Late-Stage R&D and Bioproduction Unit

Strong base of competences in late-stage R&D, scale-up and technology transfer for complex biopharmaceuticals production.

Late-Stage R&D and Bioproduction Unit at iBET

iBET’s Late-Stage R&D and Bioproduction Unit offers a wide range of R&D services from small-scale feasibility studies to large-scale production and purification, as well as technology transfer to GMP.

Our team of highly trained experts has over 30 years of experience in developing integrated bioprocesses and analytical methods for the production, purification and characterization of complex biopharmaceuticals (e.g. recombinant proteins, viral vectors).

Fully renovated in 2019, iBET’s Late-Stage R&D and Bioproduction Unit infrastructure is in a BSL2 facility with a total area of 2000 m2, allowing scale-up to 50L.

 

Bioprocess Development and Bioanalytics

We design and develop robust upstream and downstream processes and implement bioanalytical tools suited to your existing platform and product release specifications.

 

 

Bioprocess Optimization and Intensification

We identify process limitations and provide improved protocols to maximize overall production yields while ensuring maximal product quality.

Continuous integrated bioprocess

We develop protocols combining high cell density cultures with intensified and/or integrated downstream processing technologies to increase manufacturing productivity and product quality.

Bioprocess control and supervision

We implement bioprocess control and supervision systems (incl. Process Analytical Technologies, PAT) to enhance monitoring, control and characterization of processes and products.

Bioprocess Scale-up and Tech Transfer

Bioprocess Scale-up

We establish scalable and GMP-compliant processes for production of ATMPs (e.g. AAVs, oncolytic viruses) and recombinant proteins (e.g. VLPs).
Our infrastructure allows process scale-up up to 25 L in single-use, rocking motion bioreactors and up to 50 L in single-use or stainless-steel stirred-tank bioreactors.

Technology Transfer

We perform technology transfer to CMOs or CDMOs in all steps of process development, including writing of standard operation procedures (SOPs) and shadowing of key process operations at the CMO's or CDMO’s facility.

BPU Track Record

Related Technologies

Expression Systems
Upstream Processing
Downstream Processing
Bioanalytics for product characterization and purity assessment

Related Teams

Late-Stage R&D and Bioproduction Unit Team
António Roldão

Head of the Cell-based Vaccines Development Laboratory & Coordinator of Late-Stage R&D Unit

Late-stage R&D, scale-up and technology transfer for complex biopharmaceuticals production.

Analytical Services Team
Patrícia Gomes-Alves

Head of the Sanofi Satellite Lab | Coordinator of Analytical Services Unit and Mass Spectrometry Unit

Advancing bioanalytics development to support iBET’s R&D activities and perform GMP-certified analytical services for Pharmaceutical and Biotech companies.

Mass Spectrometry Unit Team
Patrícia Gomes-Alves

Head of the Sanofi Satellite Lab | Coordinator of Analytical Services Unit and Mass Spectrometry Unit

Mass Spectrometry-based R&D services to support our partners in bioprocess understanding & development and in-depth characterization of biologics.

Downstream Process Development Lab
Cristina Peixoto

Head of Downstream Process Development lab, Coordinator of Bioproduction Unit

Ground-breaking technologies for purification of new modalities

Molecular Biophysics Lab
Tiago Bandeiras

Head of Merck Healthcare Satellite Lab & Molecular Biophysics Lab

We use a combination of Structural Biology and Biophysics methods to study human proteins involved in cancer, multiple sclerosis, cardiovascular and neurological diseases.

Highlights

Bioprocess Development for Affinity Ligands and Therapeutics
In the context of the EU-funded project DiViNe, the Late-Stage R&D and Bioproduction Team developed a bioprocess for gram-scale production of high-quality ligands/therapeutics.

In the context of the EU-funded project DiViNe, the Late-Stage R&D and Bioproduction Team developed a bioprocess for gram-scale production of high-quality ligands/therapeutics.

Our work included the optimized production and purification of nanofitin-based ligands up to 30 L, focused on optimized feeding strategy, high-cell density culture and high-volumetric productivity. This approach yielded the gram-scale production of our ligand with high quality and purity. This work was developed in partnership with Affilogic (Chevrel et al., 2022).

DiVine Project
AAV bioprocess intensification
Within the R&D projects in collaboration with Repligen (USA) and Cytiva (Sweden), iBET has implemented (i) a continuous integrated production, harvest, and clarification platform of AAVs using mammalian (HEK293) cells and transient transfection, and (ii) a continuous chromatography capture process for AAV.

Within the R&D projects in collaboration with Repligen (USA) and Cytiva (Sweden), iBET has implemented (i) a continuous integrated production, harvest, and clarification platform of AAVs using mammalian (HEK293) cells and transient transfection, and (ii) a continuous chromatography capture process for AAV. The two applications developed hold the potential to further intensify (e.g. via high cell density cultures and continuous processing) the biomanufacturing of this relevant product for gene therapy applications (Mendes et al. Frontiers in Biotechnol Bioeng, 2022, Mendes et al. Pharmaceuticals, 2022).

 

 

 

Process development and technology transfer for a new Oncolytic virus
iBET has developed and implemented a fully GMP-compatible bioprocess for oncolytic viruses.

This project included complete upstream and downstream process development with an increase in cell specific and volumetric productivity during scale-up. The protocol developed was fully scalable and successfully transferred to GMP production.

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Highlighted Publications

Advanced Technologies for Gene Therapy Products
2022
Vaccines Bioprocess Engineering
2022
Advanced Technologies for Gene Therapy Products
2022
Vaccines Bioprocess Engineering
2021
Vaccines Bioprocess Engineering
2019