Enteris BioPharma Publishes White Paper Examining Safe Handling and Manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI)
Enteris BioPharma, a subsidiary of SWK Holdings (Nasdaq: SWKH), has published a white paper titled "Protecting Workers and the Environment: Facilities and Processes Key to Making Highly Potent Drug Products." The paper highlights the importance of specialized knowledge and facilities in manufacturing highly potent active pharmaceutical ingredients (HPAPIs). The recent renovation of Enteris' Boonton, NJ facility enhances its capabilities in HPAPI handling. Given the current shortage of U.S.-based facilities for HPAPI production, Enteris aims to address industry challenges through its advanced manufacturing capabilities.
- Completion of a 32,000-square-foot renovated facility in Boonton, NJ, enhancing HPAPI manufacturing capabilities.
- Ability to cater to the needs of pharmaceutical and biotech companies requiring small batch volumes for clinical trials.
- Current shortage of U.S.-based facilities capable of manufacturing HPAPIs complicates market entry for potential partners.
- Supply chain disruptions caused by the COVID-19 pandemic may impact business operations and timelines.
Facilities and processes key to protecting workers and the environment, the paper in Drug Development & Delivery says
BOONTON, N.J., June 7, 2022 /PRNewswire/ -- 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, "Protecting Workers and the Environment: Facilities and Processes Key to Making Highly Potent Drug Products."
The paper, coauthored by Angelo Consalvo, Director of Manufacturing for Enteris BioPharma, demonstrates how specialized knowledge, processes and facilities can lead to safer manufacturing of highly potent active pharmaceutical ingredients (HPAPIs) – a fast growing segment in the pharmaceutical sector. The whitepaper is available to download via Drug Development & Delivery at https://drug-dev.com/whitepapers/whitepaper-protecting-workers-and-the-environment-facilities-and-processes-key-to-safely-making-highly-potent-drug-products/.
"HPAPIs require specialized manufacturing capabilities to ensure that the compounds are contained inside the facility and that employees are protected from exposure," Consalvo said. "As a result, there is a shortage of U.S.-based facilities that can handle manufacturing of HPAPI drug products, given the need for specialized containment technologies and heating, ventilation and air conditioning systems. Adding to the challenge, the COVID-19 pandemic has disrupted supply chains and drug makers are assessing the need for U.S.-based partners to ensure they can bring medicines to the market without the logistical logjams."
Consalvo continued, "Enteris' recently renovated manufacturing facility provides an opportunity to capitalize these industry-wide shortcomings in HPAPI solid oral drug product manufacturing, handling and expertise. In particular, we are a CMO optimized to the needs of pharmaceutical and biotech companies that require small batch volumes of clinical trial material while possessing the manufacturing muscle to quickly scale for larger, later-stage clinical programs and commercial activities."
Enteris BioPharma completed the renovation of its Boonton, NJ manufacturing plant, which now encompasses a 32,000-square-foot, state-of-the-art facility with multiple suites dedicated to HPAPI handling/containment and solid oral dose manufacturing. This technical capacity is complemented by our experience and knowledge working with HPAPIs and low-dose formulations to achieve excellent content uniformity.
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH) offering total integrated contract development and manufacturing (CDMO) services for innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®, and contract manufacturing (CMO) services using non-proprietary technologies. The company's proprietary technologies have been the subject of numerous feasibility studies and active development programs, some 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 oral drug delivery technologies, please visit http://www.EnterisBioPharma.com.
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SOURCE Enteris BioPharma, Inc.
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