Vekamaf news

Single Use Bioreactors - Making them Big

February 18, 2012

Large volume production is a must for the cell therapy sector according to ATMI, which claims the latest addition to its single-use bioreactor range can help manufacturers overcome the GMP hurdles that hinder commercial scale-up.

 

ATMI  launched a new technology for enabling large-scale, cell-based manufacturing as the company unveiled its Integrity™ Xpansion™ Bioreactor Systems at the Cell Therapy Manufacturing Conference in Brussels, Belgium. The new line of bioreactors are part of the ATMI LifeSciences Integrity family of single-use technologies and have been especially developed for fragile adherent cell culture applications (such as stem cells) on a large scale. The Integrity Xpansion product line represents the first commercially-available bioreactors that support safe and cost-efficient large-scale (large volume) production of traditional two-dimensional (2-D) cell cultures with the advantage of cell culture parameter controls.
 
 
 
- Compact and efficient, 2D multiplate design
 
 
 
- Scalable, single use closed system
 
 
 
- Cell Culture parameters control
 
 
 
- Cell Morphology and density monitoring
 
 
 
 
 
 
"It is essential that cell therapies can be made efficiently and effectively on a large scale for them to reach the market. Yet, it can be a challenge to achieve GMP standards during large-scale production because of a lack of efficient cell culture technologies — many of which can lead to bottlenecks and prohibitive costs," says Jose Castillo, the global director of cell culture technologies for ATMI LifeSciences. "The Xpansion bioreactors represent a solution for process industrialization for cell therapies. Both patient safety and GMP compliance have been factored into the system's design, as has operational simplicity. Space and cost requirements have been drastically reduced, enabling the user to operate in a manner that existing large-scale technologies cannot match."

ATMI Life Sciences - Cell Therapy Process and Cost Model Simulations.pdf

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One stop shop for bulk sterile antibiotics

February 18, 2012

Telstar delivers the largest pharmaceutical containment project ever fulfilled in China by a single company. The project integrated dosing, freeze-drying, unloading and end-packing of bulk sterile antibiotics and comprised three identical systems to maximise production flexibility.

 

Telstar has managed the entire project, from technology design and trialling to installation and training. Implementing such a complex project is achieved by close collaboration between Telstar's global centres of excellence - freeze-drying in Shanghai, sterilisation in Granollers, Spain, containment at Dewsbury in the UK and loading systems in Terassa, Spain.
 
The new triple line system in China not only contains and protects vulnerable Active Pharmaceutical Ingredient (API), it also ensures the safety of operators, with emphasis in mind of making the entire process efficient, comfortable and easy to manage.
 

Telstar GMP Full Scale Production Freeze-Dryers LyoMega brochure.pdf

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Bottom-up filling systems with hygiene in mind

February 17, 2012

Chronos BTH R&D brings dust control to hygenic bagging solutions. Producers of babyfood, dairy and bakery ingredients welcome the new benchmark in open mouth bottom-up filling machines.

 

The OMLH-1030 BF SERIES and the OMLH-2060 BF SERIES are compact, fully automatic packaging systems designed for the hygienic bagging of a diverse range of products into open-mouth bags. The system, which is ideal for both powders and granules, has been specifically developed for Dairy, Bakery, Babyfood and other food related industries. But pharmaceutical
or chemical applications are not uncommon.
 
 

 

 

The new system concept has been designed in accordance with the EHEDG* (European

Hygienic Engineering & Design Group) guidelines. Chronos BTH is an EHEDG member and has established an in-house Hygiene Task Force to develop and implement machine design guidelines specifically for the Food Industry. The dust poor, patented bottom‑up filling technology guarantees high accuracies during the filling process. The machine features closed bag-top transport, quick and simple cleaning, fast change-over times and minimised dust emission.
Dairy, Bakery, Babyfood and other Food related industries
 
 

CHRONOS BTH Open-mouth bottom-up filling lines.pdf

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Flexible Containment Roadshows

December 28, 2011

Increased demands for flexibility and cost pressure make flexible containment a hot topic in pharmaceutical production. Working with flexibles does require a different mindset than traditional rigid solutions and we set out on a roadshow to engage with local industries.

We teamed up with the ILC Dover, the producer of  innovative softgoods that, besides its succesful trackrecord for NASA, has made their Doverpac range the flexible containment solutions of choice for many (Bio) pharmaceutical producers.  

 

At our first event in Slovenia, close to 40 participants from Krka, Lek, Pliva and others participated. We demonstrated the use of Bag in Bag Out Systems, and how to work with continuous liners, samplers etc. We also engaged in fruitful discussions on how retrofitting exisiting equipment with flexible containment solutions can enable you to safely process more hazardous materials.

 

We are pleased to receive many useful comments and questions that will help us prepare pragmatic solutions and improve the content of the future seminars even further.  You can find some pictures from the seminar below.

