Christopher Cole

In the first-ever “Two-Minute Mysteries: BioPharma Stories,” Agilent’s Ken Boda shares the mystery of a low reading.

Two-Minute Mysteries: BioPharm Stories - Episode 1: The Mysterious Cause of a Low Reading



In this inaugural episode of the “Two-Minute Mysteries: BioPharma Stories” video series--created in partnership with our sister publication

--Ken Boda, a dissolution product specialist at Agilent Technologies, shares the story of a mysterious low reading.

Ken Boda
Dissolution Product Specialist
Agilent Technologies

Ken works primarily with customers in the US and Canada. He has a wide knowledge of analytical methods, method development, validation, and regulations in the pharmaceutical environment. He enjoys educating people on the science of dissolution and helping customers work through their method challenges.

Specialties: Dissolution Method Development and Validation, Dissolution Failure Investigations, HPLC, UV, Physical Testers, well-versed in USP, FDA, and ASTM regulations in regard to pharmaceuticals, nutritional supplements, and medical devices.

Find Ken on 

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.



Hi, my name is Ken Boda. I'm a dissolution product specialist with Agilent Technologies. I wanted to share a little, scientific mystery with you. Oftentimes, when we're working with dissolution and we have a failure, these can present as little mini mysteries to try to do a failure investigation, determine what's going on.

One example of a quick mystery is a customer of ours who had a dissolution with baskets and a disintegrant dosage form, and they had unexplained low results on a particular dissolution bath. They asked us to come out and take a look at it. We brought our 280-DS mechanical qualification system to the site to evaluate the system.

We found that the alignment of the system was good. However, we did note that there was some interesting spikes in vibration over time, and it turned out that the vibration was coming from a refrigerator that was on the same bench top as the dissolution. So what was going on? What was causing those low results?

Well, when we have spikes in vibration in a disintegrant dosage form in basket, we can shake that basket out and we end up having the powder land on the bottom of the vessel, and at the bottom of the vessel, we don't have much mixing. And so, as a result, we have a large amount of drugs sitting at the bottom of the vessel where it can't dissolve.

And that leads us to having low results. This is really important to monitor vibration and dissolution, because it can have a lot of interesting effects. We usually think of vibration causing higher and more variable results, but that's not always the case as evidenced by this basket study. So, thank you, and hope you enjoy the rest.

Videos

We highlight the week’s industry news in an easy-to-consume, fun format.

PharmTech Weekly News Roundup - Week of September 15

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

ABC Farmaceutici to Celebrate Centennial at CPHI Frankfurt

ABC Farmaceutici will commemorate its 100th anniversary

 at CPHI Frankfurt from October 28–30, 2025, unveiling a special logo and hosting an event at its booth. The company, now part of ICE Pharma, has expanded globally into over 50 countries and developed expertise in active pharmaceutical ingredients (APIs), dermo-cosmetics, and ursodeoxycholic acid (UDCA), a treatment for a rare autoimmune liver disease.

CPHI Frankfurt Announces 2025 Pharma Awards Finalists

 have announced finalists across 14 categories, highlighting innovations in synthetic biology, artificial intelligence and sustainable packaging. The awards underscore the industry's shift towards digital tools and green practices, with winners to be revealed at the CPHI Frankfurt opening ceremony on October 28.

Cancer Research UK and Nxera Launch Phase IIa Trial for Immuno-Oncology Drug

Cancer Research UK and Nxera Pharma have begun a Phase IIa clinical trial for HTL0039732

, an investigational small-molecule immunotherapy for advanced solid tumors. The drug targets the EP4 receptor to address tumor-mediated immunosuppression, a different mechanism from traditional checkpoint inhibitors, and will be tested in cancers with high unmet needs, including colorectal and prostate cancers.

Competition Intensifies in MASH Treatment with New Drug Approvals

market for metabolic dysfunction-associated steatohepatitis (MASH) is expanding rapidly

 following the FDA's approval of Madrigal Pharmaceuticals' Rezdiffra and Novo Nordisk's Wegovy. With the MASH market projected to reach $31.8 billion by 2033, major pharmaceutical companies like Eli Lilly, GSK, and Boehringer Ingelheim are advancing their own innovative therapies, creating a highly competitive landscape.

