> GENIBET BIOPHARMACEUTICALS S.A

PROVIDING TAILORED SOLUTIONS TO TURN IDEAS INTO TOMORROW’S MEDICINES

HISTORY

Founded in 2006, as a spin-off company from iBET (a private non-profit research-intensive organization in Biotechnology and Life Sciences), GenIbet was the 1st Contract Development Manufacturing Organization (CDMO), established in Portugal, to supply Biopharmaceuticals for Clinical Trials.

GenIbet was the 1st Portuguese company to obtain a Good Manufacturing Practices (GMP) certification, recognized by the European Medicines Agency, to produce Biological Investigational Medicinal Products (IMPs).

MISSION
GenIbet’s mission is to manufacture safe and reliable breakthrough products to support worldwide customers on building the therapies of the future. We offer a unique combination of strict GMP compliance with troubleshooting/problem solving approach, which is crucial for early-stage product development and a tailored solution for each specific product.

FACILITIES and GMP CERTIFICATION
GenIbet’s Manufacturing Facility is located at iBET’s Late Stage R&D and Bioproduction Unit Building, at INIAV campus. GenIbet has three independent Biological Safety Level 2 (BSL2) manufacturing units, as well as direct support areas like a Tech Transfer Laboratory, Quality Control, Weighing and Preparation Rooms and Warehouses. With in-house fill and finish capabilities, supported by highly qualified personnel and stateof the art equipment, GenIbet can provide its clients with the opportunity to go from bench to clinic in one single facility.

GenIbet facility is routinely inspected by the local Portuguese Regulatory Authority – Infarmed and holds a Manufacturing Authorization for biopharmaceuticals production and manufacture of Biological Investigational Medicinal Products (IMPs). Over the last 10 years GenIbet has established a Robust Quality System which has been audited by more than 30 clients/partners, such as Astra Zeneca, Alexion, PPD, Merck, GSK and Novartis, without any critical observations.

SERVICES OFFERED
GenIbet expertise covers a broad spectra of Biopharmaceuticals development and manufacturing, including biological banks of mammalian and insect cells, bacteria, yeasts and virus, Cell and Gene Therapy products, Live Microbial Products, Recombinant proteins, RNA and Vaccines.

As a Contract Manufacturing Organization providing materials for early Clinical Trials, GenIbet participates in several E.U. funded R&D projects, keeping up to the date with the most recent trends and technologies. The ability to quickly adopt, adapt and use these technologies, mastered by GenIbet, plays a pivotal role on the interface from R&D to GMP manufacturing.

With a team of more than 50 highly qualified professionals, GenIbet supports its customers on the development and manufacturing of unique novel products covering a wide range of technologies. For many of these products there are no established manufacturing platforms or analytical tools and there are many regulatory unknowns. The knowledge development in the scope of international R&D Projects combined with our GMP manufacturing excellence and compliance enables providing high quality solutions recognized and acknowledged by our clients and partners.

Close engagement with our clients on each project and establishment of a common understanding on potential problems and bottlenecks is the cornerstone for high quality and personalized customer service.

TRACK RECORD
GenIbet´s launching partner was the Novartis Institute for Global Health (NVGH), now GSK Institute for Global Health, with whom GenIbet collaborated on the development and manufacturing of a Typhoid Fever Vaccine, transferred to India in 2010 that ultimately led to the approval of this new medicine on the Indian Market in 2020. Other relevant partnership includes the development and manufacturing of a new veterinary vaccine against leishmaniasis, which was transferred from GenIbet to the commercial partner in 2011 and was approved by the European Medicine Agency in 2016.

GenIbet’s experience with other innovative biological medicines and advanced therapy medicinal products includes the Process Development and GMP manufacturing of Oncolytic Viruses, that selectively target tumor cells, and can be used on the treatment of different cancer types. There are several ongoing early-stage clinical trials, both in Europe and in the USA, which use materials manufactured and certified by GenIbet.

On the vaccines field GenIbet has been actively engaged with the University of Oxford/Jenner Institute on the scale up and GMP manufacturing of several of their malaria vaccine candidates, two of which are already being used in Clinical Trials. In addition, GenIbet partnered with Moderna at an early stage, having manufactured their very first mRNA vaccine candidate to reach clinical trials. As stated by Moderna´s CEO, Stephane Bancel, “Moderna is very thankful to GenIbet Biopharmaceuticals. They partnered together to take the very first Moderna mRNA vaccine in the clinic at the end of 2015. The GenIbet team provided Moderna with a high quality GMP product and we are thankful for its work.”

A LOOK TO THE FUTURE
We are committed to continue engaging with our customers to enable the earliest access to new potentially lifesaving medicines, while assuring patients safety and maintaining the highest standards on product and service quality.

GENIBET

www.genibet.com
Edifício da BPU do iBET
Av. da República
Quinta do Marquês
2780-157 Oeiras
Portugal

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