 

 

    

 

 

    

Doverpac Pharmaceutical Booklet.pdf

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Weight watching your cell culture

November 21, 2011

The weighing station from Scilog has proven an instant winn for many Biotech companies. For teams working with cell culture development and upscaling, the weighing station is a much welcomed ergonomic solution amidst any single-use processing environment. 

 

Scilog Upstream/Downstream Bag Support and Weighing Platform advantages:
 
- Accommodates Process Flexibility as the WeighStation is designed for Compatibility with Bags from any Manufacturer.
- Natural Turbulent Mixing with Vertical Bag Orientation and Proper Port Placement.
- Reduction in Floor Space Footprint and Increase in Portability comparative to a floor scale.
- Mobility and Minimized Risk of Cross Contamination in using disposable bags make the WeighStation Ideal for Transport between Suites and Applications

Scilog WeighStation-Bag Support and Weighing Platform.pdf

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Continuous drying with minimal energy loss

November 21, 2011

Extensive test results have shown that the DMR continuous flash mill dryer can often replace existing spray drying processes and produce quality end products more efficiently. 

With the DMR, the wet material is fed through a series of specially designed feeding systems (1) the grinding section(2) the drying section (3) the main body of the dryer. The impact energy imparted by the grinding rotor disperses the wet material into very fine particles.

 

A temperature controlled hot gas stream coming from the air heater (4) is drawn by the exhaust fan through the main body and fluidizes the fine particles in the grinding chamber. This condition guarantees optimal heat exchange and instant evaporation of liquid.

 

The dried particles are conveyed with the gas stream to the top section of the dryer where a separator(5) classifies the particles by size. Particles passing the classifier at the set cut point are conveyed with the exhaust air (6) to a powder air separating systems such as a cyclone, cyclone filter or cyclone scrubbers. 
 

Read the full case study to find out whether the DMR is the right continuous drying technology for you: 

Hosokawa Micron BV Drymeister a compact energy saving drying process case study.pdf

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Imtech Ventilex fluidbed cooperation pays off

October 6, 2011

Imtech Ventilex has made great progress over the past year. For us, their improved capability to work with industry partners helped us make their technology accessible to our clients. 

We are proud to announce that we were awarded three fluidbed drying projects in the first half year of our renewed cooperation alone.

 

As diverse as it may sound, the applications range from the drying of EPS granules, to specialized drying of animal feed additive and a solution for a leading producer of fruits and nuts. 

 

The success story is a great example of what can happen when a leading technology provider decides to make serious work of cooperation with industry experts. Based on the commitment of the Ventilex team and a better understanding of the advantages of their solutions, we found several production facilities that will benefit from their technology and we look forward to deliver more projects in the future. 

 

Ventilex Ventinews No. 2 September 2011 Newsletter.pdf

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Ultrasonic sealing for fresh produce

October 6, 2011

The rapid expansion of VikingMasek in the United States could not go unnoticed and we have started to endorse them as our partner for stick packaging and vertical form fill and seal machines. Their unique solution for fresh food produce shows their commitment to innovation.

 

 

VIKINGMASEK now offers a special servo-controlled stainless steel VFFS machine with ultrasonic sealing system for packing lettuce (ES-400). With this system, PP / OPP films from 30 microns can be processed offering a great solution for all our clients struggling with packaging fresh produce. 

 

 

Advantages: almost 0% rejection / no visual check of the bags necessary / to 25% lower film cost. Expected return on investment in two shift production is less than 2 years!

 

 

For this development, VikingMasek teamed up with Sonotronic which has in several successful applications in operation in lettuce production. Besides lettuce, the application is suitable for fresh products, cheese, liquids, etc that is difficult to dose but needs PP / OPP sealing to be able to continue to breath to maintain its freshness. If you have a similar challenge, we look forward to working together with you for a market leading packaging solution! 

VikingMasek Sonotronic cooperation.pdf

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Standardizing Films for Single-Use Bioprocessing Vessels

October 6, 2011

More and more biopharmaceutical organizations start to realise the importance of a reliable counterpart for their disposable processing needs. 

 

Stainless steel and glass have long dominated the biomanufacturing market as accepted materials for bioprocess mixing, bioreactor, feed, collection, formulation, and shipping vessels. Although single-use storage bags quickly found their way into process development and GMP manufacturing, the concept of singleuse mixing and bioreactor vessels was not seriously considered as an option until recently. Today, most biopharmaceutical organizations accept that single-use mixing and bioreactor platforms also offer operational, technical, and economic advantages.

ATMI Standardizing Films for Single-Use Bioprocessing Vessels white paper.pdf

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We and our partners continuously try to keep you posted of the latest technologies and innovations. We hope you'll find some of the below industry news of your interest. We'd be happy to hear from you if you would like to learn more!