FDA Issues Warnings Over Misleading Drug Promotions

FDA issued warning letters to Eli Lilly, Novo Nordisk, and Hims & Hers Health

 for misleading promotional communications regarding popular weight-loss drugs. The warnings specifically criticized a television program for omitting and minimizing significant risk information for drugs like Mounjaro and Ozempic, signaling heightened regulatory scrutiny of advertising practices across all media platforms.

FDA Approves Enbumyst, a Nasal Spray for Edema

, a bumetanide nasal spray for treating edema associated with congestive heart failure, liver, and kidney disease. Designed as a self-administered outpatient therapy, the nasal spray offers rapid absorption comparable to IV diuretics, potentially reducing hospitalizations and healthcare costs for the 6.7 million Americans with heart failure.

The week's pharma news includes FDA warnings for Lilly and Novo, new drug approvals for MASH and edema, and a look ahead at CPHI Europe.

Conceptual stop sign with stormy background. Warning, caution and danger sign | Image Credit: © Rechitan Sorin - stock.adobe.com

The pharmaceutical industry stands at a critical juncture, as a recent report suggests FDA is considering a significant departure from its long-standing practice of utilizing external expert advisory committees for new drug applications (1). This potential shift, initially signaled by George Tidmarsh, head of FDA’s Center for Drug Evaluation and Research, has profound implications for regulatory strategy, transparency, and internal quality systems, directly impacting the core concerns industry professionals.

Historically, FDA advisory committees, established in their current form in 1972, have served a crucial role by convening external experts to review evidence and vote on the approval of drugs, vaccines, and medical devices, particularly when the agency faces complex or difficult decisions (2). Tidmarsh, however, argues that these panels are redundant and time-consuming, involving "a tremendous amount of work for the company and for the FDA." He suggests that the agency should instead focus its efforts on "big questions," such as evaluating appropriate endpoints for different drug classes.

A key part of the FDA's rationale for this potential change is the recent initiative to publish Complete Response Letters (CRLs) in real time (3). These letters, which previously required Freedom of Information Act requests, provide developers with "early insight into regulatory deficiencies to improve development planning." Tidmarsh posits that releasing CRLs promotes a level of transparency "akin to the advisory meetings’," suggesting the letters make expert committee meetings on individual drugs redundant (1).

However, this perspective is met with considerable pushback from former FDA officials, academics, and industry experts. Critics argue that abandoning expert reviews would "shield the agency’s decisions from public scrutiny” (1). Robert Califf, former FDA Commissioner, finds Tidmarsh’s reasoning "hard to follow," emphasizing that it is "extremely useful for people inside FDA to find out what other experts think before they make their final decisions" and essential for public understanding (1).

How do CRLs and expert review committees differ?

Experts highlight several critical differences between CRLs and advisory committee meetings:

• Public Input and Dialogue: Advisory committees allow experts to ask questions of the company or FDA that might not have been considered, and provide a vital public forum for comment on FDA decisions (1). A disclosed CRL informs the public 

 an application was rejected, while an advisory meeting seeks 

 a decision is made, a crucial distinction.

• Internal Consensus and Scrutiny: Committees often help settle disagreements within the FDA itself, providing an external, unbiased perspective that can strengthen decisions (1).

• Rigorous Evaluation: While the FDA is not obliged to follow committee votes, their input is particularly valued for "important new types of medications or when a decision is especially tricky because of high demand for a product that may have limited value," as exemplified by the controversial approval of Biogen's Aduhelm despite a "no" vote from its advisory committee (4).

For industry professionals, this potential shift carries significant implications across various domains:

Companies will need to closely monitor how drug approval pathways might evolve. If external expert validation becomes less common, drug developers may need to anticipate heightened internal FDA scrutiny or adjust their data submission strategies to preemptively address potential concerns that would typically be vetted in a public forum.

Quality systems and compliance excellence

A less transparent or externally validated regulatory environment could place even greater emphasis on robust, holistic internal quality systems to ensure compliance excellence and mitigate risks without the benefit of public expert debate (5,6). Ensuring data integrity and quality of data will become even more paramount for regulatory compliance and patient safety (7).

