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Maker - Product Challenge

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Technologies

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Changemakers

Formulation technologies are an integral process in many industries such as pharma and food. Chemical mixtures require strict handling to combine the separate ingredients into the homogenized recipe that makes your final product. Formulation technology stores, mixes and subjects the elements to a range processing parameters according to your specifications to develop the base material. The resulting formulas are then weighed, formed, packaged, or sent for further formulation.

Formulation

Cell culture has been, over a little more than 100 years, an important method of research in laboratories. But medicine developments aside, we wonder if even the most positive of idealists could have also believed that cell cultures and tissue culture would possibly change the way – and what – we eat. From the lab to the dining table, there’s cell culture equipment to make even the unimaginable possible.

Cell cultures

Success with bioprocesses is all about controlling the environmental conditions controls so you can replicate processes consistently. Good insight and easy adjustment of pH, Temperature, Dissolved Oxygen, Foam/Level and Agitation are crucial for any biopharmaceutical process.


<h2>Easy to use control for lab scale operation</h2>
The ez2-Control from Getinge Applikon is an easy to use control and measurement system for bioreactors and fermentors. The bioreactor control system offers high accuracy, a good insight and easy adjustment of pH, Temperature, dissolved Oxygen, Foam/Level and Agitation, which are crucial for any biopharmaceutical process.

The colour touch screen interface guides the user through the operation.  The adaptive control features allow the user to focus on the process while the controller keeps tight control on the important process parameters.

The new web-interface for ez2-Control with advanced user management option provides a clear overview of the bioprocess parameters. Also it allows back-ups, copies and predefined settings of configurations to be simply shared via USB.

The ez2-Control can be used to control a large variety of reaction environments: From autoclavable bioreactors, steam in place bioreactors, to Appliflex single use bioreactors, milipore Cell Ready single use bioreactors or HyClone SUB bioreactors.

Lab scale Bioreactor controller

When a screening study takes place, optimizing media process and working with microbial and cell cultures is quite common. Working with small volumes reduces media costs, which in consequence maximizes bench space and such factor would normally be considered a premium benefit.


<h2>Considerably small, real bioreactors</h2>
The MiniBio from Getinge Applikon is a range of bioreactors (250 ml, 500 ml and 1000 ml total volume) is a true scale down of the laboratory scale bioreactors in the 1 to 15-liter range. The Mini bioreactors systems have the same flexibility as the laboratory scale bioreactors, which means that the MiniBio systems can be customized to fit the demands of any process.

Mini bioreactors

Sensitive bioprocess applications requires equipment that will not interfere with the chemical and biological processes being carried out.  At the same time, production bioprocesses, in particular those that involve peristaltic pumping, require robust tubing not prone to wear or mechanical failures.  Traditional transfer tubing for these more rigorous ans sensitive bioprocesses often proves inadequate.


<h2>A robust biocompatible tube designed for longevity in production peristaltic pumping applications</h2>
JM BioConnect is known for certified top of industry quality and customer service including very short lead times.  The company offers tubing solutions specifically designed for use in peristaltic pumps in bioprocess production environments. The tubes are of the PharMed BPT brand and are completely bio-compatible and less permeable to gasses and vapors than traditional silicone tubes.  This makes the PharMed BPT tubes ideal for protecting sensitive biological processes like cell culture, fermentation, separation, synthesis, and purification.  At the same time, they have been formulated for enhanced flex and wear characteristics allowing trouble free used in peristaltic pumping applications.  The combination of these qualities increases the efficiency of the bio-production process by reducing down time from tubing failure without making any sacrifices in bio compatibility.

Biocompatible tubing for peristaltic pumps

When undertaking a screening study, process development or optimisation study, you can speed up your project by growing and controlling multiple small cultures simultaneously. If time and reproducibility are critical for your project, you may consider investing in technology that will help you increase your efficiency in time and costs.


