Quality controls and process standardization

Integrated quality control serving research and development in organoid and extracellular vesicle

At OBBI, quality is embedded throughout the entire bioproduction pipeline—from the earliest stages of cell growth to the final release of organoids or extracellular vesicles (EVs). Our dedicated Quality control Bioprod facility provides expert support to monitor and validate key parameters across all phases of bioproduction. This ensures that every batch meets high standards of performance, reproducibility, and scalability, aligned with both scientific expectations and regulatory requirements.

Upstream Quality Controls

We implement rigorous quality checks during cell expansion, culture conditions, and bioprocess setup to ensure robust and stable growth environments for organoid and EV production. Real-time monitoring and batch-to-batch consistency are central to this phase, with continuous validation of raw materials, media, and culture conditions.

Downstream Characterization

Once the final products are obtained, we apply specific analytical methods to characterize their identity, purity, functionality, and stability. For organoids, this may include structural integrity and cellular composition; for EVs, surface markers, size distribution, and content profiling. These downstream analyses confirm that each product matches its intended use—whether for research, preclinical development, or translational applications.

Three Levels of
Quality Control

OBBI applies quality control at three distinct levels, tailored to the complexity of each product and its intended use:

Basic & Generic Controls

Standard tests for routine quality validation—such as morphology, viability, and contamination screening.

Customized assays adapted to the specific biological and functional characteristics of each organoid or extracellular vesicle type.

Basic and advanced Quality Controls for cells and 3D objects

OBBI implements a rigorous Quality Control Strategy framework to ensure the robustness, reproducibility, and compliance of organoid bioproductions.

Standard Quality Controls

  • Cell viability, morphology, and proliferation assessments to ensure high-quality production.
  • Senescence
  • Monitoring of key production parameters (e.g., oxygen levels, pH, metabolite concentrations).
  • Cell identity (cytometry)
  • Clonogenocity (CFU-f)
  • Multipotency
  • Digital RT-QPCR
  • Paracrine activity (Cytokines, SASP, Exométabolome)
  • Migratory capability
  • Angiogenic support
  • Cell fitness
  • Mitochondria Respiration
  • Size and morphology of 3D objects
  • Biomechanical properties evaluation for hydrogels and cells
  • Méthodes de culture, d’expansion, d’entretien, de congélation, décongélation

 

Advanced characterization

  • Phenotypic, transcriptomic, and proteomic profiling for in-depth biological analysis.
  • Single cell analysis including in-house innovative ML based framework for analysis of heterogeneity, cell trajectories and maturation
  • Key biomarker quantification and validation of specific functionalities.
  • High-resolution and high-throughput imaging, including 3D imaging and virtual reality for precise structural analysis.
  • Biomechanical properties evaluation for 3D objects.

 

Optimizing bioproduction with AI :

  • Building an organoid Digital shadow and digital twins: A Smart Process Control System: A digital twin is a virtual model of the bioproduction process that continuously integrates real-time data from Process Analytical Technology (PAT) tools. This allows to simulate and predict process outcomes with high accuracy, identify optimal conditions within a predefined Design Space (DS), detect variations early and adjust parameters proactively, ensure compliance with Critical Quality Attributes (CQAs) for consistent, high-quality production

 

Regulatory compliance

  • Alignment with industry standards to facilitate seamless transition into clinical and industrial applications.

 

Basic and advanced Quality Controls for extracellular vesicles

Advanced analytical solutions developed for novel applications, such as clinical like-grade standards.
This structured system ensures every project benefits from appropriate, scalable, and regulatory-aligned quality oversight—from early-stage research to pre industrial production.

OBBI Integrator
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