Highly Potent API Manufacturing
The professionals at Pii have the experience and skills, supported by effective quality systems and state-of-the-art equipment to quickly advance your highly potent active pharmaceutical ingredient (HPAPI) from concept to commercialization.
Highly Potent API Resource Center
Experience with Highly Potent API & Cytotoxic Drug
When it comes to HPAPI, you will notice that we operate with a quiet confidence that comes from years of experience with HPAPI and cytotoxic drug products.
At Pii we have learned that every successful HPAPI project begins with a deep understanding of the data. That is why before we even present you with a contract, we conduct a comprehensive technical assessment regardless of where you are in the development process. In most cases, within 72 hours we will deliver a proposal to you that includes:
- A high-level estimate and timeline along with a summary of activities to ensure a successful integration of the program between our valued partners and Pii
- Special equipment requirements
- Defined facility resources for the project
- A concept of how we will work with you to fully understand the safety information of your compound to ensure undisrupted progress for your project
HPAPI & Cytotoxic Drug Safety
HPAPI and cytotoxic drugs present a significant inherent risk to operators and patients if not handled, manufactured, and packaged properly. That’s why our analytical and manufacturing suites are equipped with state-of-art-technology that lowers the risk, and in some cases eliminates the risk of manual intervention with your drug product. Additionally, operating beyond the requirements of cGMP to prevent cross-contamination is our standard.
Quality is the cornerstone for operational excellence and at Pii continuous improvement is part of our DNA. Each of our operators is empowered to function as the head of quality. Everyone must know what to do, why they are doing it, and why it matters. If they cannot answer those three questions with confidence, they have the authority to pause and gain the understanding they need.
HPAPI & Cytotoxic Capabilities
Our capabilities span the entire drug development lifecycle. Whether you are at the pre-IND stage or needing a partner to help you scale-up manufacturing for batches to support a clinical trial, Pii is ready to support you all the way to and through commercialization.