<h2>Independently control up to 24 bioreactors with one system</h2>
The Micro-matrix from Getinge Applikon is an high throughput fermentation and cell culture device which allows easy operation of 24 bioreactors in parallel. The micro-Matrix comes on a simple microtiter plate footprint, allowing independent control and measurements of the following:
<ul>
 	<li>pH,</li>
 	<li>temperature,</li>
 	<li>dissolved oxygen control, individually controlled by up to 4 separate gas additions, and</li>
 	<li>individual liquid additions.</li>
</ul>
The bioreactors are a true scale down of small scale bioreactors, giving all the functionality of their larger counterparts in a space-saving format. The accompanying software allows for simple comparisons of experimental cultures, and advanced controls such as time- and event-based control actions. The volume per bioreactor is 10ml (recommended working volume is 5ml).

&nbsp;

24 fully controlled bioreactors in a microtiter format

<span style="font-weight: 400;">Biotech and pharmaceutical development programs often require a mixing method that achieves both particle size reduction and complete cell lysis. When piloting production systems, it’s vital that you have complete control over the pressure to accommodate all cell types, and that the results of testing are completely scalable to full production.</span>
<h2>High-pressure homogenizer offering all configurations</h2>
<span style="font-weight: 400;">The DeBEE 2000 from BEE International is a complete pilot solution for high pressure homogenization in a highly compact format. Offering user-adjustable pressure control from 5,000 to 45,000 psi, the unit is suitable for a wide range of pharmaceutical and biotechnology applications and its modular design means lower costs of maintenance and repair.</span>

<span style="font-weight: 400;">This pilot unit also offers a wide range of options to suit all process and budget requirements, including Dual Feed, Dual Jet, control of cavitation, shear and impact and secondary additive feed for particle synthesis.</span>

<span style="font-weight: 400;">PLC control and HMI touch screen provide simple monitoring, and the unit is designed to be easily cleaned (Clean in Place) and portable.</span>

High pressure pilot homogenizer

<span style="font-weight: 400;">For any industrial pharmaceutical process that relies on high pressure homogenization it’s vital that the equipment used is robust enough to cope with the demands of continuous operation. More than this, modern production demands high levels of process control and automation, as well as seamless integration with plant controls and providing results that satisfy the highest regulatory demands.</span>
<h2>Homogenizer offering the highest level of automation, compliance and capacity</h2>
<span style="font-weight: 400;">The DeBEE 4000 series from BEE International is the company’s top-of-line homogenizing solution for high performance situations. Designed from the ground up to achieve the best results as efficiently as possible, the DeBEE 4000 uses DeBEE’s proprietary homogenization technology for unequalled results, coupled with a hydraulically driven vertical intensifier pumps with a slow stroke rate to provide higher pressure and higher process intensity, all with lower maintenance costs.</span>

<span style="font-weight: 400;">Featuring a PLC with bespoke HMI software and full-colour touch screen, the DeBEE 4000 offers easy access to several features including security modes and authorisations, integrations with plant controls using network data gathering, and dynamic visual schematics for at-a-glance system status and component parameters.</span>

<span style="font-weight: 400;">The DeBEE 4000 features a fully sanitary design making it ideal for pharmaceutical and biotech production, as well as use in the chemical industries.</span>

High pressure industrial homogenizer

<span style="font-weight: 400;">It’s vital that small units for experimentation can scale up with 100% accuracy. Ease of use, reliability and simple maintenance means increased work efficiency, and rapid cleaning and suitability for sanitary uses increase flexibility and improve return on investment.</span>
<h2>Cost-effective benchtop homogenizer with reliable and consistent process for R&amp;D</h2>
<span style="font-weight: 400;">The Nano DeBEE from BEE International is a market-leader in laboratory-scale homogenizers. Designed for maximum flexibility, the Nano DeBEE can be used for a range of procedures including cell disruption, particle size reduction, nano/micro emulsions and nano/micro dispersions. Despite the minimum sample size of only 5ml, the results obtained from the DeBEE are guaranteed 100% scalable to production processes.</span>

<span style="font-weight: 400;">Offering excellent value for money, the Nano DeBEE can operate at up to 45,000 PSI of pressure and yet it is simple to clean and maintain and it’s suitable for sanitary applications where required. A further major benefit is that DeBEE will provide new staff training for the lifetime of the product.</span>

