Veranova has a long history of providing preparative chromatography solutions. We have the specialist expertise and equipment necessary to support your needs, from impurity isolations to production scale purifications, all to GMP standards.

Our separations team work closely with our analytical, chemical development and solid form experts to offer a fully integrated approach. Whether you need to quickly purify your API to FDA standards, or identify impurities to improve processes for scale-up, Veranova can help.

Our full scope of chromatography instrumentation and techniques enable us to provide separations at every step along your drug development journey from grams to metric tons for GMP manufacture. We purify an extensive range of APIs from amorphous solids and lipids, to drug polymer conjugates, ADC linker/warheads, 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)

Screening and Method Development

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.

 

Impurity Isolations

Our expertise in impurity isolations has proven valuable to our manufacturing team and clients alike. We can isolate and identify impurities from your intermediates and APIs removing any ambiguity. Our team of process chemists can then synthesize them for use as markers in your analytical investigations.

Post purification, our extensive analytical expertise allows us to accurately identify your unknown impurities. Veranova’s analytical instrumentation includes: NMR, MS, UV-Vis, FTIR, Raman, XRPD and polarimetry.

 

Controlled Substances

At Veranova, we have over 50 years experience in the development and manufacture of controlled substances and can provide chromatography support and expertise in this area. We perform purification of controlled substances at manufacturing scale and are licensed for Schedule I-V compounds. Veranova has an excellent relationship with the Drug Enforcement Administration (DEA).

 

Purifications

Veranova’s team of separation scientists are skilled at developing efficient purification methods for scale-up at development, kilo lab and manufacturing scale to achieve high purity APIs at every step of your process. We are able to provide GMP purifications across a full range of chromatography techniques at every scale.

 

Diagram to show different purification techniques

Diagram to show different purification techniques

Chiral Separations

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.

 

Purifications for Highly Potent APIs (HPAPIs)

Veranova has extensive expertise in HPAPI development, manufacture and purifications. Our toxicologists carry out rigorous safety assessments for all processes to ensure the correct controls are in place to safely handle potent compounds. Veranova has developed HPAPI purifications on six ADC programs and currently purifies HPAPIs at every scale from the development labs to manufacturing.

 

Veranova 1.2m chromatography column and processing infrastructure

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.

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