Smart Biotech Scientist Podcast – Master Bioprocess Development

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Podcast

Smart Biotech Scientist Podcast – Master Bioprocess Development

Ever wondered what it takes to build a large-scale biotech facility?

Alfredo Martínez Mogarra, Chief Operations Manager at VIVEbiotech and CSO of the Biotech Academy in Rome, spills the secrets in the latest podcast episode n.79 of Smart Biotech Scientist Podcast – Master Bioprocess Development (bruehlmann-consulting.com)

With 30+ years of experience, Alfredo shares game-changing insights on biotech facility design and scale-up.

Highlights:
✓ Discover key factors for efficient facility design.
✓ Learn risk mitigation strategies for process scale-up.
✓ Uncover tips for successful interdisciplinary collaboration.

Whether you’re a scientist, engineer, or industry pro, this episode is your ticket to leveling up your bioprocessing skills.

Ready to think holistically about biotech facility design?

Tune in now and transform your approach to biotech manufacturing!

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The Importance of Gamification in Professional Training

Category
Blog

The Importance of Gamification in Professional Training

In today’s rapidly evolving professional landscape, organizations are increasingly turning to innovative methods to enhance employee training and development. Among these methods, gamification stands out as a particularly effective and engaging approach. By incorporating game-like elements into training programs, businesses can significantly boost employee motivation,
improve knowledge retention, and foster a more dynamic learning environment.

Understanding Gamification
Gamification involves integrating game mechanics such as points, levels, challenges, and rewards—into non-game contexts. In the realm of professional training, this means designing training modules that incorporate these elements to make learning more interactive and enjoyable. The primary goal is to tap into the natural human inclination towards competition and achievement, thereby making the training process more compelling.

Enhancing Motivation and Engagement
One of the most significant benefits of gamification in professional training is its ability to enhance motivation and engagement. Traditional training methods often suffer from low engagement rates, with employees viewing them as tedious and uninspiring. Gamification transforms this experience by introducing elements of fun and competition. For instance, leaderboards and achievement badges can motivate employees to actively participate and strive for excellence.

Improving Knowledge Retention
Research has shown that gamification can lead to better knowledge retention. The interactive nature of gamified training programs encourages active learning, which is more effective than passive absorption of information. By engaging with the material in a hands-on manner, employees are more likely to remember and apply what they have learned. Additionally, the use of quizzes and challenges can reinforce key concepts, ensuring that knowledge is retained over the long term.

Fostering Collaboration and Teamwork
Gamification can also promote collaboration and teamwork among employees. Many gamified training programs include team-based challenges that require employees to work together to
achieve common goals. This not only helps in building a sense of camaraderie but also enhances communication and problem-solving skills. In a gamified environment, employees can learn from one another, share insights, and develop a stronger sense of community.

Providing Immediate Feedback
Another critical advantage of gamification is the provision of immediate feedback. In a gamified training program, employees receive instant feedback on their performance, which helps them
identify areas for improvement and adjust their strategies accordingly. This real-time feedback loop is crucial for effective learning, as it allows employees to correct mistakes and reinforce positive behaviors promptly.

Customizing Learning Experiences
Gamification enables the customization of learning experiences to meet the needs of individual employees. By incorporating adaptive learning technologies, gamified training programs can tailor
content to match each employee’s skill level and learning pace. This personalized approach ensures that employees are neither bored with material that is too easy nor overwhelmed by content that is too difficult. As a result, each employee can progress at their own pace, leading to more effective and satisfying learning outcomes.

Measuring Training Effectiveness
Gamified training programs also offer robust tools for measuring training effectiveness. Through tracking metrics such as completion rates, scores, and levels achieved, organizations can gain
valuable insights into how well employees are absorbing the material and which areas may need further attention. This data-driven approach allows for continuous improvement of training programs, ensuring that they remain relevant and effective.

Encouraging a Growth Mindset
Lastly, gamification encourages a growth mindset among employees. By framing challenges as opportunities for growth and learning, gamified training programs help employees develop resilience and a willingness to embrace new challenges. This mindset is essential in today’s fast-paced business environment, where adaptability and continuous learning are key to success.

Conclusion
The integration of gamification into professional training represents a powerful shift towards more engaging, effective, and personalized learning experiences. By leveraging the motivational power
of game mechanics, organizations can enhance employee engagement, improve knowledge retention, and foster a collaborative and growth-oriented workplace culture. As businesses continue to navigate the complexities of the modern world, gamification will undoubtedly play a crucial role in shaping the future of professional development.

