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Novasep

Purification Solutions for the Pharmaceutical and Biopharmaceutical Industries

Novasep is a global provider of cost-effective and sustainable manufacturing solutions for the life science sector, as well as of molecules for pharmaceutical, biopharmaceutical and other fine chemical applications.

From the development stage right up to industrial scaling, we provide a complementary range of GMP equipment and services for purification. Modular and customizable, our chromatography equipment can integrate seamlessly into any process.

Operating both as a drug substance producer and an equipment supplier, Novasep has deep insight into the challenges and performance drivers of pharmaceutical and biopharmaceutical manufacturing: time to market, minimizing cost of goods (CoG), quality control, recipe management, monitoring strategy, to name a few. This dual expertise enabled us to embed these requirements right from the start when designing our chromatography equipment, for optimal effectiveness in development and manufacturing processes.

Leading provider of HPLC solutions for the API purification process

Novasep offers a range of products and solutions that cater for all stages and scales of operation, from the development phase to large-scale commercial production.

The state-of-the-art and exclusive Prochrom® skids are designed for intermediate purification and polishing of APIs, biologics, peptides, oligonucleotides, insulin, cannabinoids, amongst others. Hipersep® Pilot is our new modular, compact and ergonomic system which is designed to minimize sanitary cross-contamination risk and which, with over 1,000 possible configurations, will integrate with any process. Cyclojet is an innovative chromatography process designed for optimal productivity, particularly in cases of limited batch process resolution.

Novasep is also a pioneering supplier of Dynamic Axial Compression columns for pharmaceutical applications, offering a complete range from lab to industrial-scale ID columns (from 50 to 1,600 mm – higher upon request), ensuring the best packing performance whatever your stationary phase. We also developed the Prochrom® Pack-n-Sep lab columns, even more convenient and designed for ultra-fast packing requirements.

Varicol® is a multicolumn continuous chromatography concept particularly well suited to large-scale separation of binary mixtures (e.g. enantiomers, stereoisomers) and fractionation of complex mixtures (e.g. natural extracts). This technology is designed to adapt seamlessly to specific user requirement specifications, based on each customer applications and processes.

Upon request, we can combine our chromatography equipment with automated solvent recycling technology. This enables the recovery of up to 99% of the solvent in both isocratic and gradient conditions, thus dramatically reducing your operating costs and environmental footprint.

Downstream bioprocessing and process intensification

Novasep has decades of experience in designing, developing and operating continuous manufacturing processes. Most notably, we have built the largest FDA-audited commercial-scale continuous chromatography platform. In order to adapt to the current biopharma challenges, Novasep is committed to delivering deep expertise and know-how in continuous chromatography. A testament to this commitment is the state-of-the-art BioSC™ Sequential Chromatography platform that we have created.

The Novasep BioSC™ technology caters for all requirements in the field of biologics purification, from the process development stage to industrial-scale operations. It is the first technology of its kind to enable multiple multi-column processes, as well as integrating downstream process steps.

Our new system BioSC™ equipment family can operate three chromatography separations simultaneously and continuously, including viral inactivation and buffer preparation. The ability to chain multiple processes results in a streamlined and intensified process. Its modular design makes it easy to build a complete purification process based on your exact requirements.

BioSC™ Predict is an exclusive simulation and optimization software for the development of continuous chromatography processes for biopharmaceutical purification. This process development accelerator enables any scientist to start developing their own continuous chromatography processes even without prior knowledge. With a few clicks, the user can switch from batch chromatography to an optimized continuous chromatography process, ready to be tested with BioSC™ Lab and BioSC™ Pilot.

Customer services

As well as designing and manufacturing specialized equipment, we also operate them in various Novasep-certified production plants. We are therefore our own customer and, as such, we have acquired deep and extensive experience in validating our equipment most efficiently.

We can share this expertise to:

  • Help you to reduce your equipment qualification timeframes (FAT, SAT, IQ/OQ protocol and execution)
  • Dispatch a cGMP trained team to carry out qualification tests
  • Document all qualification process steps with specific tests, protocols and reports
  • Support you throughout your equipment lifecycle
  • Identify spare parts and repairs inventory
  • Maintain equipment excellence (updates and upgrades)
  • Provide tailor-made application training to optimize your purification process
  • Offer service agreements for all your equipment
  • Train and educate your operators and teams (theory and practice)
  • Process development support

Contact details

Europe
Novasep Process
Site Eiffel
81 boulevard de la Moselle – BP 50
54340 Pompey – France
Phone: +33 3 83 49 70 00
Fax: +33 3 83 49 70 02
Email: novasep@novasep.com
Web: https://www.novasep.com/

Americas
Novasep LLC
23 Creek Circle
Boothwyn, PA 19061 – USA
Phone: +1 484 361 6000
Fax: +1 610 494 1988
Email: novasep@novasep.com
Web: https://www.novasep.com/

Asia
Novasep Asia
Building No.4,
Lane 1690, Zhangheng Road,
Zhangjiang Hi-Tech Park,
Shanghai 201203 – CHINA
Phone: +86 (0)21 6045 1600
Fax: +86 (0)21 6045 1699
Email: novasep@novasep.com
Web: https://www.novasep.com/

India
Novasep India
Four Square Elegant,
Block A, Flat 110,
Madhavapuri Hills, Road 5,
Hyderabad-500050
INDIA
Phone: +91 9866573377
Email: novasep@novasep.com
Web: https://www.novasep.com/

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