Our dedicated team of experts and extensive equipment capabilities enable us to deliver quality analytical methods throughout all phases of clinical development, GMP scale up and commercialization in line with ICH and FDA/MHRA/EMEA requirements.

Our technical team develop, qualify, transfer, and validate analytical methods as part of our integrated approach to process and product development. This enables full analytical support for regulatory starting materials (RSM) and in-process control strategies in addition to intermediate and API characterization with the flexibility needed for phase appropriate development and GMP manufacturing of drug candidates.

  • Method development, qualification, validation, and transfer in compliance with global regulatory guidelines/ICH Q2(R1)
  • ICH stability including photostability
  • Forced degradation studies
  • Impurity isolation, identification, and characterization.
  • Characterization of APIs and precursors
  • Reference material program
  • cGMP Regulatory Starting Material assessment
  • Potential mutagenic impurity (PMI) & nitrosamine assessment and testing

Our global analytical development capabilities facilitate the full range of analytical techniques required to test for the purity, identity, potency, chiral purity and safety of the investigational product at all clinical phases.

We use state-of-the-art spectrometry, spectroscopy, chromatography, and characterization instrumentation to deliver high quality methods to the specifications required:

  • UPLC with TUV, PDA, and QDa detectors
  • HPLC with VWD, PDA, CAD, MALS, RI, FD, and MS detectors
  • GC (direct and headspace injection) with FI, EC, and MS detectors
  • IC with conductivity and UV detectors
  • Spectroscopy (IR, NMR, ICP-OES, ICP-MS, UV/Vis, Polarimeter)
  • Physical Characterization (TGA, DSC, XRPD and Particle Size Analyzer)
  • Thermal Analysis (TGA & DSC) and Wet Chemistry (TOC, Titrators, RI)

Reference standard qualification and impurity isolation & characterization

Veranova offers a robust lifecycle approach for reference standard qualifications and
requalification by ensuring identity, strength, quality, purity, and potency.

Stability testing

Across our sites, we have over 20 stability chambers available for supporting full GMP and non-GMP studies.

Our chambers are available across all temperature zones, meeting our customers’ stability data needs and providing confidence for their marketing authorization applications. Through extensive forced degradation studies, we ensure that stability methods are fully robust and fit for purpose.

Potent compound capabilities

We carry out significant safety assessments at our Devens, MA, and West Deptford, NJ, sites, ensuring controls are in place to handle potent compounds with occupational exposure limits (OELs) down to 0.01 µg/m3 in our highly potent handling isolators and 1 µg/m3 in potent handling isolators.

Following appropriate sample preparation, potent compounds can be safely analyzed via several instruments to confirm purity and other characterization tests.

Controlled substances

We have extensive knowledge and experience in handling and testing controlled substances, providing unique insight into the critical issues surrounding these compounds, and an excellent relationship with the relevant governing agencies such as the US Drug Enforcement Agency.

As such, Veranova is a proven leader in testing controlled substances, such as opiates, amphetamines, cannabinoids, and synthetic stimulants. And our analytical teams diligently support the analysis of controlled substances in therapeutic classes including analgesia, CNS disorders, and anti-addiction treatments.

Compendial methods and assessments as per ICH requirements

Our analytical scientists have extensive expertise in performing assessments as per Pharmacopeial General Chapters and ICH Guidelines. Our experts will provide robust, quality-driven risk assessments to ensure that the regulatory requirements are met or exceeded. This includes detailed reports and assessments on:

• Screening & product specific methods
• Phase appropriate method qualification, validation & transfer
• Nitrosamine risk assessment & testing
• Elemental impurity risk assessment & testing
• Benzene risk assessment & testing
• Mutagenic impurity risk assessment & testing with the design of spike-fate-and-purge experiments

Analytical services for antibody drug conjugates (ADCs) and linkers

Our state-of-the-art equipment capabilities (LC-MS/MS, NMR, SEC-MALS, and size exclusion chromatography) provide an end-to-end characterization experience in the emerging field of ADC and linkers. We deliver phase appropriate analytical methods (development and qualification/validation) for testing drug candidates of ADCs and delivering robust analytical methods for quality control use as per the ICH requirements.

Our testing capabilities cover both functional and physiochemical properties, including in process control, release and stability indicating methods. Veranova has extensive knowledge in determining the concentration and extent of drug conjugation achieved, and distribution levels of the ADCs and linkers.

Design of experiment (DoE) capabilities

Each of our sites can conduct a statistical design of experiment (DoE) to determine initial method parameters and/or aid with robustness testing to facilitate AQBD
principles of lifecycle management [ICHQ12].

Case study

Conquering the challenging manufacture and analysis of lipidic palmitoyl ethanolamine prodrug ETX-018810, with purification and stability challenges

Veranova supported Eliem Therapeutics in the development of a new manufacturing route to prodrug ETX-018810. The synthesis presents challenges as the intermediates are lipophilic and cannot be purified by crystallization. Multiple ester functionality present stability issues and the absence of a chromophore present difficulties with analytical control.

Veranova provided chemical, analytical and solid form science development support.

  • Development of an immobilized lipase catalyzed regioselective 1,3-acylation of glycerol.
  • Identification and characterization of a crystalline dicyclohexylamine (DCA) salt of an intermediate to facilitate impurity control.
  • Process demonstration in Cambridge production laboratories to manufacture 1, 5 and 10 kg batches of ETX-018810.
  • Development of analytical methods for in-process control, intermediate and API purity measurement.

Please contact Veranova for chemical, analytical development and solid form science support for your programs.

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