Dr. Leonardo Sibilio
CEO Biotech Academy in Rome

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07.05.2024 Tavola rotonda sul Biotech tra Italia e America Latina

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Events

07.05.2024 Tavola rotonda sul Biotech tra Italia e America Latina

Ieri, il nostro Presidente, Dr. Valerio Branchi, ha inaugurato assieme al Segretario Generale Min. Antonella Cavallari e l’Ambasciatore del Cile S.E. Ennio Vivaldi, presso l’Istituto Italo-Latinoamericano IILA-Organizzazione Internazionale Italo-latino americana la prima tavola rotonda sul Biotech tra Italia e America Latina, evento realizzato in collaborazione con la , che ha permesso di esplorare le nuove frontiere della biotecnologia e delle scienze della vita, mettendo in luce le prospettive e le opportunità per lo sviluppo e la formazione nel settore biotech. È stata un’occasione preziosa per favorire lo scambio di conoscenze, esperienze e opportunità di collaborazione tra accademici, ricercatori, professionisti, politici e diplomatici di rilievo internazionale, grazie ai due tavoli di lavoro magistralmente diretti dal Moderatore, Dr. Gianfranco Anzini, uno tra i più importanti documentaristi scientifici del panorama televisivo italiano, con la partecipazione del Cons. Basilio Antonio Toth della DGPS del Ministero degli Affari Esteri e della Cooperazione Internazionale, della Direttrice Generale, Dr.ssa Maria Cristina Porta, della Fondazione ENEA Tech e Biomedical, del CEO della Biotech Academy in Rome, Dr. Leonardo Sibilio, del Presidente della Fondazione dell’Università Campus Bio-Medico di Roma, Dr. Alessandro Pernigo e alcuni importanti laboratori bio farmaceutici, come mAbxience in collegamento dall’Argentina con il Dr. Lucas Filgueira Risso e il CEO di Takis Biotech Dr. Luigi Aurisicchio e la Presidente dell’IBI – Istituto Biochimico Italiano Giovanni Lorenzini S.p.a. Dr.ssa Camilla Borghese Kevenhüller, in sala.

“L’evento si è proposto di essere un’importante piattaforma di dialogo e collaborazione tra Italia e America Latina nel campo della biotecnologia e delle scienze della vita, favorendo lo scambio di conoscenze, esperienze e opportunità di sviluppo e formazione nel settore biotech”, ha dichiarato il Segretario Tecnico Scientifico, Dr.ssa Tatiana Ribeiro Viana riscuotendo un enorme successo e interesse con la partecipazione di oltre 20 alti funzionari e Ambasciatori dei paesi membri, una importante presenza di rappresentanti del mondo biotech e farmaceutico internazionale e più di 60 collegamenti via zoom da tutti i paesi dell’America Latina.

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The importance of STEM in Biotech

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Blog

The importance of STEM in Biotech

In the rapidly evolving landscape of modern science and technology, the role of STEM (Science, Technology, Engineering, and Mathematics) in biotechnology cannot be overstated. Biotechnology, a multidisciplinary field that merges biology with technology, has become a cornerstone in addressing some of the most pressing challenges of our time, from healthcare and agriculture to environmental sustainability and beyond. Here’s why STEM is crucial in shaping the future of biotech:

1. Innovation and Discovery

STEM disciplines provide the foundational knowledge and tools required for groundbreaking discoveries in biotechnology. Advances in molecular biology, genetics, and computational biology have paved the way for innovative therapies, diagnostic tools, and biotechnological processes that were once considered science fiction.

2. Interdisciplinary Approach

Biotechnology is inherently interdisciplinary, drawing upon principles from biology, chemistry, physics, and engineering. A strong STEM background enables professionals to approach complex problems from multiple perspectives, fostering creativity and collaboration across different fields.

3. Technological Advancements

The integration of technology in biotech has led to the development of high-throughput sequencing, CRISPR gene editing, synthetic biology, and advanced imaging techniques, revolutionizing our understanding of biological systems and accelerating the pace of scientific discovery.

4. Addressing Global Challenges

STEM-driven biotechnological innovations have the potential to address some of the most pressing global challenges, such as the development of sustainable biofuels, the eradication of infectious diseases, the production of drought-resistant crops, and personalized medicine tailored to individual genetic profiles.

5. Economic Growth and Job Creation

Investments in STEM education and research are essential for driving economic growth and job creation in the biotech sector. As biotechnology continues to expand, there is a growing demand for skilled professionals with expertise in STEM fields, ranging from research scientists and engineers to data analysts and bioinformaticians.

