention tools, coaching conversations, and a performance language, Lonza didn’t just train employees on the what, they taught them the why. The result? Fewer errors. Better decision-making. Stronger accountability. And a culture where people felt empowered to embody quality, not just monitored by quality. When training is consistent, relevant, and reinforced through real-time coaching, it shapes behavior, and behavior drives performance.

FDA 2024: Training Still Tops The Charts

Unsurprisingly, in 2024 the FDA continued to cite training deficiencies as a top reason for Form 483s and warning letters. Examples include:

• Failure to ensure personnel were trained before performing critical manufacturing steps
• Inadequate on-the-job training documentation
• Lack of effectiveness checks following deviations or retraining

What this often points to is a culture that is reactive, not proactive. Everyone can relate because it is the natural progression once the quality system has become overrun by “human error,” and CAPAs are rushed to keep the backlog at bay.

You can’t build a real quality culture without strong training and education. It just doesn’t work. However, when training and education are at the forefront, a quality culture naturally forms. When people understand what they’re doing, why it matters, and how to do it the right way, they naturally start making better decisions. Over time, those good habits turn into a strong culture. But if you try to build that culture without investing in training, you’ll always be chasing mistakes instead of preventing them.

Training + Daily Coaching = Excellence

Training alone can’t do it all. It’s one pillar of excellence, but not the only one. Daily coaching and correction to the standard is where the rubber meets the road. Leaders must embrace their role as performance coaches, not just supervisors. It’s the everyday nudges that hardwire GMP behaviors. This is what builds muscle memory. Think of it like a sport…you can watch film and review plays on paper all day, but if your form is off during daily drills, you'll never be your best on game day. Similarly, you can’t “CAPA” your way out of bad habits or out of regulatory observations. You need practice, feedback, and reinforcement.

The Recipe For GMP-ness

I love to cook in my spare time, often daydreaming about being a contestant on MasterChef while doing so. Having a good recipe makes all the difference. Like a master chef needs the right ingredients and technique, high-performing CGT sites follow this recipe:

1. structured role-based curriculum built for the role with the right training delivered at the right time, detailing the why
2. usable work instructions (SOPs, Wis, BRs, etc.) written and/or reviewed by experts, that are concise, annotated with HFE cues, and version-controlled
3. skilled oversight by leaders trained to give respectful coaching and correction, celebrate wins, and spot drift before deviations occur.

One of the most human parts of working in this industry is growth, not just in skill but in mindset. A lot of us came into the industry early in our careers, doing things the way we were taught or the way everyone else did them, including myself. But as we mature and move to leadership roles, we start to understand the why behind the work. We realize that what once felt like “just paperwork” is actually critical to patient safety and that skipping a small step might not feel like a big deal until we understand the risk it creates downstream.

And that’s where change gets hard. It can be uncomfortable to shift the way we’ve always done something. It takes humility to admit, “I didn’t know better before, but I do now.” But that’s exactly the kind of maturity and mindset that training and coaching are meant to support. When we invest in our employees and give them the space to grow through education, reflection, and real-time feedback, we help them evolve from task-doers into decision makers.

At the end of the day, GMP-ness is about choosing to live the rules in our daily work, especially as we grow and understand more. Sometimes that means doing things differently than we did yesterday. Yes, it might take an investment to get your foundation solid again. You may have to slow down to reassess systems, reeducate, or refocus. But the alternative, like operating with weak systems, unclear expectations, and unchecked behaviors, costs way more in the long run. And ultimately it doesn’t help the patients we serve.

About The Author:

Sarah Boynton is a consultant on the Quality Executive Partners (QxP) team, as well as an adjunct professor at UMBC, teaching courses on GMP and facility design, construction, and validation. She has extensive experience in the biopharmaceutical/cell and gene therapy space, with a particular focus on cGMP training, human performance/error prevention, downstream processing, and non-conformance investigations. Prior to joining QxP, Boynton worked for Catalent Pharma Solutions, KBI Biopharma, AstraZeneca, MedImmune, and GlaxoSmithKline.