Vera pharmaceuticals

 Selecting the optimal solid form of an API during early drug development can mitigate the risk of failure later in development. This can be achieved through polymorph, salt and cocrystal screening. Polymorph screening  aims to identify all relevant forms of an API, investigate their properties and choose the optimal crystalline form. Polymorphism control is exceptionally important and conducting these screens can help prevent the appearance of new forms in the latter stages of development. We focus on establishing the interconversions between forms, the relative stability of forms and understanding the monotropic or enantiotropic relationship between polymorphs when required. Polymorph screening is a regulatory requirement whether a salt, cocrystal or free form compound is chosen for development. Salt screening  is an approach to quickly identify and assess the salt forms of an API. This allows drug developers to modify the physical properties of an API while preserving ...

  Developing a robust crystallization process to isolate the optimal solid form of an API is an essential step in API development. Identifying the crystallization approach, solvent system(s), controlling form, crystal habit and delivering a consistent uniform PSD from a single process step can be very challenging. Applying expertise in, solid state, PAT and computational modelling all underpin our development of crystallization processes, allowing us to deliver the best outcome at the required scale. We also work on remediating existing crystallizations, which can have a variety of issues such as oiling out, isolating the wrong polymorphic form or just long filtration times. Understanding the crystallization behaviour of a molecule can help: Maximise process yields Improve purity Control form, morphology and particle size distribution Create processes suitable for transfer and scale-up Strengthen IP The key to controlled, growth-dominated crystallization is a thorough understanding...

  Our scientists and engineers develop synthetic processes to enable rapid, phase-appropriate product development and commercialization. Our team has expertise in synthetic organic chemistry, physical organic chemistry and particle engineering. We also have expertise in chromatographic separations from analytical to commercial scale purification. Our commitment to state-of-the-art development utilizes a wide array of equipment and tools: Reaction kinetics modelling In-line reaction monitoring and particle visualization Flow-chemistry from bench to commercial scale Chemistry automation using Mettler-Toledo Easymax and Optimax systems Process optimization and criticality determination using advanced DoE modelling HPAPI development Thermal hazard assessment utilizing Mettler Toledo RC-1

  We foster a culture of quality and continuous improvement that not only meets the expectations of regulators and customers, but also enables business and provides a competitive advantage. Verapharma quality organization is functionally independent from manufacturing operations, safeguarding unbiased quality decisions. In addition to local quality units, we have a global quality organization that provides governance and guidance to the local quality units, and partners with all relevant functions across the organization to foster a culture in which quality is affirmed as a business enabler and a source of competitive advantage. Our GMP manufacturing sites operate in compliance with applicable regulations, local laws and international guidelines adopted by the various Health Authorities. Compliance at Verapharma is continuously monitored through regulatory inspections conducted by Health Authorities, including FDA and MHRA, quality system audits conducted by our customers, as well ...