Highly Potent API Process Research Service

Highly potent API (HPAPI) refers to a category of pharmaceutical compounds that exhibit high potency at low doses. These APIs are usually used in the development of medications for serious or complex diseases where a high level of potency is required to achieve therapeutic effects such as cancer treatments and hormone therapies. The HPAPI market is expected to continue to grow in the coming years, driven by advancements in drug development technologies and increasing demand for targeted therapies. Many companies are focusing on developing innovative HPAPI with improved efficacy and safety profiles, as well as expanding their manufacturing capabilities to meet the growing demand for these compounds. HPAPI process research is critical for pharmaceutical companies aiming to bring innovative treatments to market. At our company, we specialize in providing HPAPI process research services to pharmaceutical companies seeking to develop cutting-edge treatments. Our HPAPI process research service helps our clients navigate these challenges and streamline their operations.

Service Overview

Developing a robust and efficient manufacturing process for HPAPIs requires careful consideration of factors such as containment, environmental impact, and efficacy. Our team of experts is equipped with the knowledge and technology necessary to handle HPAPIs safely and effectively that can help our clients optimize their manufacturing processes, improve efficiency, and ensure the highest level of quality in their HPAPI products. Our services include:

• R&D of starting materials, intermediates, impurities and reference standards
• Route or step rebuild
• Synthetic route design/route scouting
• Process optimization and demonstration
• DOE, Spike, Fate and Purge studies to support process optimization and validation.
• Process safety assessment
• Qualification of reference and impurity standards
• Forced degradation (stress) studies
• Stability studies
• Cleaning validations
• Scale-up
• GMP production 1 batch

Our Dedicated HPAPI Lab

Handling highly potent APIs requires specialized facilities, equipment, and protocols to ensure the safety of workers and avoid any potential health risks. In response to this, our company offers a comprehensive HPAPI process research service through our state-of-the-art dedicated HPAPI lab. This laboratory is equipped with the latest technology and rigorous safety measures to support the research and development of highly potent chemical compounds. The lab features:

• Equipped with high-end fume hoods that are designed with negative pressure to ensure maximum containment of highly potent substances.
• Barrier isolation units to further prevent any potential contamination.
• Balance connected with an isolator allows for accurate weighing of materials without exposing workers to the substances.
• Multi-purpose solids handling suites that ensure safe and efficient processing of HPAPIs and intermediates.
• High potent analytical labs with dedicated equipment connected with a pass box to prevent cross-contamination.
• HPAPI lab incorporated a biometric access control system to regulate entry and exit into the facility, ensuring that only authorized personnel have access to the highly potent compounds.
• Capable to handle HPAPI and intermediates with occupational exposure limits (OEL) as low as 30 ng/m³.
• A strict separation of man-material entry and exit points to prevent cross-contamination.
• Mist shower facilities are available for personnel exiting the lab, further enhancing safety protocols.

HPAPI compounds are revolutionizing the pharmaceutical industry by enabling the development of potent and precise treatments for a variety of medical conditions. With our dedicated HPAPI lab and team of experts, we are well-equipped to provide cutting-edge solutions to our clients and support the advancement of innovative treatments. If your company is looking to enhance its HPAPI process research capabilities, we invite you to partner with us and experience the benefits of our expertise and dedication to excellence.

It should be noted that our service is only used for research, not for clinical use.