Centrifugation plays a key role in many of the bioprocessing steps involved in the manufacture of cell and gene therapies, from harvesting and clarification through to purification, concentration and polishing steps.
Recent years have seen significant advances in centrifugation technologies designed for upstream and downstream bioprocessing workflows, with modern solutions now addressing many of the critical considerations in cell and gene therapy production.
Enhancing contamination control in cell and gene therapy production
Cell culture contamination is a major issue for cell and gene therapy manufacturers, and can seriously compromise the safety and integrity of therapeutic products. Given that contamination is not always easy to recognize, prevention is often the best strategy. Eliminating contamination in critical sterile liquid-handling applications requires using vessels and containers that have been sterilized and manipulated in clean air environments or closed systems. To make controlling contamination easier and more efficient, Thermo Fisher Scientific has developed a range of sterilized, single-use BioProcess Containers (BPCs) that are ready-to-use, require no post-use cleaning and support a wide variety of bioprocessing applications. The Thermo Scientific Harvestainer BPCs, for example, are closed-system solutions that are ideal for harvesting adherent cell cultures grown on microcarrier beads, and feature a sterile connection to the culture vessel and harvest tank. These single-use products enable cell and gene therapy manufacturers operating small or large-scale applications to minimize the risk of contamination, while streamlining workflows and leveraging efficiencies.
Supporting scalability and flexibility in bioprocessing workflows
Workflow scalability and flexibility are key considerations in cell and gene therapy production, with the most agile manufacturers able to rapidly expand batch production capacity and cell recovery without the need to invest additional capital in equipment.
Centrifugation systems in the Thermo Scientific Sorvall portfolio are designed to provide manufacturers with the scalability and flexibility they need for their bioprocessing applications, offering a choice of rotor capacity, container volume and core volume to suit the differing requirements of supernatant harvesting, clarification, purification and polishing steps. The Thermo Scientific Sorvall LYNX Superspeed centrifuges, for example, provide up to 6-liter capacity and are compatible with 19 available rotor options to support labware from microplates through to 1 liter bottles. The Sorvall centrifuges also provide extensive flexibility in parameters such as g-force, separation time, bowl temperature and acceleration-deceleration slope to meet the individual demands of specific cell and gene therapy products and workflows.
Supporting compliance in the GMP manufacturing environment
Compliance with Good Manufacturing Practice (GMP) is essential for the development and manufacture of cell and gene therapies, playing a vital part in protecting patient safety by ensuring the production of consistently safe and effective products. However, maintaining compliance requires robust qualification and documentation procedures.
The Thermo Scientific Sorvall centrifuge systems are designed and built in accordance with global standards, including ISO certified manufacturing standards and CFR21 Part 11 requirements, to meet relevant regulatory requirements. What’s more, the Sorvall centrifuges come with an extensive package of documentation, including product contact parts certification, to help reduce the burden of compliance and increase audit readiness.
Thermo Fisher also offers a broad range of field compliance services for cell and gene therapy manufacturers, including installation and operation qualification (IQ/OQ) validation. By providing a robust package of GMP-focused centrifugation technologies, documentation and service support, the Thermo Fisher solutions are helping cell and gene therapy manufacturers ease compliance and assure production of high-quality products.
Learn how modern centrifugation solutions can streamline your bioprocessing workflows
Discover how advanced centrifugation technologies are addressing key challenges in cell and gene therapy manufacturing by watching this on-demand webinar.
This product is intended for General Laboratory Use. It is the customer’s responsibility to ensure that the performance of the product is suitable for customer’s specific use or application