High Potency APIs (HPAPIs)
Quotient Sciences can help you develop your highly potent compound. We have many years of expertise in developing and manufacturing high-potency APIs (HPAPI's) and compounds.
Our global facilities are configured with the necessary controls required for the handling and processing of highly potent molecules and we offer our customers a complete, global end-to-end development solution from early-phase formulation screening through clinical and commercial manufacturing.
High Potency Drug Development & Manufacturing
Highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly common in drug development pipelines. This is especially true in the oncology sector for example, as researchers look for therapies that have greater selectivity and pharmacological activity.
HPAPIs present an array of additional CMC challenges, mainly due to the containment requirements that protect both the operators and manufacturing facilities. HPAPIs production processes usually also require a greater level of precision and control due to the very small quantities of drug present in the final dosage form.
High-Potency API Handling
Using Quotient Sciences experience and expertise across the industry drug development pipeline, we have actively responded to the challenges associated with the manufacturing of today’s high-potency drug products. We have ensured and invested in our state-of-the-art facilities so that they are capable of handling compounds with a maximum performance-based level of exposure classification for our customers.
If you have any questions relating to how we handle HPAPIs please don't hesitate to bet in touch wioth our team of scientific experts who will be happy to assist you with your highly-potent drug development challenges.
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Info SheetGlobal Formulation Development and Manufacturing CapabilitiesWe provide full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.
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Info SheetHigh Potency HandlingWith over 30 years of experience in small molecule drug development, Quotient Sciences possesses the expertise to overcome the challenges that arise with HPAPIs.
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Scientific PostersASCP 2023: A Phase 1 SAD and MAD Trial of EVX-101, a Novel Gastro-Retentive Prolonged ReleasePresented at ASCP 2023, "A Phase 1 SAD and MAD Trial of EVX-101, a Novel Gastro-Retentive Prolonged Release". Find out about how Quotient Sciences can help accelerate your drug development program.
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Scientific PostersEuPFI: Taste Assessment Study of Tenapanor Pediatric Solution FormulationsPresented at EuPFI 2023, "Taste Assessment Study of Tenapanor Pediatric Solution Formulations".