Frequently Asked Questions (FAQ)

What makes Osilaris different from conventional cell-expansion systems?

Osilaris combines capabilities that are often distributed across several instruments and manual operations. The platform supports adherent and suspension cells, progressive volume and growth-surface expansion, low-shear gravity-based mixing, cell-site pH and dissolved oxygen measurement, perfusion, in-bag washing and closed harvest.

It is also ecosystem-agnostic. Users can work with their preferred media, reagents, microcarriers and adjacent processing technologies. They can also connect through weldable tubing and adapt preset protocols through an intuitive touchscreen interface. Together with application and process-development support from Scinus experts, this gives users greater control over their process without locking them into a single reagent or equipment ecosystem.

Which cell types can be cultured in Osilaris?

Osilaris has been used successfully with a broad range of cell types, including mesenchymal stromal cells (MSCs), induced pluripotent stem cells (iPSCs), T cells and CAR-T cells, natural killer (NK) cells, tumor-infiltrating lymphocytes (TILs), HEK293 cells and liver organoids.

Other cell types may also be compatible. Suitability depends on factors such as attachment requirements, aggregate formation, media composition, oxygen demand, mixing sensitivity and harvest strategy. Scinus can support feasibility assessment and process translation for new applications.

How do the adherent and suspension culture bags differ?

The adherent culture bag is designed for microcarrier-based processes and supports progressive expansion of culture volume and available growth surface. It can be used for applications such as MSC, and HEK293 expansion. The suspension culture bag is designed for immune cells, HSCs, iPSC spheroids, Organoids and other suspension processes. 

Both bags are equipped with filters that enable in-bag washing, media exchange and perfusion while retaining either the microcarriers, or the cell  suspensions . For this purpose they differ in the pore size of their filters, 100 µm for the adherent and          1 µm for the suspension bag respectively. Both consumable formats use the same Osilaris controller and support closed processing, integrated sensing and configurable protocols.

Can Immune cell selection be integrated with Osilaris?

Yes. Akadeum's buoyancy-activated cell sorting (BACS) technology has been successfully demonstrated in the Osilaris suspension bag. In a negative-selection workflow, antibody-functionalized microbubbles lift unwanted cells away while the desired cells remain unlabeled in the product fraction.

BACS does not require magnetic separation hardware and can be followed by activation and expansion within the same platform. This can reduce equipment requirements, transfers and manual handling at the start of an immune-cell process. Other selection technologies can also be connected through the Osilaris closed tubing architecture, subject to process-specific development and validation.

What working volumes does Osilaris support?

Osilaris supports working volumes from approximately 50 mL to 1.2 L, or up to approximately 1.4 L with manual adjustment. 2 L of media or buffer, can be further added in the circulation loop. This wide operating range allows users to begin with a relatively small inoculum and expand progressively without transferring the culture to a different bioreactor. 

How does Osilaris support scale-up?

Osilaris enables scale-up by progressively increasing culture volume and, for adherent processes, available growth surface within the same closed culture bag. This reduces vessel changes, connection steps and process transfers while maintaining control of pH, dissolved oxygen, temperature, mixing and media supply.

Because development and larger-volume expansion can take place on the same platform, users can reduce the process changes normally introduced when moving from laboratory vessels to manufacturing equipment.

How does Osilaris support cell expansion without passaging?

How does Osilaris support cell expansion without passaging?

For adherent cells, Osilaris supports expansion through bead-to-bead transfer: cells migrate from occupied microcarriers onto newly added ones, avoiding enzymatic detachment and intermediate passaging. Programmable rocking and static intervals support this transfer as the culture volume and available growth surface increase.

For suspension cells, the culture volume increases as cells multiply, allowing expansion within the same bag without transfers to larger vessels. Controlled mixing, pH, dissolved oxygen and temperature support growth, while perfusion enables fresh medium supply and waste removal.

Both approaches keep expansion within a single closed system, reducing manual handling and contamination risk.

