Tips for Students: How to prepare careers in Biotech

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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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