High Potent Manufacturing
High potent drug products are an ever-expanding field of focus in our industry. High potent active pharmaceutical ingredients (HPAPIs) are effective at much smaller dosage levels than traditional APIs, but their potent characteristics present a unique set of challenges and safety concerns. A manufacturer must handle potent compounds in a carefully contained manner with appropriate safety precautions throughout drug product manufacturing. Similarly, they must also be able to scale-up these processes to produce late phase and commercial quantities.
Recro® uses a 5-band classification system based on Occupational Exposure Limits (OEL). We can handle compounds with OELs ranging from greater than 500 µg/m3 to as low as 0.1 µg/m3 (Category 1-3B). Our EH&S department and toxicologist will evaluate your compound, classifying it into one of those 5 bands according to the hazards it presents. This guides us in our determination of the equipment train, manufacturing site, and necessary containment and safety measures needed to safely handle your compound.
Why Partner With Recro for High Potent Manufacturing?
Recro has a history of success with handling potent compounds, from early development formulations to scale-up and late phase products. We work closely with our clients to ensure safe and efficient product development and manufacturing for the highest probability of success. At Recro, we have the tools and expertise needed to take your project from start to finish:
- Capacity, skill, and experience to take your project from development to clinical trials from scale-up to registration, process validation, and commercialization
- Focused, collaborative, and dedicated team to take you from start to finish, maintain, and deliver right the first time
- High-caliber Project Managers dedicated to ensuring that project deliverables are completed and timelines are met
- Appropriate and complete risk assessments and regulatory guidance
- Process improvements, efficiencies, and equipment design
- Complete supply chain assessment and risk mitigation planning
- Landlocked location, out of reach from potential severe weather, like hurricanes
- Sustainability mindset minimizing the impact of manufacturing on the environment
Interested in learning more about how Recro can help you manufacture your high potent drug product? Contact us now!