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Gregg Johnson – Senior Global Product Manager
Phil Nyren – Global Product Manager Fluidics
Mike Knapp – Global Product Manager Fluidics
Time: 35-mins presentation, 25-mins Q&A: 60-mins total show time
The biopharmaceutical industry has been able to provide advanced therapies for rare diseases that were once considered untreatable by leveraging genetic engineering technology and employing the intrinsic biochemical mechanisms of bacterial and mammalian cells. However, throughout the production process, these valuable cells are lost through apoptosis, autophagy and mechanical shear, ultimately reducing the final yield.
The biopharmaceutical industry has seen extraordinary expansion over the last few years and with societal changes - such as an aging population and the advent of sophisticated diagnostic techniques - the need for biopharmaceuticals continues to grow. To meet these rising demands, a greater volume of therapeutics needs to be produced on a global scale. Improving cell survival throughout the workflow can be an effective way of increasing productivity and yield.
If you are involved in the production of biopharmaceutical drugs and therapeutics, you likely recognise the immense impact cell viability has on your final output and how increasing cell survival rates can both improve efficiency and reduce your total costs.
Masterflex® and Cole-Parmer® have developed a range of tools and solutions to support your entire biopharma workflow, resulting in better cell health and cell survival throughout the production process.
Gregg Johnson – Senior Global Product Manager
Gregg has more than 40 years’ experience in the fluid handling pump market. He has extensive background in centrifugal and positive displacement pump applications and development. His 30 years’ experience includes applications, marketing, and product development of the Masterflex® and Ismatec® peristaltic pump technology. His product development activities include launching of the first Masterflex digital drives and the initial Easy-Load® pump heads.
Philip Nyren – Global Product Manager – Masterflex® & Fluid Handling
Phil has 23 years of experience with Cole-Parmer and is currently managing the Masterflex® and Ismatec® peristaltic pump systems and equipment. Responsibilities and experience range from product concepts and development – working closely with design and engineering teams to technical support and troubleshooting working directly with customers.
Mike Knapp – Global Product Manager – Fluidics
Mike is responsible for the commercial development of single-use instrumentation and equipment. Most recently, Mike was instrumental in expanding the Masterflex® product line with the Masterflex Single-Use Gamma-Irradiated Sampling Bottle Assemblies. His prior experience includes 15 years in product management of broadband wireless technology and 7 years in nuclear propulsion operations and power generation.
For the upstream cell culture process, low shear pumps are recommended. Are there any types of peristaltic pumps that cause less shear than centrifugal or diaphragm pumps?
Peristaltic pumps are inherently low shear. The most significant factor in cell lysis reduction and reducing damage to large molecules is to lower the speed (rpm) of the pump. By oversizing the tubing — using a larger ID tube than the application might require — you are able to lower the pump speed while still maintaining a reasonable flow rate.
Also, the Masterflex® Cytoflow® pump heads (available for both the L/S® and I/P® pump series) are designed with unique convex rollers and a large rotor diameter. These both work together to lower the speed of operation and allow an area of “slippage” where cells can be “pushed” out of the roller path before the tube is fully occluded. You can get more information here: Shear-Sensitive Pumping with Peristaltic Pumps
Would you recommend peristaltic pumps for a long-term perfusion culture with high crossflow rates that goes over 60 days?
Yes. Use a TPE (thermoplastic elastomer) tubing formulation such as Masterflex PharMed® BPT or Masterflex PharmaPure®. We would also recommend using a larger tubing size, so you can run the pump at a lower speed (rpm). Tubing life is inversely proportional to pump speed.
Can you comment on gas permeability as it relates to tubing material of construction?
We publish gas permeability data on our website under the specifications for each of our pump tubing formulations. Generally, TPE- and PVC-based formulations tend to be less permeable, while silicones tend to exhibit higher gas permeabilities.
Can I use the Masterflex Ultrasonic Sensor and Controller to improve dosing accuracy?
Yes, the Masterflex Ultrasonic Sensors & Controller may improve your dosing accuracy by introducing a sensing element to the actual flow of the media, instead of the calculated flow output of the pump. Ultrasonic technology is quite accurate so this will improve most systems – especially those without any sensing element at all. However, if you are already using this technology to control your dosing system there may not be any further benefit.
We use C-Flex® and silicon tubing today in different areas of production. Is there a tubing available that is suitable for both pumping/welding/sealing in tubing size 10x16 mm?