Conclusion
In conclusion, STEM plays a pivotal role in advancing the field of biotechnology, driving innovation, fostering interdisciplinary collaboration, and addressing global challenges. As we continue to unlock the mysteries of life at the molecular level, the importance of STEM in shaping the future of biotech will only continue to grow. Therefore, it is crucial to invest in STEM Education and research.

Dr. Valerio Branchi
President of Biotech Academy in Rome

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Biopharmaceuticals Transforming Healthcare with Innovative Therapies

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Blog

Biopharmaceuticals Transforming Healthcare with Innovative Therapies

In the dynamic landscape of modern medicine, biopharmaceuticals stand as a beacon of hope, offering revolutionary treatments that challenge traditional healthcare norms. These innovative therapies, derived from biological sources, are reshaping the way we approach various diseases and medical conditions. From personalized cancer treatments to gene therapies targeting rare genetic disorders, biopharmaceuticals are at the forefront of medical breakthroughs, promising a future where previously incurable diseases may become manageable or even eradicated.

Understanding Biopharmaceuticals
Biopharmaceuticals, also known as biologics, are medicinal products derived from biological sources such as living organisms, cells, tissues, or genetic material. Unlike traditional pharmaceuticals synthesized through chemical processes, biopharmaceuticals harness the power of living organisms to produce therapeutic agents. This unique approach allows for the creation of highly targeted and effective treatments with fewer side effects compared to conventional drugs.

The Rise of Personalized Medicine

One of the most profound impacts of biopharmaceuticals is their role in personalized medicine. By leveraging advancements in genomics and molecular biology, biopharmaceutical companies can develop treatments tailored to individual patients’ genetic makeup. This targeted approach not only improves treatment efficacy but also minimizes adverse reactions, leading to better patient outcomes.

In the field of oncology, personalized cancer therapies have revolutionized treatment strategies. Biopharmaceuticals such as monoclonal antibodies and immune checkpoint inhibitors can precisely target cancer cells while sparing healthy tissue, offering new hope to patients with advanced or treatment-resistant cancers. Additionally, companion diagnostics play a crucial role in identifying patients who are most likely to benefit from these therapies, further optimizing treatment selection.

Gene Therapies: A New Frontier

Gene therapy, a subset of biopharmaceuticals, holds tremendous promise for treating genetic disorders by correcting faulty genes or introducing functional ones into the body. Recent breakthroughs in gene editing technologies, such as CRISPR-Cas9, have accelerated the development of gene therapies for a wide range of conditions, including rare genetic diseases like cystic fibrosis and sickle cell anemia.

These innovative therapies have the potential to transform the lives of patients with previously untreatable genetic disorders, offering the prospect of long-term symptom relief or even cures. While gene therapy is still in its infancy, ongoing research and clinical trials continue to push the boundaries of what is possible, bringing us closer to a future where genetic diseases may become a thing of the past.

Challenges and Opportunities

Despite the tremendous potential of biopharmaceuticals, their development and adoption are not without challenges. The complex nature of biological systems poses unique hurdles in drug discovery, manufacturing, and regulatory approval. Additionally, the high cost of biopharmaceuticals presents accessibility barriers for many patients, raising questions about equitable healthcare distribution.

However, amidst these challenges lie opportunities for innovation and collaboration. Advances in biotechnology, data analytics, and artificial intelligence are driving efficiencies in drug development and manufacturing, potentially reducing costs and accelerating time to market. Furthermore, partnerships between industry, academia, and regulatory agencies can foster a supportive ecosystem for advancing biopharmaceutical research and ensuring patient access to life-saving therapies.

Conclusion

Biopharmaceuticals are transforming healthcare as we know it, offering novel therapies that address unmet medical needs and improve patient outcomes. From personalized cancer treatments to groundbreaking gene therapies, these innovative interventions hold the promise of a brighter, healthier future for individuals around the globe. While challenges remain, continued investment in biopharmaceutical research and development, coupled with collaborative efforts across the healthcare ecosystem, will be essential in realizing the full potential of these transformative therapies and ensuring they reach those who need them most.

Dr. Leonardo Sibilio
CEO Biotech Academy in Rome

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Why is it important to learn GMP training through virtual reality

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Blog

Why is it important to learn GMP training through virtual reality

Why is it important to learn GMP training through virtual reality?
GMP (Good Manufacturing Practice) training is crucial for professionals working in industries like pharmaceuticals, biotechnology, food manufacturing, and others where the quality and safety of products are paramount. Incorporating Virtual Reality (VR) into GMP training offers several important advantages:

1. Realistic Simulation: VR allows trainees to experience realistic, immersive simulations of manufacturing processes, equipment operation, and quality control procedures. This hands-on experience can be more effective than traditional classroom-based or online training methods.