The pharmaceutical industry operates under intense public scrutiny. A move away from public advisory committees could, as critics suggest, reduce transparency and potentially erode public trust in drug approvals (1). This would necessitate companies to be even more proactive in communicating their commitment to quality and patient safety.

While Tidmarsh indicates committees would still be consulted on general regulatory issues, the absence of detailed, specific drug reviews could alter how industry and the FDA collaboratively address emerging scientific and manufacturing challenges (1).


Evidence of this shift is already emerging, with the FDA holding only seven advisory committee meetings since the current administration entered the White House, compared with 22 in the same period last year (1). While some initially viewed this reduction as temporary, others perceive it as a "strategic" move to "consolidate power in the agencies" and reduce accountability to outside experts or the public. Concerns have also been raised about the potential for replacing public, vetted committees with "handpicked scientists" who may align with specific views.

As the FDA navigates these changes, industry professionals, from drug development and manufacturing professionals to those in quality systems and regulatory affairs, must remain vigilant. Understanding the evolving regulatory landscape, proactively strengthening internal quality and compliance frameworks, and upholding the highest standards of transparency will be crucial for success in this new era of drug approval.

Under Trump, FDA Seeks To Abandon Expert Reviews of New Drugs

Historical Evolution of FDA Advisory Committees

FDA Initiates Real-Time CRL Publication: What It Means for Drug Developers

Inside the Tactical Tug of War Over the Controversial Alzheimer’s Drug

PDA 2025: FDA Experts’ Proactive Strategies for Mastering 483 Responses

AI and Digital Oversight in Pharma Supply Chains: PDA Regulatory Conference Insights

Navigating Regulatory Training: Digital Transformation Strategies for a Smarter Pharma Workforce

Articles

The FDA is contemplating a shift away from using external expert advisory committees for new drug applications, a move that could significantly impact regulatory strategy, transparency, and internal quality systems. George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research, argues that these committees are redundant and time-consuming. Critics, however, warn that this could reduce public scrutiny and transparency. The potential change emphasizes the need for robust internal quality systems and proactive communication to maintain public trust and ensure compliance in the pharmaceutical industry.

This potential shift has profound implications for regulatory strategy, transparency, and internal quality systems, directly impacting the core concerns of industry professionals.

FDA Abandoning Expert Reviews: Implications for Drug Developers and Quality Professionals

PharmTech Weekly Roundup – Week of September 8, 2025

In this new PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage.

Collectively, the week’s coverage discusses critical trends and advancements in the pharmaceutical industry, primarily focusing on insights from the 

, held September 8-10 in Washington, DC. A significant theme across our conference coverage is the increasing integration of artificial intelligence (AI) into various aspects of pharmaceutical operations, including 

, emphasizing the need for robust data governance, human oversight, and regulatory compliance.

We also address the importance of quality assurance and adherence to FDA regulations, detailing 

, strengthening responses to inspection findings, and fostering a strong quality culture from leadership down. Additionally, there are discussions on 

digital transformation in workforce training

, highlighting how modern learning management systems, virtual reality, and AI can enhance practical skills and continuous learning within the industry. Check out our interview with key PDA experts who provide 

.

Outside of our PDA Regulatory Conference coverage, we present real-world data on a 

, showcasing its comparable effectiveness to traditional injections and its approval as a non-injection alternative for anaphylaxis; the European Commission's decision to 

continue allowing titanium dioxide in medicines

, despite its ban in food; and findings from a 

 of 1000 senior executives across various sectors, identifying key priorities and challenges for supply chain resilience.

Pharma embraces AI for quality, supply chain, and training; navigates FDA compliance; and develops new treatments like an epinephrine nasal spray.

Dawn over Washington - with 3 iconic monuments illuminated at sunrise: Lincoln Memorial, Washington Monument and the Capitol Building | Image Credit © mandritoiu - stock.adobe.com

FDA is emphasizing a shift from checkbox compliance to a holistic, quality systems-focused approach in pharmaceutical manufacturing. During the 

, agency officials outlined expectations for companies responding to inspectional findings, from Form FDA 483 observations to post-warning letter remediation, during the session “Sustainable CGMP Remediation Plans and Communication: FDA Updates” (1). Discussions highlighted that compliance is not merely a regulatory burden but a strategic investment that drives operational excellence and strengthens competitive advantage. These themes, along with FDA insights and compliance trends, were widely covered, as seen in articles from pharmtech.com on the conference, including "

PDA Regulatory Conference Features More than 30 FDA Experts

Glenn Wright Highlights AI, FDA Insights at 34th Annual PDA Regulatory Conference

How is FDA compliance evolving for pharmaceutical manufacturers?

