After transferring the media slurry into the open column, the piston is quickly mounted in a way that avoids air entry, and the column is sealed.
Novasep is a global supplier of sustainable and cost-effective manufacturing solutions for the pharmaceutical industry, as well as molecules for biopharmaceutical and fine chemical applications.
From the development to industrial scaling stages, we offer a complementary range of good manufacturing practice (GMP) services and equipment for purification. Our customisable chromatography equipment can assimilate flawlessly into any procedure.
Functioning as both an equipment supplier and drug substance supplier, we have deep insight into the performance drivers and challenges of biopharmaceutical and pharmaceutical manufacturing – minimising cost of goods (CoG), recipe management, time-to-market, quality control and monitoring strategy.
This dual proficiency allows us to embed these requirements for optimal efficiency in development and manufacturing procedures.
HPLC solutions for API purification procedures
State-of-the-art, exclusive Prochrom® skids are developed for intermediate polishing and purification of active pharmaceutical intermediates (APIs), insulin, peptides, cannabinoids, oligonucleotides, among others.
Hipersep® Pilot is our innovative compact, module and ergonomic system, which is designed to minimise sanitary cross-contamination risk. With more than 1,000 possible configurations, it can be easily integrated with any procedure.
Cyclojet is a novel chromatography procedure designed for optimum productivity, especially in circumstances of partial batch process resolution.
Dynamic axial compression columns
Novasep is also a revolutionary provider of dynamic axial compression columns for pharmaceutical applications, delivering a comprehensive range from lab to industrial-scale ID columns, guaranteeing the best packing performance whatever the stationary stage.
Varicol® is a multicolumn continual chromatography concept suited to large-scale separation of binary mixtures, as well as fractionation of complex mixtures, designed to adapt flawlessly to specific user requirement specifications.
We can also combine our chromatography equipment with automated solvent recycling technology upon request, enabling recovery of up to 99% of the solvent in both gradient and isocratic conditions, dramatically reducing environmental footprint, as well as operating costs.
Process intensification and downstream bioprocessing capabilities
Novasep has years of experience in the design, development and operation of continuous manufacturing processes.
We built one of the most comprehensive Food and Drug Administration (FDA) audited commercial-scale continuous chromatography platforms. To adapt to current biopharma challenges, we are committed to offering expertise and knowledge in continuous chromatography with BioSC™ Sequential Chromatography Platform.
Novasep BioSC technology accommodates for all requirements in the area of biologics purification. From the process development phase to industrial-scale operations, the first-of-its-kind technology offers multiple multi-column procedures, as well as downstream process step integration.
Furthermore, the BioSC equipment family can work three chromatography separations continuously and simultaneously, including buffer preparation and viral inactivation.
Along with producing specialised equipment, we also operate them in multiple Novasep-certified manufacturing plants.
Our experiences enables us to:
- Help in decreasing equipment qualification timeframes
- Dispatch a cGMP-trained team to perform qualification tests
- Document all qualification process steps with particular protocols, tests and reports
- Support clients throughout the entire equipment lifecycle
- Identify repairs and spare parts portfolio
- Uphold equipment excellence
- Provide appropriate application training to enhance the purification process
- Deliver service agreements for all equipment
- Train and educate operators and teams in practice and theory
- Process development support
For the outstanding efficiency and scalability, high-performance liquid chromatography (HPLC) has been widely used for purification of high-quality APIs and intermediates in the pharmaceutical industry.
Pharmaceutical manufacturers have begun to wield some new tools, nailing down new efficiencies and better drugs in the process.
The development and production of pharmaceutical drugs are driving new requirements and change the way pharma producers are selecting and using their equipment - more complex molecules, increased regulatory constraints, sanitary design, separation performance, time to market and price pressure drive outsourced production.