Highly Potent Drug Product Manufacturing
The professionals at Pii have the experience and knowledge, supported by effective containment controls, rigorous quality systems, and state-of-the-art equipment, to quickly advance your HPAPI from concept to clinic to commercialization.
Highly Potent API Resource Center
Experience with Highly Potent API & Cytotoxic Drug
Pii operates with a quiet confidence that comes from years of experience with HPAPI and cytotoxic drug products. 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 of your project, regardless of where you are in the development process. In most cases, we will deliver a proposal to you within 3 to 4 days that includes:
- A high-level work scope, cost estimate, and timeline along with a summary of activities to be conducted to ensure a successful integration of the program from you to Pii.
- Special equipment requirements, if any.
- A concept of how we will work with you to fully understand the safety information for your compound.
- Assessment of the level of containment needed to ensure your project can progress on time and on budget.
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 manufacturing containment suites are equipped with state-of-art-technology that prevents exposure and cross-contamination risk, and in some cases eliminates the risk of manual intervention with your drug product. Additionally, operating beyond the requirements of GMP 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 a 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 with our Concept-to-Clinic-to-Commercialization Pharmaceutics Know-How™