2. Safety Training: In industries where safety is a major concern, VR can provide a safe environment for trainees to practice procedures and protocols without the risk of injury or damage to equipment.

3. Cost-Effective: Virtual training can reduce the costs associated with traditional training methods, such as travel, equipment setup, and materials. Once the VR training program is developed, it can be easily distributed to multiple trainees without additional costs.

4. Consistency: VR training ensures that all trainees receive the same high-quality, consistent instruction, reducing variability in training outcomes.

5. Engagement and Retention: VR can increase trainee engagement by providing an interactive and immersive learning experience. Studies have shown that immersive learning environments can improve retention and knowledge transfer compared to traditional training methods.

6. Flexibility: VR training can be accessed remotely, allowing trainees to learn at their own pace and on their own schedule. This flexibility can be particularly beneficial for organizations with remote or distributed teams.

7. Adaptability: VR training programs can be easily updated and adapted to incorporate new regulations, technologies, or best practices without the need for extensive redevelopment.

8. Assessment and Feedback: VR platforms can incorporate real-time assessment and feedback mechanisms, allowing trainers to monitor trainee progress and identify areas for improvement more effectively.

9. Skill Development: VR can be used to simulate complex tasks and scenarios that are difficult to replicate in a traditional training environment, allowing trainees to develop and hone their skills in a risk-free setting.

In summary, learning GMP training through Virtual Reality offers a more engaging, realistic, and effective way to train professionals in the principles and practices of Good Manufacturing Practice. It can improve safety, reduce costs, enhance learning outcomes, and provide organizations with a more flexible and adaptable training solution.

Are you ready to revolutionize your biotech career? The Biotech Academy in Rome proudly presents the cutting-edge “GMP Training by Virtual Reality” course!

• Course Highlights
• Introduction to GMP Principles
• Cleanroom and Aseptic Techniques
• Quality Control and Assurance
• Equipment and Facility Maintenance
• Documentation and Compliance
• Realistic Virtual Labs

Who should attend?
Scientists, researchers, lab technicians, and students looking to enhance knowledge of GMP Guidelines or to be ready for the next career step.

Dr. Leonardo Sibilio
CEO Biotech Academy in Rome

 

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CRISPR Technology The Next Frontier in Gene Editing

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Blog

CRISPR Technology The Next Frontier in Gene Editing

In the realm of genetics, a groundbreaking innovation has emerged, poised to revolutionize the way we understand and manipulate the building blocks of life: CRISPR technology. This revolutionary tool, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, has unlocked unprecedented potential for precise gene editing, offering scientists the ability to alter DNA with levels of accuracy and efficiency previously unimaginable. As we delve into the depths of this cutting-edge technology, it becomes increasingly evident that CRISPR represents the next frontier in gene editing, holding immense promise for a myriad of applications across various fields.

At its core, CRISPR technology harnesses the natural defense mechanism found in bacteria against viral infections. This system consists of two key components: the Cas9 enzyme, which acts as molecular scissors, and a guide RNA molecule, which directs Cas9 to the targeted sequence of DNA. Once the Cas9 enzyme is guided to the desired location, it can precisely cut the DNA, allowing for the insertion, deletion, or modification of specific genes.

One of the most significant advantages of CRISPR technology lies in its versatility and accessibility. Unlike previous gene editing techniques, which were often cumbersome and time-consuming, CRISPR offers a streamlined approach that is relatively simple and cost-effective. This accessibility has democratized gene editing, empowering researchers around the world to explore new frontiers in genetics.

The potential applications of CRISPR technology are vast and varied, spanning fields such as medicine, agriculture, and biotechnology. In medicine, CRISPR holds the promise of revolutionizing the treatment of genetic disorders, offering the potential to correct faulty genes responsible for conditions ranging from cystic fibrosis to sickle cell anemia. Additionally, CRISPR-based therapies could pave the way for personalized medicine, tailored to the unique genetic makeup of individual patients.

In agriculture, CRISPR has the potential to transform crop breeding, enabling scientists to develop crops with enhanced yields, nutritional profiles, and resistance to pests and diseases. By precisely editing the genes responsible for desirable traits, researchers can accelerate the breeding process, leading to more resilient and sustainable agricultural practices.