High pressure electric laboratory homogenizer

<span style="font-weight: 400;">Offering lab-scale to small pharmaceutical production scale output for in one unit means maximum cost-benefit when acquiring a homogenizer. Capable of achieving a range of processes including cell disruption, particle size reduction, creating stable nano/micro emulsions and working with polymers and liposomes, this benchtop scale unit can operate at up to 15 litres per hour capacity, yet still offer lab quality results.</span>
<h2>Air-operated, compact, bench-top homogenizer suitable for a broad range of applications</h2>
<span style="font-weight: 400;">The Micro DeBEE from BEE International is a compact, laboratory-scale homogenizer that can also be used for small-scale production. This is an air-powered unit that can process as little as a single 5ml sample, up to as much as 15L per hour, offering exceptional flexibility.</span>

<span style="font-weight: 400;">Features that make it an excellent R&amp;D machine include maximum pressure of 45,000 PSI/3100 bar (at 150 PSI, 55 CFM). In addition, the back pressure can reach 5,000 PSI/350 bar, but this is adjustable to your specific process.</span>

Micro DeBEE is simple in operating, and exceptionally easy to maintain and clean (with no disassembly required), adding further to the value proposition.

High pressure air powered laboratory homogenizer

<span style="font-weight: 400;">For maximum value, a high-pressure homogenizer that’s suitable for both laboratory and pilot/small scale pharmaceutical production is the ideal choice. Full control over all process elements and 100% scalability coupled with cost-effective electric operation offers substantial cost-savings over alternative options.</span>
<h2>Cost-effective unit suited for both laboratory and pilot use</h2>
<span style="font-weight: 400;">The Mini DeBEE from BEE International is hydraulically driven homogenizer that is suitable for both laboratory use and in pilot plants or in small-scale production. Offering the highest process intensity available in its class, it will disrupt the toughest cells with the highest yield, or obtain the smallest particle size.  </span>

<span style="font-weight: 400;">With proprietary modular homogenising cell, the Mini DeBEE offers completely independent control of pressure, flow, cavitation, impact, shear and process duration. The minimal sample size of only 10ml makes it an excellent choice for R&amp;D and lab work. Because it guarantees 100% scalability, it can easily be transferred to pilot operations, or the machine itself can also be used for small-scale and batch production, offering continuous flow of up to 15 litres per hour.</span>

<span style="font-weight: 400;">PLC control with digital interface means simple operation and monitoring, with user-adjustable operating pressure from 2,000 to 45,000 PSI. Coupled with a wide range of options, this makes the Mini DeBEE suitable for application in the pharmaceutical, biotech, chemicals, cosmetics and food industries.</span>

Pilot high pressure homogenizer

<span style="font-weight: 400;">An accurate and sterile sampling of cultures is vital throughout the biopharmaceutical development process. For constant, accurate monitoring, a reliable automated system is needed that transfers bioprocess samples directly from bioreactors to a range of analytical devices without intervention while maintaining the highest levels of sterility. For small-scale development, the availability of a more cost-effective entry-level system brings large economic advantages.</span>
<h2>Affordable automated bioreactor sampling</h2>
<span style="font-weight: 400;">The Seg-Flow 1200 Automated Bioreactor Sampling System from Flownamics is an economical alternative to the larger Seg-Flow 4800. It is available in two models, the Seg-Flow 1200 and the Seg-Flow 1200 Plus.</span>

<span style="font-weight: 400;">Segmented flow technology allows rapid and accurate low volume samples to be taken from reactor vessels containing aerobic or anaerobic bacterial cultures and yeast, fungi, algae, insect, animal, and mammalian cell cultures. Samples can be either cell-containing or cell-free.</span>

<span style="font-weight: 400;">By incorporating a disposable, single-use flow path, the Seg-Flow 1200 is easy to use and requires little maintenance and no specialist operator training.</span>

