BIOTECHNOLOGY DEVELOPMENT UNIT

Development of biologics

We aim to increase the availability of low-cost, high quality biologics through transferring technologies to our partners in Member States.

BIOTECHNOLOGY
DEVELOPMENT UNIT

Development of biologics

We aim to increase the availability of low-cost, high quality biologics through transferring technologies to our partners in Member States.

Technologies

Services

Pipeline

Technologies
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Services
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Pipeline
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Our team of specialists provide training in upstream and downstream operations together with quality control analysis of biologics in accordance with European Pharmacopoeia monographs.

LATEST UPDATES

Science & Society

8th Annual International Remote Conference

Free Online Registration: www.beyondsciences.org/conference2023

ICGEB The Goals of Science

Here is the fifth episode of ICGEB The Goals of Science. This episode tells the story of ICGEB’s commitment to health and well-being for all.

Medicines are a great achievement for humankind. Today we have medicines to treat many diseases, but these are not always available to everyone in the world. Can science help provide patients around the world with wider and cheaper access to innovative medicines?

Natasa Skoko is Group Leader of Biotechnology Development at ICGEB in Trieste and focuses her research activity on biopharmaceutical development. Her team studies production strategies for biosimilars, biological drugs developed from commercial products whose patents have expired. The aim is not only to produce drugs in a new way but to increase the know-how and capabilities of the pharmaceutical industries in ICGEB Member States.

This story recounts how ICGEB’s scientific research can improve healthcare and therapies.

BDU automation cell clones screening strategy

Screening mammalian cell populations for high and stable producing clones is a key rate-limiting step in the development of biotherapeutics such as Monoclonal Antibodies. 

The BDU adopted an automation for high-throughput selection of clones with extracellularly secreted proteins in semi-solid media using colony picker Clonepix2.

Drug_Target_Review

Drug Target Review

Episode 7 – Cell line development with Dr Natasa Skoko, ICGEB & Dr Hugh Graham, MacroGenics

New pharma-compliant labs at ICGEB

With a 3 million euros grant from the Friuli Venezia Giulia region in Italy, ICGEB constructed a new pharma-compliant laboratory for biosimilars development.

Fully equipped laboratory comprising 215m2 of clean rooms for the following processes:

  • Mammalian cell line development facility
  • Upstream process Mammalian cell lines
  • Upstream process Microbial
  • Downstream process
  • Polymer preparation and protein-polymer conjugation process
  • Quality Control of biosimilars (GMP)

Technology transfer – How does it work?

We have developed technologies which are efficient, good value and simple to use.

We can provide you with comprehensive and fast in house or online training packages.

The Technology Transfer Agreement with you allows for a period of training (either video-based or in our laboratories), the supply of material and protocols for the production, purification and quality control of a specific biosimilar. Our ICGEB scientists are available to offer you further technical assistance in loco while reproducing the processes on your premises.

Available technologies

ICGEB has developed research grade strains, protocols & quality control testing in line with the European Pharmacopeia for the following:

Available technologies

ICGEB has developed research grade strains, protocols & quality control testing in line with the European Pharmacopeia for the following:

Bacterial
platform

Granulocyte colony stimulating factor and Pegylated GCSF
Interferon alfa 2a and Pegylated IFN alfa 2a
Interferon beta 1b

Mammalian cell
platform

Erythropoietin and Pegylated EPO
Interferon beta 1a and Pegylated IFN beta 1a

Yeast
platform

Human growth hormone
Short and long-lasting insulins

Explore our services

We cover a broad range of services in biopharmaceutical drug development.

Cell line development

Upstream processing

Downstream processing

Linkers chemistry

Quality Control of biologics

Biotech Development at ICGEB -testimonials from our Member States

Natasa Skoko heads Biotechnology Development at ICGEB Trieste. Here, she presents feedback from technology transfer training for the production of biotherapeutic products undertaken in her lab, underpinning the great opportunity offered to our Member States.

“It was a very happy and fruitful time we spent studying in ICGEB. The team made a complete and detailed training plan for us and conducted in-depth training on strain, fermentation, purification, activator synthesis and protein modification. Based on this, we acquired a new understanding of the whole project, and this is very helpful for the smooth development of our own projects. Thank you very much and your members, you are really a professional and efficient team.”

Zhenjun – Chinese training team

“In my experience, the most efficient way to acquire know-how is from the actual scientists who developed the methods. Their insights and the interesting discussions that took place were of great help and they continue to be relevant as we move forward with the process development in our institution. I recommend to any interested party to invest the time at the ICGEB for technology transfer as it would give your scientists a head start. I am particularly thankful for the transparency shown by the team when answering all our questions”

ZIsaac – Italian training team

“I have been involved twice in the technology transfer programme at ICGEB. I love the scientific atmosphere there. All the process yields that were claimed by them were correct or lower than we achieved during the course. At the end of the training, we were able to completely repeat the processes and we could successfully launch our biopharmaceutical products on the Iranian market. I believe that working together will help to make a better world providing more biosimilar therapeutics to patients.”

Hossein – Iranian training team

“It was a great experience: a well-structured course; very good time management, support throughout the learning process and the lab work. The team was highly qualified, supportive, skillful, easily reframing tricky and unexpected situations. The lab was very well equipped, we had the chance to learn how to troubleshoot and to overcome possible difficulties. The protocol provided us all the information we needed to make sure that we get the best results. This was a totally engaging training. The team created an environment where we were able to learn from one another and which will give us new business opportunities.”

Alexandrina – Moldovan training team

“I undertook technology transfers for a couple of blockbuster biosimilars from ICGEB to a Turkish company under the guidance of Dr. Natasa Skoko. Her team was really very sharp, intelligent with high biotechnology skills and expertise in the area of Research, Technology Development and Technology Transfer. Their services are really excellent.”

Gnanaprakasam – Turkish training team