Antiva Biosciences develops creatively designed therapeutics that dramatically improve health outcomes for patients suffering from diseases caused by HPV. Averica Discovery worked with Antiva to provide specialist contract research services.
Here we sit down with Mike Wallace, Director, Pharm Dev and CMC Project Mgmt at Antiva Biosciences to discuss his experience of working with us.
MW: We worked with Averica to force degrade an API. The scope of work included analytical method development, force degradation and tentative structural assignments based on impurities’ molecular weights. The project was outsourced because a specialist analytical CRO was required, and the Averica team had the right set of skills to address the problem.
AVE: Why was this project important?
MW: An understanding of degradation mechanisms and the impurities that form via degradation pathways is a required component of an IND and eventually the NDA. A failure to understand how degradation impurities form presents a lack of control with respect to consistent API manufacturing. A perceived lack of control within API manufacturing could lead the FDA to raise questions on a sponsor’s IND and perhaps later reject an NDA, which could be devastating.
AVE: Why did you choose Averica?
MW: The Averica team had the right set of skills and knowledge to address the problem. Additionally, the Averica team was proactive during initial meetings, and presented a clear strategy for accomplishing the project goals.
AVE: What is your overriding impression of working with Averica?
MW: Partnership – The Averica team understood the scope of the problem. As a result, they were flexible and responsive. The collaboration was therefore productive. They also stayed within the project budget and executed on the agreement in terms of deliverables and estimated timeline. Project results and the Averica team’s execution of the scope of work either met or exceeded expectations. The Averica team’s high-quality results allowed us to develop a phase appropriate understanding of our manufacturing process capabilities and has allowed us to confidently move forward with our next phase of manufacturing process development. We would not hesitate to collaborate on another project with Averica.
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