Analytical Method Development

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

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.

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.

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.

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

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.

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].