FDA officials noted that compliance is inherently focused on quality, science, and patient risk, rather than being a mere paperwork exercise. The agency seeks to foster an "anti-fragile" quality organization that can emerge stronger after problems are found, whether through FDA inspections, internal audits, or other external assessments. This perspective encourages companies to view inspectional findings as a catalyst for strengthening their systems. This aligns with insights exploring how to build resilience in pharma development (2). This transformation requires continuous improvement and a recognition that quality must be built in "by design," a principle echoed in manufacturing regulations and Deming's principles of management. Strategies for a smarter pharma workforce and digital transformation for regulatory training also support continuous improvement (3).

What are FDA's expectations for post-warning letter meetings?

Milind Ganjawala, a Division Director, DDQ, OMQ, OC, CDER, FDA

, stated that a reinspection is guaranteed to occur after a warning letter and will focus on systemic fixes, not just the specific items cited in the warning letter, which are often "a very small snapshot" of potential issues. He emphasized a "holistic view" and a "quality systems improvement approach," encouraging companies with multiple facilities to apply the lessons learned across their entire organization.

To be eligible for a post-warning letter meeting, a facility must have current good manufacturing practices and an Official Action Indicated compliance status from an inspection. The facility must also be current with its fees under the Food, Drug, and Cosmetic Act or be part of a pending application if it is an active pharmaceutical ingredient facility. These meetings are generally specific to 501-type warning letters related to good manufacturing practices violations.

When requesting a meeting, companies must demonstrate "actual implementation" of corrective actions, not just plans, noted Ganjawala, who stressed that progress should be "measurable" and geared toward remediation. He explained that the meeting package should include a robust root cause analysis for each warning letter item, an impact assessment on product quality and other systems, a comprehensive Corrective and Preventive Actions plan with realistic timelines, and evidence of implementation progress. The FDA reviews these requests and typically responds within 30 days, he added.

Denial reasons for meeting requests include missing Corrective and Preventive Actions plans, insufficient documentation of actual progress, a failure to establish a broader quality systems impact, or a lack of retrospective product quality assessment, continued Ganjawala, urging firms to "plan for the long game, not the quick fix."

How can pharmaceutical firms strengthen their 483 responses?

Tara Gooen Bizjak, Associate Director, GMP and Quality Standards, OC, CDER, FDA

, highlighted that a company's response to an FDA Form 483 is critical, serving as the "first impression" of how seriously findings are taken and providing a "visual demonstration of your site’s quality culture." While responding to a 483 is optional, it is invaluable for the FDA's evaluation of an inspection case. The importance of quality culture and FDA trends was a key highlight at the conference (1).

Effective 483 responses should demonstrate a vigilant, prevention-focused approach, rooted in a strong quality system that provides "broader stability" to the organization, continued Gooen Bizjak. The response should show "proactive leadership" and embrace a comprehensive evaluation, including systemic solutions and pertinent risk assessments. She noted that "helpful elements of a response include an executive summary demonstrating leadership’s commitment to quality, comprehensive risk assessment including patient and product impact evaluation, detailed investigation reports," and a diligent root cause analysis for each observation. It should also outline a Corrective and Preventive Actions plan with realistic, measurable milestones and include effectiveness monitoring.

Common pitfalls in 483 responses include minimizing the scope of findings, offering "quick fixes" without thorough root cause analysis, proposing unrealistic timelines, underestimating resource requirements, and poor communication, according to Gooen Bizjak, who cited examples from recent warning letters in which company responses were deemed inadequate due to high defect levels, lack of evidence for analytical method equivalency, failure to identify and implement appropriate Corrective and Preventive Actions from repeated sterility investigations, and an inability to address fundamental deficiencies in the quality unit.

What are key strategies for sustained pharmaceutical compliance?