<span style="font-weight: 400;">Samples can be collected from up to 2 reactors and delivered to 2 analyzers or collectors. Built-in expansion capability means this can be extended to 4 reactors with the Sample Module.</span>

<span style="font-weight: 400;">Integrated control functions such as an automated feed from an at-line glucose measurement can be quickly and easily implemented.</span>

<span style="font-weight: 400;">The Seg-Flow 1200 can be used with small laboratory vessels right up to large full-scale production vessels with 12, 19, and 25 mm models.</span>

<span style="font-weight: 400;">The unique Flownamics FISP filter probe used in the Seg-Flow 1200 ensures a sterile, cell-free sample can be taken from any vessel.</span>

&nbsp;

Entry-level automated online sampling system

<span style="font-weight: 400;">In biopharmaceutical and chemical industries, sampling is vital to develop, maintain, and improve processes. This needs to be done in aseptic conditions. The risk of contaminating either the test sample or the reactor can be eliminated by using a dedicated sampling probe designed to operate with the range of sample ports in use across all scales of production.</span>
<h2>Risk-free sampling for use with bioreactor top ports</h2>
<span style="font-weight: 400;">The Flownamics FISP F-Series is a dedicated sampling probe capable of withdrawing sterile, cell-free samples from fermenters and bioreactors with 12mm or 19mm top ports from lab scale up to production.</span>

<span style="font-weight: 400;">FISP is a sterilizable 316 stainless steel carrier that is surrounded by a tubular, microporous membrane.</span>

<span style="font-weight: 400;">FISP has been designed to withstand the temperatures, pressures, and chemicals found in fermentation environments and is perfect for aerobic or anaerobic bacteria, yeast, fungi, algae, insect, and mammalian cell cultures. Its design provides risk-free sampling thanks to a sterile barrier provided by its 0.2-micron filter. It offers the flexibility of being able to be used for submerged feeding or adding sterile media.</span>

<span style="font-weight: 400;">Compatible with Clean in Place (CIP), Sterilize in Place (SIP), and autoclaving, the FISP is easy to maintain and intuitive to use, with no specialist training required.</span>

<span style="font-weight: 400;">The FISP has been developed to work seamlessly with the Flownamics Seg-Flow range of automated samplers for use in fully automated test scenarios.</span>

Sampling probe for bioreactor samples

Comprehensive upstream data acquisition and management are essential in the bioprocessing industry. That’s because you can’t be completely sure which historic information you may need in future. SCADA monitoring systems were not designed for laboratory precision. Research work needs more focussed information.


<h2>An Information System for All Stages of Bioreactor Operation</h2>
Lucullus PIMS bioreactor software from Getinge Applikon records the entire process from recipe planning through to automatic reporting and modelling. Phases covered between these points include reactor allocation, experiment design, media preparation, media component traceability, data analysis, and data mining.

This all-embracive approach is time-saving because all information is in a central Oracle database. There’s no need to export and import data between systems. Updating is a thing of the past because you always have the latest version at hand. Moreover, the same software produces accurate spreadsheets and graphs.

Advanced software is necessary to convert data from parallel bioreactor systems into useful information. Data management is key to research and process development in the pharmaceutical industry.

Bioreactor software

Managing a large number of bioprocesses individually without automation is time-consuming, and there are possibilities of errors. Bioprocess control software moves this activity to the desktop and creates an activity log.


<h2>Bioprocess Control Software for R&amp;D Scale Bioreactors</h2>
Getinge Applikon’s V-Control bioprocess-control software is a scaled version of Emerson’s proven distributed control system. It simplifies process control, and data upscaling on a single platform. Moreover, organizations already using the DeltaV DCS at production scale have reliable, scaled information that’s easily transferred.

V-Control provides a turnkey solution that customizes to different situations. It has a user-friendly interface, and uses simple technology to minimize upscaling risks. Its easy-going technology and data transfer capabilities may reduce development costs and time-to-market.

This system is therefore ideal for a user wishing to compress start-up time, and work within an optimized DeltaV environment perfected for laboratory bioreactor systems. It is sufficiently flexible to accommodate a wide range of requirements. All hardware and software are pre-configured and ready to switch on.