Does Osilaris support perfusion culture?

Yes. Osilaris supports perfusion workflows for both adherent and suspension cultures. Integrated cell- and microcarrier-retention filters enable controlled media addition and removal while retaining the culture in the bag.

Perfusion can replenish nutrients, remove inhibitory metabolites and support higher-density cultures. Depending on the application, the same functionality can also enable in-bag washing, media exchange or collection of cell-free product fractions without opening the system.

Does Osilaris support closed harvesting?

Yes. Osilaris supports process-specific harvesting within the closed single-use flow path. Integrated filters enable in-bag washing and media exchange, while weldable tubing allows the harvested product to be transferred aseptically to downstream concentration, formulation or fill-and-finish equipment.

For adherent and microcarrier processes, harvest reagents and operating parameters can be incorporated into a configurable protocol. The harvest strategy should be optimized and validated for the selected cell type, microcarrier and final-product requirements.

Can customers use their own media, reagents and microcarriers?

Yes. Osilaris is designed as an ecosystem-agnostic platform and is compatible with customer-selected media, cytokines, supplements, activation reagents, harvest solutions and microcarriers. This allows users to transfer established workflows, compare suppliers and optimize processes without being tied to a proprietary reagent portfolio.

Material compatibility and process performance should be confirmed for each application. Scinus can assist with protocol translation, microcarrier screening and process optimization.

Can Osilaris support both viral-vector and immune-cell workflows?

Yes. Using separate application-specific single-use consumables, the same Osilaris platform can support adherent HEK293 culture on microcarriers and suspension immune-cell processes. This creates the option to develop viral-vector production in one run and perform immune-cell transduction and expansion in a separate run on the same core platform.

Bringing these capabilities onto one configurable system can simplify equipment strategy, training and technology transfer. Each vector and cell-manufacturing process, including purification and biosafety controls, must still be developed and qualified for its intended use. 

Is Osilaris suitable for GMP manufacturing?

Osilaris is designed to support GMP-aligned manufacturing through its functionally closed architecture, pre-sterilized single-use consumables, automated process control and digital traceability. The platform provides user-access control, on-device data logging, audit trails and support for 21 CFR Part 11 and EU GMP Annex 1, 11 and 15 compliance. DQ, IQ and OQ  support is available.

GMP status ultimately applies to the complete manufacturing process and facility, not to the bioreactor alone. Final equipment qualification, process validation, ancillary-material qualification and regulatory approval remain the responsibility of the user.

Is Osilaris a closed system?

Osilaris is designed to operate as a functionally closed, single-use bioreactor system. Pre-sterilized, double-packed culture bags incorporate weldable tubing, closed fluid-transfer paths, optical sensors, pressure monitoring and cell- or microcarrier-retention filters. The bags connect to the Carboxygenator for gas exchange without opening the process.

When connected and operated using validated aseptic procedures, the system avoids routine open handling during expansion, media exchange, sampling and harvest. The final closed status depends on the complete user-configured process, including all upstream and downstream connections.

How does Osilaris reduce contamination risk?

Osilaris reduces contamination risk by combining closed processing, pre-sterilized single-use consumables, automated control and fewer operator interventions. Progressive expansion within one bag reduces vessel transfers, while weldable tubing supports aseptic connection to upstream and downstream equipment.

The single-use flow path also removes the need to clean and sterilize product-contact surfaces between runs, reducing cleaning-validation requirements and the risk of cross-run carryover.

Can Osilaris support decentralized manufacturing?

Yes. Osilaris is designed to support the transition from process development to decentralized, GMP-aligned manufacturing. Its compact footprint, closed single-use workflow, configurable recipes, 120 V and 230 V options, digital audit trail and remote or LAN connectivity can help standardize operation across distributed manufacturing sites.

Together with application-specific training and Scinus process support, these features can help organizations deploy a consistent process closer to the patient while retaining central oversight of methods and data. Site qualification, process validation and local regulatory requirements remain the user's responsibility.

