Cell Therapy Products and Systems for Bioprocessing

Scaling a cell therapy manufacturing process introduces technical, operational, and regulatory challenges. The variability of patient- or donor-derived starting material makes it difficult to maintain product quality and cell phenotype. Manual and open steps add complexity and increase the chance of variation between runs. As production expands, these factors drive manufacturing costs and strain facility capacity.

Meeting regulatory expectations and managing material logistics adds further pressure. Every stage from raw material sourcing to cold-chain distribution requires precise control and documentation. Without early standardization, these hurdles can increase the cost of goods (COGs) and limit how quickly therapies reach patients.

Closed and automated systems strengthen control across many stages of cell processing, from isolation and modification to expansion. By helping to minimize manual transfers, they can lower contamination risk and improve operator safety. Automation supports consistent timing, temperature, and mixing, which help enhance processes and reproducibility across runs.
 

These systems can also make scale-up more efficient by reducing the number of hands-on steps and offering reliable, traceable data for cGMP documentation. These are designed to lower manufacturing cost, facilitate faster turnaround, and promote higher product quality, which are key factors in making advanced therapies more accessible to patients.

Reliable cell therapy manufacturing depends on systems that maintain process control and verify product quality from start to finish. Tools for closed-system processing and analytical testing work together to enhance quality assurance and support cGMP compliance across the workflow:

• Gibco CTS Rotea Counterflow Centrifugation System: Automated washing, concentration, and separation steps in a closed format to help maintain cell viability and reduce contamination risk
• Gibco CTS Xenon Electroporation System: Efficient, scalable delivery of DNA, RNA, or proteins into hard-to-transfect cells
• Gibco CTS DynaCellect Magnetic Separation System: Automated, closed-system isolation of immune cells to support consistent manufacturing
• Gibco cGMP-manufactured media, reagents, and supplements: Maintain lot-to-lot consistency and support reliable cell growth and expansion
• Applied Biosystems MycoSEQ Mycoplasma Detection System: Designed to detect mycoplasma contamination rapidly and sensitively using a qPCR-based method to confirm cell culture purity in manufacturing workflows
• Applied Biosystems Rapid MicroSEQ ID Microbial Identification System: Identifies bacterial and fungal contaminants using ribosomal DNA sequencing to confirm culture purity
• Gibco CTS Cellmation Software: Connects processing instruments within a unified digital environment to record batch data, monitor process parameters, and support cGMP documentation and traceability

Transitioning from pre-clinical research to first-in-human manufacturing demands greater emphasis on quality assurance and regulatory compliance. Each step from material sourcing to final formulation must demonstrate control, traceability, and patient safety.

Some areas to prioritize include:

• Process verification: Confirm that parameters established in development perform consistently under cGMP conditions
• Material qualification: Use documented, traceable raw materials to support regulatory submissions and batch release
• Data integrity: Implement digital systems that maintain secure records and meet 21 CFR Part 11 and Annex 11 requirements
• Closed and automated workflows: Reduce contamination risk and operator variability while supporting reproducible results
• Quality documentation: Establish standardized batch records, deviation management, and change-control systems before clinical manufacturing begins

Quality systems and early regulatory alignment help safeguard patients and build confidence as therapies progress toward the clinic.

Selecting the right cell therapy system starts with understanding both immediate and future goals as the project progresses. When evaluating options, consider how each platform can support consistency, scalability, and compliance.

Some key factors to assess:

• Determine if the system integrates with your existing tools, instruments, and digital platforms to maintain data continuity
• Look for solutions that simplify data capture, review, and reporting to support cGMP documentation and process transparency
• Choose systems that can adapt from process development to clinical and commercial production without major redesign
• Modular or single-use components can shorten setup time and simplify integration as production demands change
• Prioritize tools that reduce manual steps and enable your team to maintain consistent product quality at scale