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Vera Pharmaceuticals

 

Crystallization Development

  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...

Quality, Compliance and Regulatory Affairs

  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 ...