What cleanroom classification is required?

The appropriate cleanroom classification depends on the complete process, facility design, applicable regulations and the user's contamination-control strategy. Because Osilaris is functionally closed and avoids routine open handling, it may support operation in Grade C or Grade D environments where justified by a documented quality risk assessment.

The final room classification and any requirement for local Grade A protection must be determined by the user's quality organization and relevant regulatory authorities.

Is process data logged?

Yes. Osilaris records process parameters and events throughout the run and provides user management, data storage and audit trails. Data can be exported for process analysis, quality review, batch documentation and technology transfer.

The complimentary Scinus Data Report Generator converts exported run data into clear, standardized reports, reducing manual data handling and making it easier to review trends, compare runs and document process performance.

What documentation is available to support GMP compliance?

Available documentation includes Instructions for Use, technical datasheets, material declarations, certificates of analysis and conformity, sterility-validation information, extractables and leachables data, and training materials. Qualification support can include DQ, IQ and OQ documentation, together with information supporting EU GMP Annex 1, 11 and 15 and 21 CFR Part 11 assessments.

Document availability may vary by system configuration and consumable. Scinus can help users define the documentation package required for procurement, qualification and regulatory submissions.

What is the Carboxygenator?

The Carboxygenator™ is the membrane-based gas-exchange module of the Osilaris system. Culture medium is circulated past a gas-permeable membrane where oxygen, nitrogen and carbon dioxide are exchanged to control dissolved oxygen and pH.

By separating the gas phase from the cell-culture chamber, the Carboxygenator enables controlled gas transfer without direct sparging of the culture. This helps limit bubble formation and supports a gentle culture environment for shear-sensitive cells.

How is oxygen controlled in Osilaris?

Osilaris continuously measures dissolved oxygen using a single-use optical sensor integrated into the culture bag. The controller adjusts the balance of oxygen and nitrogen supplied to the Carboxygenator to maintain the user-defined setpoint.

The system supports a wide dissolved-oxygen range, including controlled hypoxic conditions, allowing users to tailor oxygen availability to the biology of the selected cell type and process stage.

How is pH controlled in Osilaris?

Osilaris measures pH continuously using an optical sensor integrated into the culture bag. The system regulates carbon dioxide transfer through the Carboxygenator and uses the bicarbonate buffering capacity of the culture medium: increasing dissolved CO2 lowers pH, while reducing CO2 allows pH to rise.

Control performance depends on the buffering system and operating conditions of the selected medium, which should be confirmed during process development.

How is temperature controlled in Osilaris?

Osilaris provides automated temperature control from ambient temperature up to 45 °C. The temperature setpoint can be incorporated into the process protocol and recorded with the other critical process parameters throughout the run.

Why does Osilaris use oxygen transfer rate instead of kLa?

Oxygen transfer rate (OTR) describes the amount of oxygen transferred to the culture per unit of time under defined operating conditions. It can therefore be compared directly with the oxygen demand of a cell process.

kLa is a useful mass-transfer coefficient, but it depends strongly on reactor geometry, mixing and operating conditions and does not by itself state how much oxygen is available to the culture. OTR provides a more practical measure of oxygen-supply capacity for the membrane-based Osilaris configuration.

How are pH and dissolved oxygen measured in Osilaris?

Single-use optical sensor patches for pH and dissolved oxygen are integrated into the culture bag and remain in direct contact with the culture fluid. External optical readers measure the sensors through the bag without breaching the closed fluid path.

This design enables continuous monitoring while avoiding reusable probes that require cleaning, sterilization and insertion into the culture vessel.

How does the pressure-monitoring system work in Osilaris?

A single-use pressure sensor integrated into the fluid path continuously monitors internal bag pressure. Pressure data support safe volume expansion, perfusion, fluid-transfer operations and maintenance of the intended bag geometry.

Monitoring also enables the system to detect abnormal pressure conditions that may indicate a restricted fluid path, filter loading or an operating deviation.