Beyond medicine and agriculture, CRISPR technology is opening new avenues for scientific discovery and innovation. Researchers are exploring its potential in creating disease-resistant livestock, engineering microbial organisms for environmental remediation, and even resurrecting extinct species through genetic manipulation.

However, along with its immense promise, CRISPR technology also raises ethical and societal considerations that must be carefully addressed. The ability to manipulate the fundamental building blocks of life raises questions about the potential misuse of this technology, as well as concerns about unintended consequences and unforeseen risks. As we continue to unlock the full potential of CRISPR, it is essential that we proceed with caution and thoughtfully consider the ethical implications of our actions.

In conclusion, CRISPR technology represents a paradigm shift in our ability to manipulate the genetic code of living organisms. Its unprecedented precision, efficiency, and accessibility have positioned it as the next frontier in gene editing, with far-reaching implications for medicine, agriculture, and beyond. As we navigate this exciting new era of genetic engineering, it is crucial that we approach it with both curiosity and caution, ensuring that the benefits of CRISPR are realized in a responsible and ethical manner.

Dr. Leonardo Sibilio
CEO Biotech Academy in Rome

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Tips for Students: How to prepare careers in Biotech

Category
Tips

Tips for Students: How to prepare careers in Biotech

Preparing for a career in biotech requires a combination of academic preparation, practical skills development, networking, and staying abreast of industry trends.

Here are some tips for students interested in pursuing careers in biotech:

Get a Strong Educational Foundation: Focus on obtaining a solid education in relevant fields such as biology, chemistry, biochemistry, molecular biology, or biotechnology. Pursue advanced degrees if possible, such as a Master’s or Ph.D., depending on your career goals.

Gain Hands-on Experience: Seek out internships, co-op programs, or research opportunities in biotech companies, academic labs, or research institutions. Hands on experience is invaluable in the biotech industry and can help you develop practical skills and build a network of professionals.

Stay Updated on Industry Trends: Follow industry news, read scientific journals, and attend conferences or seminars to stay informed about the latest developments and trends in biotechnology. This will help you understand the current landscape and anticipate future opportunities and challenges.

Develop Technical Skills: Hone your laboratory skills, including techniques such as PCR, cell culture, protein purification, genetic engineering, and bioinformatics. Familiarize yourself with relevant software and instrumentation used in biotech research and development.

Build a Professional Network: Connect with professionals in the biotech industry through networking events, online forums, and professional organizations such as the Biotechnology Innovation Organization (BIO) or local biotech associations. Building relationships with mentors and peers can provide valuable insights and opportunities.

Enhance Soft Skills: In addition to technical expertise, cultivate soft skills such as communication, teamwork, problem-solving, and adaptability. These skills are essential for success in collaborative research environments and in interacting with colleagues, clients, and stakeholders.

Gain Business Acumen: Understand the business side of biotechnology, including regulatory requirements, intellectual property  considerations, project management, and commercialization strategies. Courses or workshops in biotech entrepreneurship or business development can be beneficial.

Seek Mentorship and Guidance: Find mentors within the biotech industry who can offer advice, guidance, and support as you navigate your career path. Learn from their experiences and seek opportunities for mentorship and professional development.

Stay Flexible and Open-Minded: The biotech industry is dynamic and constantly evolving, so be prepared to adapt to changing circumstances and opportunities. Keep an open mind to exploring different career paths within biotech and be willing to take on new challenges and experiences.

Leonardo Sibilio
CEO of Biotech Academy in Rome  

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What happened to synthetic DNA?

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Blog

What happened to synthetic DNA?

Not long ago, the synthetic DNA seemed to have a brilliant future as potential replacement of the plasmid DNA used for gene therapies.

The increasing number of gen therapy projects in-progress, boosted by the success of different treatments for its commercial distribution, depicted a promising landscape for smart technologies that, involving much lower volumes and apparently less operational complexity than plasmid production, clearly identified a business opportunity.

From 2019, a few initiatives were added to the existing ones, offering a product that was available for customer quite straight forward, avoiding the queue necessary to obtain good plasmid from a relevant supplier.

Not only, due to its simplicity, the synthetic DNA promised to be safer, free of undesired sequences and better characterized than plasmids. Some of these new companies has put the synthetic DNA in clinical trials.