Bioprocess control software

Radial flow chromatography processes require special attention and the right use of high-quality appliances in order to deliver upon specific laboratory requirements. This is where the bubble trap becomes an integral part of the process as it efficiently removes any unwanted gas or air bubbles in process fluids without providing areas where harmful bacteria could accumulate.
<h2>Bubble and gases bubble trap extractor</h2>
Bubble traps are an essential part of the pharmaceutical, food, and chemical industries that are responsible for the extraction of bubbles and gases from chromatographic processes and operations. Bubble traps are most often used in combination with Proxcys Radial Flow Chromatography columns or are simply installed inline onto piping, skids, or for stand-alone use via an expended foot.

The bubble traps are designed in accordance with customer requirement specifications and can range between volumes of 0.5L to 60L. Moreover, the bubble traps have various outlets and inlets that allow for the implementation of add-ons like an expanded feed for stand-alone use in laboratory environments. In general, the standard material of manufacturing is 316L stainless steel with a borosilicate glass cylinder. Additionally, onto the glass cylinder, a straight or at 90-degree elbow Tri-Clamp inlet and outlet to connect to piping are available for a wide range of process flows.

Still, it is completely optional to upgrade materials to a higher grade of steel. All of the materials that have been used come with the proper certifications for usage in pharmaceutical production.

Automated bubble traps for chromatography

Some of the vaccines in use today were originally developed decades ago. But advances in research, expertise and vaccine development equipment provide immunizations from bacterial and viral diseases (antibodies and cell therapy) to more people every year. The Covid 19 pandemic highlights the urgent need to scale up the production of vaccines and ensure an automated as well as reproducible manufacturing environment.

Vaccines

Getinge Applikon is the only company that can take you from the initial screening stage to full-scale production using the same platform. This minimizes scale-up risks and guarantees the shortest time to market for your new product development.

How can single use in biotech be sustainable, if you think of all the waste it creates? This might raise questions regarding the environmental impact. Let’s compare the complete life cycle of single-use systems such as tubing, capsule filters, chromatography devices, and bioreactors to their multi-use counterparts in glass or stainless steel and look at the outcome.

<h2>The end-of-life impact of single use tech</h2>
A product life cycle assessment compared single-use technologies to traditional multi use systems on points like resource extraction, processing, manufacturing, all through the end of the product life. Additionally environmental impact factors such as carbon, energy and water footprint were evaluated to paint a complete sustainable picture. Although disposal and waste remains a concern, the study found that this was actually only 1% of the total impact on the environment. Once put into use single use equipment presented a significantly lower impact resulting in <a href="https://cdn.cytivalifesciences.com/dmm3bwsv3/AssetStream.aspx?mediaformatid=10061&amp;destinationid=10016&amp;assetid=16801">a smaller overall end-of-life impact</a>.
<h2>Single use eliminates the need for cleaning in between batches</h2>
The most pressing finding is that the impact of chemicals, high purity waters and heat for cleaning and sterilization in between production batches is very high. Take for example a <a href="https://making.com/equipment/single-use-bioreactor">single use bioreactor</a> as shown in the video below; No need for extensive cleaning before the culture is started or after it’s finished and reducing the risk of cross contamination. Innovative technology such as 3D printing allows to create customizable products, while (re)creating exact replicas and keep desired process environments steady. Now officially stated as the more sustainable choice makes us understand why single systems are on the rise.

[embed]https://www.youtube.com/watch?v=RfPgrgw_wT8[/embed]

Is single use biotech equipment the more sustainable option?

Pharmaceutical

Biopharmaceuticals are drugs in which the active substance is manufactured or extracted from biological origin materials. They are usually produced in bioreactors by plant cells, microbial cells, yeast cultures, or mammalian cells. Also known as biomanufacturing, they are used to either treat or diagnose and prevent a patient’s medical condition or disease. Biopharmaceuticals are typically complex macromolecules administered by injection or infusions, and examples include vaccines, serums, and insulin.

Biopharmaceuticals

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Cell Culture Formulation

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