how advancements in pump technology are reducing downtime ...€¦ · 19/11/2019 · report: how...

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Report: How Advancements in Pump Technology Are Reducing Downtime in Biopharmaceutical Manufacturing

By Dr. Andreas Frerix, Product Manager for Quattroflow™ Fluid Systems

Objectives of This Report:

• To provide an overview of the critical pump functions needed for today’s biopharmaceutical processing operations

• To illustrate how 3 critical advancements in pump technologies streamline biopharmaceutical manufacturing

Biopharmaceutical manufacturers are at the intersection of two pervasive challenges: the need to produce complex biological drugs that are safe for human use, and the need to get them to the market in a manner that maximizes the earning potential of patent windows. With global spending on medicines reaching $1.2 trillion in 2018¹, there is a lot at stake for biopharmaceutical manufacturers. Drug and therapy suppliers who strike the optimal balance between precision processing and speed to market will establish a competitive advantage in the market.

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BIOPHARMACEUTICAL PUMP CHALLENGES

The most common systems in biopharmaceutical manufacturing handle, transfer, process and purify large-molecule drugs. These drugs are produced in living organisms – such as animal-cell cultures, bacterial cells or yeast – and in a liquid phase.

The production process comprises two primary stages:

Traditionally, permanent stainless-steel pumping systems have been used to complete these processing stages. However, the time and cost required for operating, cleaning, maintaining and performing quality control measures for stainless steel pumps before the next production run could begin have become prohibitive. Furthermore, today’s biopharmaceutical manufacturing demands pump technologies that can handle the delicate materials used in biopharmaceutical manufacturing without damaging them. Biological drug development requires pumps that can reliably provide:


STAGE 1: Upstream Processing Growth & Harvest:

Genetically modified cells, suspended in liquid culture media, are grown in bioreactors to produce the desired product.

STAGE 2: Downstream Processing Separation & Purification:

The target molecule is separated from cells and byproducts and is purified.

• Volumetric consistency and accuracy

• Pressures and flow rates• Low pulsation

• Low-shear, low-heat input• Material compatibility

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BIOPHARMACEUTICAL PUMP SOLUTIONS

Three notable innovations in pumping technology – the quaternary diaphragm pump, single-use pumps and new pump chamber replacement systems – are helping biopharmaceutical manufacturers meet both stringent product quality requirements and improve speed to market.

Pump Innovation #1: The PD Quaternary Diaphragm Pump Positive displacement quaternary diaphragm pumps – whether used in traditional stainless-steel or single-use setups – feature a unique form of operation that keeps product flow constantly moving forward in a volumetrically consistent low-shear and low-pulse manner. Their adoption into several unit operations – including tangential flow filtration, chromatography columns and virus filtration – have helped manufacturers adhere to an unbending set of operational parameters and structures.

The pump’s four pumping chambers operate in the same way the human heart does. The four quaternary diaphragms are driven one after another by a connector plate, which moves back and forth out of its central position in a stroke that is generated

by an eccentric shaft, with the length of the stroke determined by the angle of the eccentricity.

The pump’s chambers also contain no rotating parts that can be subject to friction. Therefore, there is minimal heat buildup that can compromise the product. The pumps can run dry, are self-priming, and produce minimal shear because of low slip. In addition, they offer low-pulsation, leak-free operation while providing favorable dry/wet suction-lift capabilities.

Pump Innovation #2: Single-Use PumpsSingle-use technologies (SUT) provide many benefits to biomanufacturing, including:²

• Lower capital costs systemwide

• Flexibility for facility design and scalability of equipment

• The opportunity to develop closed systems for smaller footprints

• A similar or lower environmental impact than stainless steel

But perhaps the greatest advantage of SUT is speed. Systemwide, the installation of SUT can be much faster than stainless steel – the lack of CIP and SIP piping and controls significantly reduces design engineering and installation.² SUT also creates significant production efficiencies.