Both speakers emphasized the importance of a comprehensive approach to quality and compliance. When a facility receives a 483 or a warning letter, it should trigger an examination of other facilities within the company to ensure they are in a sustainable state of compliance. They also suggested looking at publicly available warning letters and 483s to understand potential issues that might apply to one's own operations.

To improve investigations and root cause analysis, a common deficiency cited, companies should focus on sustainable solutions rather than quick fixes. Gooen Bizjak recommended ensuring that a "well-rounded team of subject matter experts" looks at issues to minimize bias in root cause determination and incorporate diverse perspectives. This approach is crucial for effective problem-solving (4). Managing compliance risks also benefits from such a comprehensive view (5).

Regarding organizational design, the FDA expects the quality unit to be independent and not report to production management, according to the presenters. They emphasized that senior management engagement is crucial, demonstrated by their physical presence on the manufacturing floor and their commitment to allocating necessary resources, shifting the mindset of quality from a "cost center" to an "investment." Ultimately, they encouraged firms to take ownership of their quality systems and continuous improvement, rather than relying on FDA to be their quality department. This approach leads to sustained compliance excellence and builds a quality system worthy of patient trust.

Building Resilience and Precision in Pharma Development

Effectively Using Contamination Control Strategies

Manufacturer Guidelines for the Secure Destruction of Controlled Substance Pharmaceuticals

The FDA is shifting its focus from mere compliance to a holistic, quality systems-focused approach in pharmaceutical manufacturing. This involves viewing compliance as a strategic investment that enhances operational excellence and competitive advantage. The agency emphasizes building resilient quality organizations that improve after inspections and encourages a comprehensive approach to addressing inspectional findings. Post-warning letter meetings require demonstrated implementation of corrective actions, while effective responses to Form 483 should reflect a strong quality culture. Sustained compliance involves independent quality units, senior management engagement, and a focus on continuous improvement.

FDA experts at PDA 2025 urges pharma to adopt holistic quality systems, strengthening 483 responses & post-warning letter remediation for compliance excellence.

PDA 2025: FDA Experts’ Proactive Strategies for Mastering 483 Responses 

Businessman hand pressing button Training. sign on virtual screen. business Mentoring Learning Education Browsing concept | Image Credit: © NaMong Productions - stock.adobe.com

Optimizing training for performance in the pharmaceutical industry was a key theme at the PDA Regulatory Conference 2025, with discussions centered on moving beyond basic compliance to leveraging digital tools for more relevant and responsive learning. Industry experts Marc Glogovsky and Richard Jaenisch shared insights on the evolution of training methodologies and the potential of new technologies on Monday, September 8, 2025 in the session “Competency-Based Training and Digital Learning,” moderated by PharmTech editorial adivisory board member and 

 co-host Susan Schniepp, fellow, Regulatory Compliance Associates.

Why is training for performance a necessity in regulated industries?

Training is more than a checkbox; it is a legal requirement, said 

Marc Glogovsky, Business Unit Manager of Microbiology at ValSource, Inc

., who emphasized that every person involved in operations must receive job-specific, ongoing training in Good Manufacturing Practices (GMP), delivered by qualified individuals. Unfortunately, training sometimes devolves into rote exercises lacking relevance. As Glogovsky observed, employees question modules like “lockout tagout” that have little practical connection to their duties. Effective training, he stressed, ensures personnel are “fit for purpose.”

This isn’t just theoretical. In 2024, there were 27 FDA 483s citing training deficiencies among 561 total for drug products, Glogovsky noted, a trend seen year after year. “If you're not giving them the proper tools, the proper training… you’re going to get some type of half-assed response… not in line with what the [GMP] expectations are,” he stated.

What are the common challenges facing traditional training programs?

Both speakers acknowledged major obstacles in traditional training. Glogovsky cited the overwhelming number of regulations across GMP, good clinical practice, good distribution practice, etc., skill gaps caused by evolving roles, rapid tech shifts, and high employee turnover. In-person training often strains resources, leads to disengagement, and can cause “burnout” for instructors and learners alike, he added. As Glogovsky joked, “If you give me training at 10:00 on a Monday, it's going to be a good day; you give that to me at 4:59 on a Friday, good luck.”