We recommend our Masterflex Puri-Flex™ formulation. It has proven to be an excellent replacement for C-Flex in applications where sealability and weldability are required. In addition, Puri-Flex offers superior pumping life along with less spallation.
I already have several Masterflex drives. Can MasterflexLive® capability be added to my existing pumps?
Unfortunately, MasterflexLive cannot be added to existing pumps. The MasterflexLIVE communication and connection capability is built into the hardware of the pump and is not something that can be retrofit. We have numerous options for MasterflexLIVE capable pumps across the Masterflex Ismatec®, L/S®, and I/P® pump families, so there is very likely one will meet the needs of your specific application.
Is a subscription needed for MasterflexLive, and how much does it cost?
The MasterflexLive functionality is offered at two levels: Basic (free) and Premium (subscription). Basic level includes the ability to monitor pump operation and to access all pump control features remotely via a PC or mobile device. Basic level service also includes optional notifications of pump status and performance via e-mail, text, or push.
The premium (subscription) enables access to the operational data history of pumps. That operational data history includes a time-stamped record of specifically which user performed which operation. Operational data can be accessed, filtered, and downloaded. You can find more at MasterflexLive Remote Pump Control and Monitoring
Does MasterflexLive adhere to regulatory requirements/compliance, e.g. 21 CFR Part 11?
The premium subscription level that provides access to the operational history of the pump is what helps you to meet 21 CFR Part 11 and EU Annex 11 compliance.
How can I tell if my tubing has split, and/or if I have a leak in my fluid path remotely?
For remote notification, we recommend using a MasterflexLive capable pump and an accessory leak detector. The Masterflex leak detector can be placed directly underneath the pump head, or underneath a filter or any other fluid path connection that might represent a potential risk. When the leak detector sensor detects a fluid leak, it will immediately trigger the pump to stop. This is also one of the conditions that can trigger a notification via the MasterflexLive app. As noted above, you can choose to receive those notifications via e-mail, text, or push. You can find more information here: Masterflex® Leak Detector Sensors
Are there any inherent issues with running single head vs dual heads?
No. In fact, distinct benefits of dual heads include:
Question for pumping volumes from different heights: How accurate is the pump power to push liquid up above a reactor? Say the pump is on the ground. It would need to travel about 10 feet to reach the port.
This is a basic hydraulics question. We are assuming that the lift is on the discharge side of the pump. Roughly for every 2.3 feet of vertical rise (lift) you increase the pressure by 1 psi (with a fluid specific gravity of 1). A peristaltic pump with 3 bar (45 psi-g) pressure capability could lift (push) a vertical column of water over 100 ft.
How can I learn more about services offered by Masterflex in the area of process design and component specification/selection?
The first place to go is Masterflex.com. Second, you can contact our Technical support team at firstname.lastname@example.org
Is there software for the flow/pressure sensors that produce a log of your process documenting changes in flow and pressure?
The flow and pressure sensors are not data logging instruments on their own. They can through their connection with data logging equipment provide data over time. The PendoTech® pressure sensors have data logging software available that is used in conjunction with the sensors and PMAT monitors to provide data to a computer. The Masterflex Ultrasonic Controller had the ability to save CSV formatted flow data to a 32G data card that allows transfer of data to a computer.
How do I know which size flowmeter fits best for me if two meet my flow range?
There are more parameters to consider with flow rate such as pressure and scalability. We recommend working with industry experts / your supplier to find the best solution.
Do clamp ultrasonics (sensors) need regulatory approvals?
No. It does not contact the fluid path, so regulatory approvals are not required.
What does the flow controller do that the pump cannot achieve on its own?
Manual pump control is achieved be setting an rpm that have been calibrated to a desired flow rate. Over time, tubing and flow path conditions change and therefore pump rpm must be adjusted to maintain a constant flow rate. Normally, this is done by periodically running a calibration with the pump and system to determine the new pump rpm to set to achieve the same flow rate. With the ultrasonic sensor controller, the desired flow rate needs to be entered via the controller touch screen just once. The controller will speed up or slow down the pump rpm as needed to maintain the desired flow rate as system conditions change.
What are the considerations for invasive vs non-invasive solutions?
Non-invasive solutions typically have higher start-up but lower operating costs than invasive, one-time-use solutions. Often the disposable options are less sophisticated and easier to apply to a new application. Each application needs to be evaluated by the long-term anticipated usage.