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.
Related Technologies
Expression Systems
Expression Systems
We have expertise with mammalian cells (BHK, CHO, HEK293, CAP, Caco2, MRC-5, Sp2/0, BAE, Vero, MDCK, DK, A549, ExpiCHO-S, NK-92), insect cells (Sf-9, ExpiSf9, Super-Sf9, High Five - with and without Baculovirus Expression Vector System - BEVS) and microorganisms (bacteria and yeast). We work with single-cell suspensions and anchorage-dependent cells, using microcarrier technology or aggregate systems, in bioreactors, roller bottles and cell factories.
Upstream Processing
Upstream Processing
We employ our extensive know-how and expertise in cell culture systems for bioprocess development and intensification. Our state-of-the-art culture systems comprise glass, stainless steel and single-use stirred-tank bioreactors (up to 50 L) and single-use, rocking motion bioreactors (up to 25 L). Bioreactor operation modes used include batch, fed-batch, perfusion and continuous.
Downstream Processing
Downstream Processing
We target innovative solutions for increasing product recovery yields and quality. Current purification approaches combine scalable membrane and chromatography-based technologies (e.g. using ÄKTA platform) with filtration-based strategies (ultra and microfiltration systems, dead-end filtration and tangential flow filtration using hollow fibers and flat sheet cassettes). Integrated continuous purification approaches are also available using continuous or multi-column chromatographic purification systems tailored to the product features.
Bioanalytics for product characterization and purity assessment
Bioanalytics for product characterization and purity assessment
Development of in-process assays and bioanalytical tools to assess critical quality attributes of viruses, cells and proteins, compatible with technology transfer and GMP requirements. Available technologies include: cell-based potency assays, SDS-PAGE, Western blot, ELISA, Plaque Assays, RT-PCR, capillary electrophoresis-based methods, nanoparticle tracking analysis, dynamic light scattering, mass photometry and surface plasmon resonance based-methods, FACS, HPLC, Endotoxin analyses. Other complex methodologies or validation procedures can be implemented under request in collaboration with iBET’s Analytical Services Unit, Mass Spectrometry Unit and our Molecular Biophysics Team.
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.
Highlights
Highlighted Publications
Continuous Affinity Purification of Adeno-Associated Virus Using Periodic Counter-Current Chromatography
PharmaceuticsDevelopment of versatile affinity-based system for one step purification process: Case of Group A Streptococcus vaccine
Biotechnology and BioengineeringAAV process intensification by perfusion bioreaction and integrated clarification
Frontiers in Bioengineering and Biotechnology
Production of high-quality SARS-CoV-2 antigens: Impact of bioprocess and storage on glycosylation, biophysical attributes, and ELISA serologic tests performance
Biotechnology and BioengineeringInterested in our Late-Stage R&D and Bioproduction R&D services?
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