Since their introduction, single-use pumps have been a key component to reducing time between production runs in biopharmaceutical manufacturing. These pumps feature a disposable pump head and chamber that is quickly and easily removed and replaced between production cycles. This innovation has eliminated the time and cost needed to revalidate the equipment used in a traditional stainless-steel system. Single-use pumps also eliminate the risk of cross-batch or cross-product contamination.


Solving Scaleup As products go from development to clinical trials and then to commercialization, proper scaleup is essential. The same pump in a lab may need to handle flow rates as low as ½ ounce per minute while also being able to deliver commercial production flow rates of 50 gallons per minute or more. The quaternary diaphragm pump’s turndown capability and flow range are uniquely designed to facilitate scaleup in the biopharmaceutical industry.

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Pump Innovation #3: Optimization of Pump Chamber ReplacementAlthough single-use pump technology addressed how to reduce cleaning, revalidation time and costs after production runs, there was still room for improvement with pump-head replacement.

A breakthrough came in 2017 with the introduction of the EZ-Set model, a pump-chamber replacement system created by Quattroflow™, Duisburg, Germany, a product brand of PSG®, Oakbrook Terrace, IL, USA, a Dover company. The EZ-Set model allows operators to replace a single-use pump chamber in 30 seconds or less. Torque wrenches, or other special tools, are not needed to complete the change-out, and operators are able to wear rubber gloves during the pump chamber replacement.

The process is completed in 5 simple steps:

1. Remove the pump’s pressure plate

2. Pull the pump chamber from the ring drive

3. Push the new pump chamber onto the ring drive

4. Reinstall the pressure plate

5. Slightly rotate the pressure plate to lock according to the markings

The simplicity of the replacement eliminates downtime in the production-changeover process, which leads to further optimization of the product-development timeline.

BIOPHARMACEUTICAL PUMP SOLUTIONS

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CONCLUSION

Although production of biopharmaceuticals is an intricate, complex process, advancements in pump technology make it possible for manufacturers to produce biologic drugs that are safe, effective and realize the financial benefits of an optimized patent window. The introduction of single-use pumps virtually eliminated the cost and downtime that were previously required to clean and validate traditional stainless steel pumping systems. The development of the positive displacement quaternary diaphragm pump provided the industry with a pump design that enables various unit operations to meet a series of strict product-handling and -transferring requirements. Finally, the creation of the pump-chamber replacement system will help biologic developers to further optimize time, cost, reliability and safety capabilities in critical biopharmaceutical-manufacturing applications.

References:

1. “The Global Use of Medicine in 2019 and Outlook to 2023.” IQVIA. https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023, accessed Oct. 25, 2019.

2. Wong, Ken; Johnson, Jeffrey; Kline, Sally; Repetto, Robert, Mahajan, Ekta.“BPOG Five-Year Vision for Single-Use Technologies.” American Pharmaceutical Review. https://www.americanpharmaceuticalreview.com/Featured-Articles/335494-BPOG-Five-Year-Vision-for-Single-Use-Technologies/, accessed Oct. 25, 2019.


Dr. Andreas Frerix is the Product Manager for Quattroflow™ pumps. Dr. Frerix can be reached at +49 2065 89205 39 or [email protected]. Based in Duisburg, Germany, Quattroflow offers a full line of positive displacement multi-use and single-use quaternary (four-piston) diaphragm pumps and accessories for use in the biotech, food-and-beverage, personal-care and nutrition industries. Quattroflow is a product brand of PSG®, a Dover company, Oakbrook Terrace, IL, USA. PSG is comprised of several leading pump brands, including Abaque®, All-Flo, Almatec®, Blackmer®, Ebsray®, EnviroGear®, Griswold™, Mouvex®, Neptune™, Quattroflow™, RedScrew™ and Wilden®. You can find more information on Quattroflow at quattroflow.com and on PSG at psgdover.com.

ABOUT THE AUTHOR:

ABOUT PHARMOVATE-TRIANGLE PROCESS EQUIPMENT:PharmOvate-Triangle Process Equipment is a leader in meeting the process equipment needs of the pharmaceutical, food and beverage, and cosmetics industries. Learn more at www.4tpe.com.

how advancements in pump technology are reducing downtime ...€¦ · 19/11/2019 · report: how...

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