Richard Jaenisch, Director of Education and Outreach at Open Biopharma Research and Training Institute

, echoed these points, stressing the “human factor,” noting that people switch organizations, and systems’ needs change swiftly.

How can digital transformation elevate learning management systems?

Digital learning management systems (LMSs)—from 

—are central to modernizing training. Jaenisch explained that these systems, accelerated by the COVID-19 pandemic, simplify audit readiness, allow easy tracking, and enable learning “anywhere, anytime.” Interactive features like quizzes within videos and global accessibility are advancing continuously. Micro-certifications are also becoming standard for validating workforce skills.

What roles do VR and AR play in practical skill development?

Virtual Reality (VR) and Augmented Reality (AR) transform hands-on skills training, said Glogovsky, who found VR “eye opening” for cleanroom work, letting staff see how actions alter airflow in a way impossible to replicate in person. Jaenisch described VR as invaluable for onboarding, reducing risk and costs, and supplying critical feedback on techniques like aseptic manipulation.

AR is a game-changer for “digital work instruction,” they both agreed. With AR, protocols and schematics overlay live equipment, and trainees can practice virtually using digital twins of facilities—essential for complex, unfamiliar tasks and equipment.

Is gamification an effective strategy for enhancing engagement?

Gamification applies game mechanics—points, badges, leaderboards—to increase engagement. Glogovsky noted it can “be quite engaging,” turning even reticent operators competitive. Yet Jaenisch cautioned that gamification doesn’t motivate everyone, joking that “Some people don't need no stinking badges” and explaining that misapplied gamification may favor “addiction over utility,” distracting from true learning. Extrinsic motivators like financial incentives and time off often work better, and gamified elements need purposeful, personalized integration.

How can generative AI revolutionize training content and delivery?

Generative artificial intelligence (AI) is reshaping workforce training, said Jaenisch, who called it one of the “two big fundamental changes” in digital learning. Key AI applications that he noted include:

Content summaries: AI rewrites standard operatice procedures (SOPs) or training content for clarity and accessibility, especially for non-native English speakers.

Quiz generation/assessment: Automated, adaptive quizzes measure understanding instantly.

Personalized learning: AI fine-tunes curricula to individual needs.

24/7 feedback: Intelligent tutoring systems can support learners in real-time, offering tailored guidance.

At Open Biopharma, digital interactive SOPs use AI to analyze quiz answers deeply, giving specific feedback, even for partially correct responses, and tracking progress in detail. Glogovsky also noted AI’s usefulness for generating training visuals and materials.

What are the barriers to adopting new digital training tools?

Despite digital potential, adoption is challenging, according to Jaenisch, who pointed to the high costs of LMS and AI tools—an LMS can run tens of thousands of dollars, while sophisticated generative AI can cost hundreds of thousands to millions, he added. Implementing these systems demands robust data infrastructure, regulatory clarity (often lacking or inconsistent between the US and EU), and organizational readiness for change.

What does the future hold for biomanufacturing training?

Looking ahead, biomanufacturing training is moving toward a “unified, intelligent learning ecosystem.” Centralized LMS platforms, integrated VR/AR for skills building, carefully applied gamification, and micro-certifications will define future models. Overcoming obstacles hinges on phased pilots, commitment to compliance and talent growth, security by design, and ongoing measurement.

A digital-first mindset—rooted in compliance, ethics, and relentless improvement—will grow a skilled workforce. Glogovsky advocated, “I would like to see training done every day—don’t just slam someone with 75 days of training into one week.” Breaking training into daily sessions supports mentoring, sharing, and transparency. Jaenisch’s group plans daily 20-minute sessions with generative AI, enabling continuous learning and real-time progress tracking for both individuals and teams.

Optimizing training in the pharmaceutical industry is crucial for compliance and performance, with digital tools enhancing learning experiences. Industry experts emphasize the need for job-specific, ongoing training to meet Good Manufacturing Practices (GMP) standards. Traditional training faces challenges like resource strain and disengagement, while digital learning management systems (LMSs) offer flexibility and audit readiness. Virtual Reality (VR) and Augmented Reality (AR) enhance practical skills training, and generative AI personalizes learning. Despite high costs and regulatory challenges, a digital-first approach promises a unified, intelligent learning ecosystem for biomanufacturing.