Paper Examines the Opportunities and Challenges in Working with High Potency APIs
Boonton, NJ, November 02, 2021 — Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), announced today the publication of a new white paper entitled, “HPAPI Drug Solid Oral Dosage (SOD) Manufacturing – Power, Precision and Productivity.”
The paper, which is available through Contract Pharma magazine, provides insight into current trends and important issues drug makers face when outsourcing the manufacture of solid oral drugs with high potency active pharmaceutical ingredients (HPAPI), including the criteria that must be considered when selecting a contract development and manufacturing organization (CDMO).
“HPAPIs are one of the most rapidly growing segments of the drug development industry because such drug products can provide exponentially greater potency than a traditional pharmaceutical agent while using a fraction of the drug substance,” said Paul Shields, Ph.D., Chief Operating Officer of Enteris. “However, this same power and potency pose challenges to their manufacture, and their low dosages often require specialized formulating technologies when developing solid oral dosage products. Given this, pharmaceutical companies need to be certain that their CDMO is equipped to work with such challenging APIs, including both the expertise and equipment to ensure safe, efficient and precise production. This is especially the case when developing solid oral dosage HPAPIs.”
Dr. Shields continued, “Enteris BioPharma recently completed the renovation of a state-of-the-art facility that includes approximately 2,500 square feet dedicated to HPAPI handling/containment and SOD manufacturing. This technical capacity is matched by an unparalleled know-how in developing immediate- and modified-release SOD forms, including tablets, minitablets and capsules, for non-potent and highly potent APIs, alike. We are excited to share our knowledge in this white paper and welcome the opportunity to work with both large pharmaceutical companies and smaller biotechs to service their HPAPI needs.”
The whitepaper at https://rodpub.com/email/cp/LandingPage/Enteris/Enteris_Whitepaper.html.
About Enteris BioPharma
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH) offering total integrated contract development and manufacturing (CDMO) services including innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®. The technologies have been the subject of numerous feasibility studies and active development programs, several of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option. For more information on Enteris BioPharma and its proprietary drug delivery technologies, please visit www.EnterisBioPharma.com
For Enteris Biopharma:
Kalpana Ramakrishnan, Ph.D.,
Manager, Business Development
+1.862.261.9125
For Media Relations:
Jason Rando
Tiberend Strategic Advisors, Inc.
+1.212.375.2665
jrando@tiberend.com