Veranova has a legacy of excellence in the separation and purification of drug substances. From impurity isolations to production-scale purifications, we have the expertise and equipment to support your needs.

Our full scope of instrumentation and techniques for chromatography, tangential flow filtration, and crystallization enable us to provide separations at every step along your drug development journey – whether you need to quickly purify your API to FDA standards, or identify impurities to improve processes for scale-up.

During this crucial stage of development, our separations team works closely with our analytical, chemical development and solid form experts. Leveraging this fully integrated approach, we purify an extensive range of APIs, including amorphous solids and lipids, drug polymer conjugates, ADC linker/warheads, and peptides and nucleoside analogs.

  • Method development to identify modalities and optimum separation conditions
  • Purifications – normal phase, reverse phase and supercritical fluid chromatography (SFC)
  • Chiral separations of starting materials, catalysts, intermediates and APIs
  • Impurity isolations, purifications and synthesis – nuclear magnetic resonance (NMR), mass spectroscopy (MS), and spectroscopies (Raman, IR and UV) are available for post purification analysis and identification
Download our Chromatography Flyer (2.7 MB)

Chromatography

Veranova has the latest in preparative chromatography technologies. We have fully automated screening by SFC and high-performance liquid chromatography (HPLC), enabling us to quickly assess the most effective instrumentation and modalities for your chromatography scale-up needs. At Veranova a diverse range of chromatography stationary phases, solvents and modifiers can be rapidly screened to enable quick development of optimal preparative separation conditions for all types of APIs. Our MS-coupled instrumentation enables our team of expert scientists to tackle purification of molecules without a chromophore.

Veranova can perform chiral separations for starting materials, catalysts, intermediates, and APIs. Veranova’s SFCs are ideal for manufacturing scale chiral separations. SFC is an excellent high–throughput technique for identifying optimal chiral separations methods. Using supercritical CO2 as a solvent allows SFCs to operate at much higher flow rates than HPLC giving quicker cycle times. The majority of SFC methods are isocratic which allows stacked injections which accelerate the purification times even further.

 

Diagram to show different purification techniques

Diagram to show different purification techniques

 

Veranova 1.2m chromatography column and processing infrastructure

Tangential Flow Filtration

Veranova’s tangential flow filtration (TFF) capabilities span from process development to small-scale GMP manufacturing. At the research stage, we provide a TFF system that allows for efficient concentration and buffer exchange for small volumes. This setup helps the development of an efficient process that can be scaled up. For scale-up, Veranova offers GMP-qualified systems to support purification strategies. Our separations team delivers reproducible results and streamlined workflows. Veranova’s TFF capabilities support process developments and GMP small-scale manufacturing with the highest standards of quality.

Crystallization

During drug development, establishing a robust crystallization process to isolate the optimal solid form of an API is essential. At Veranova, we apply our expertise in solid state, PAT and computational modelling to purify your drug substance with confidence. We also work on remediating existing crystallizations, which can have a variety of issues such as oiling out, isolating the wrong polymorphic form or long filtration times.

Veranova’s crystallization development can help you:

  • Improve purity
  • Control form, morphology and particle size distribution
  • Create processes suitable for transfer and scale-up
  • Strengthen IP

HPLC

HPLC allows Veranova to produce and deliver high purity APIs at every step of the drug development process for even the most challenging compounds. HPLC can be a valuable tool to isolate and identify hard-to-ionize impurities.

Agilent 1290 preparative HPLC-MS (1 – 100+ g)
YMC K-Prep 1500G (100 g – 20 kg)

Lab scale preparative HPLC-MS

MPLC Dynamic Axial Compression (DAC) columns

Veranova has DAC columns available for every scale of your GMP manufacturing purification needs. Veranova’s team of purification scientists are skilled at optimizing purification methods, ensuring you get the maximum loading and highest purity possible for every compound we chromatograph.

50 cm diameter (30+ kg)
1 m diameter (100+ kg)
1.2 m diameter (200+ kg)

1.2 m DAC MPLC column

DAC (MPLC) column

 

Automated MPLC chromatography instruments

Veranova is equipped with Automated MPLC Column Purification Systems (Biotage Teledyne) for every scale allowing consistent scale up from development to manufacturing scale.

CombiFlash NextGen 300+ (10 mg – 150 g)
CombiFlash Torrent (0.5 – 750 g)
Biotage 400 (1 – 8 kg)

MPLC flash columns (kilo lab scale)

Our MPLC flash columns allow us to quickly scale up your development chromatography in our GMP kilo labs giving you rapid access to material while we help you optimize your chromatography for large scale production.

30 cm diameter (500 g – 3 kg)

 

SFC

Our expertise in SFC coupled with our range of instrumentation allows Veranova to purify or chirally separate your most challenging molecules quickly and efficiently at every scale.

SFC is typically thought of as a normal phase technique. However, with the usage of additives and in some instances water SFC can elute molecules typically thought of as ‘too polar’ for normal phase.

Shimadzu Nexera preparative SFC (10 mg – 100+ gs)
Novasep 20/30 (10 mg – 100+ gs)
Novasep Supersep 100 (1 – 10 kg scale)
Novasep Supersep 200 (10-100 kg scale)

 

Lab scale SFC

Lab scale SFC

Post-separation processing and solvent removal for isolations

Veranova has an array of equipment for post separation solvent.

  • Thin film evaporators allow rapid solvent removal for API isolation and solvent recovery
  • Lyophilizers, for heat sensitive APIs and hard to isolate solids
  • Large scale rotary evaporators for solvent removal in the development and kilo labs
  • Solid phase extraction allows on-column separation and concentration
  • Crystallization

Veranova’s analytical team offer complete analytical characterization and QC testing to meet GMP requirements.

CDMO Services

Solid Form and Particle Engineering

Process and Analytical Development

Custom API Manufacturing

Specialty Modalities

Veranova is your next great decision

Discover new ways to advance your science with Veranova.

Contact us