However, five years later, all the energy exhibited by synthetic DNA companies seems to have evaporated, with some exception. What has happened? Why this lost of interest or this lost of target hitting by those developers/manufacturers of this new technology? It is true that the market environment has not been the most favorable for a sector which is very much dependant on finance rounds, the Russia-Ukranie war and the endless problems in international commerce did not help, but the product is still good. Analytical results are not an opinion and they clearly show that synthetic DNA is free -or almost- of bacterial sequences. The practice demonstrates that huge mounts of synthetic DNA can be obtained in a surprisingly short periods of time, where is then the problem? In my opinion there are a few points that may explain this decay of the synthetic DNA:

1. There are products in the market produced with plasmid, which means that plasmid is good enough for regulators. Against such a business card, you need to do an extraordinary effort to defend a new product and make it attractive enough to make therapy developers assume the risk involved in the novelty.

2. When the product is new, the manufacturer needs to assess the customers on the use of this product closely and patiently, invest time and resources and go side by side with the therapy developer to facilitate the risk mitigation.

3. There is a regulatory front that cannot be ignored, where the simplicity of the synthetic DNA should have a clear advantage versus the plasmid. Have the manufacturers of synthetic DNA profited of this potential?

Finally, there is a niche in my opinion waiting for the synthetic DNA, although is not clear how long it may last. I am talking about the association of synthetic DNA with non-viral vectors, another emerging technology. Both together could make a brilliant solution of the synthetic biology applied to gene therapies, but compromised investors, strong determination and clarity of ideas will be necessary. Do they exist?

Alfredo Martínez Mogarra
CSO of Biotech Academy in Rome  

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The level of manufacturing quality and the matrioskas

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Blog

The level of manufacturing quality and the matrioskas

When we design a manufacturing process, we absolutely need to pay attention to the quality of our product. The quality is built from different sources and has to be present from the earliest pahses of our development process.

Let’s keep a quick view of some aspects seriously impacting the product quality:

  • Cell line: We need to use a very well identified and characterized cell line. This cell line has to be controlled as part of the process development to ensure that the product will be the same all the time.
  • Process components: It is necessary to know the origin and the procedures to obtain the different elements entering in our manufacturing process, making sure that we control its variability and specifications.
  • Utilities: Air and other gases, process water, steam… All utiiities must be compliant with certain regulations, all well indicated in different industry guidelines. The same situation applies to process equipment, consumables, classification of areas and all elements involved in the manufacturing of a biological molecule intended for therapeutic use.

Quality means a relevant part of the investment budget. Just the validation of a new manufacturing site takes usually 15% of the construction and equipment acquisition budget, meaning that if we build a 20 million facility to produce biosimilars, as an example, we need to add three more million to get it validated. Neither negligible are the sums that we are going to spend in the validation of the process and analytical methods. The validation of a manufacturing process will take no less than 2 to 4 million to which we have to add the money we will spend in the PPQ runs.

But what I wanted to underline today is how we manage the “hardware” around our process, the number and kind of suites for manufacturing, the quality of components and the level of demand that we are going to impose to our process.

The whole thing has a clear and well identified origin: patient’s safety. This is a red-line that we cannot trespass at all and this is the only real conditionant for the elements making part of our process and facility. In this sense, quality is like a set of russian dolls, so called “matrioskas”. These dolls are all equal to each other but for their size. There is a smallest one which enters in other slightly bigger, this in another one still bigger and so on, until reaching the biggest. Now let’s look to our quality set of measures as if they were russian dolls. The biggest one, the largest matrioska, is the quality that we apply to the manufacturing of a parenteral drug product. This product goes directly to patient’s body and, because of this, any little mistake can be fatal; therefore any precaution is welcome and any expense is assumable. As long as we move to the inside of the matrioska set, we reduce the level of demand of our quality procedures or, better said, we go to less demanding quality standards. Let’s consider this example to illustrate the situation: if we fill vials to inject into a patient, we need a class A surrounded by a class B environment to secure sterility; to make a cell passage during the production we just need a class A in a class C or D, because the biggest disaster that we can produce is the contamination of the next culture stage, which is usually an assumable risk. Did I say risk? Yes, I did. Risk assessment is the key instrument that will allow us to establish the level of demand that we need in the design of our facility.

In recent times I am observing a trend to overreact in terms of quality in facilities dedicated to new therapies. Declare a cell culture process “sterile” is not helping any patient, instead, it is incredibly complicating the operation and making the product more expensive and therefore, of more difficult access to patients. It is in the duties of quality officers and regulators to find the proper compromise between quality and cost, secure patients safety and not making the products harder to obtain by the patients population.

Alfredo Martínez Mogarra
CSO of Biotechnology Academy in Rome  

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