High Potency Drug Manufacturing: Molecule to Market
Read our insightful whitepaper which examines the process of successfull high potency drug manufacturing and delivery to market
PCI Pharma Services has invested in state-of-the-art containment equipment and created a ‘Potent Passport’ philosophy to identify the specific handling requirements for any Highly Potent Active Pharmaceutical Ingredients (HPAPI) project. Backed by 30 years’ experience of managing potent molecules, PCI Pharma Services is the logical choice when selecting an outsourcing high potency drug manufacturing partner.
The pharmaceutical landscape continues to evolve, with much R&D focusing on more specialized medicines. As the biological activity and specificity of the API increases, dosage strengths decrease – resulting in increased potency of the APIs in terms of occupational handling for drug product manufacture. At PCI, we are seeing continued investment in R&D with a visible shift towards speciality/potent medicines, with oncology being a particularly intense area of focus for the global pharmaceutical market. Latest data suggests approximately 25 per cent of New Chemical Entities (NCEs) in development are deemed potent.
With this evolving landscape, pharmaceutical product developers and manufacturers have had to rethink their approach, as greater potency medicines generate increasingly complex regulatory requirements. With such a significant proportion of new drugs in development containing high potency APIs, the processing of such molecules presents many challenges, not least of which is the need for significant investment in specialised containment resources to ensure that employees and their environment are protected from exposure to these drug compounds.
Contact us about High Potency Drug Manufacturing here. Let’s talk future
Please feel free to contact the PCI team [email protected]
Download and read our insightful whitepaper which examines the process of successfull high potency drug manufacturing and delivery to market
More about Our High Potent Manufacturing service
Our specialized high potent manufacturing expertise is built on 35 years experience in potent processing and offers a purpose-built facility utilizing the very latest in containment technology. This enables the safe development and clinical and commercial supply of products with an occupational exposure limit (OEL) as low as 0.01µg/m 3 .
When it comes to pharmaceutical and biopharmaceutical supply chain expertise who do you trust?
Your bridge between life-changing therapies and patients
Whitepaper! The process of successfull high potency drug manufacturing and delivery to market. Rely on us for Excellence in Drug Manufacturing & Development
High Potent API Resource Center
Experience with High 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.
Pii’s ability to handle High Potency API (HPAPI) & Cytotoxic drugs sets us apart from other CDMO’s. Our scientists' work is above cGMP standards.