Enteris BioPharma Releases White Paper Reviewing Safe Handling and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAPIs)

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Facilities and processes are critical to protecting workers and the environment, says Drug Development & Delivery article

BOONTON, NJ, June 7, 2022 /PRNewswire/ — Enteris BioPharma, Inc., a biotechnology company developing innovative pharmaceutical products based on its proprietary delivery technologies, and a wholly owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), today announced the publication of a new white paper titled “Protecting Workers and the Environment: Facilities and Processes Critical to the Manufacture of Highly Potent Drugs”.

The article, co-authored by Angelo Consalvo, Director of Manufacturing for Enteris BioPharma, demonstrates how specialized knowledge, processes and facilities can lead to safer manufacturing of High Potency Active Pharmaceutical Ingredients (HPAPIs) – a rapidly growing segment within the pharmaceutical industry. The white paper can be downloaded via Drug Development & Delivery at https://drug-dev.com/whitepapers/whitepaper-protecting-workers-and-the-environment-facilities-and-processes-key-to-safely-making- very-potent-drug-products/.

“HPAPIs require specialized manufacturing capabilities to ensure compounds are contained within the facility and employees are protected from exposure,” Consalvo said. “As a result, there is a dearth of US-based facilities capable of handling the manufacturing of HPAPI pharmaceuticals, given the need for specialized containment technologies and HVAC systems. Adding to the challenge, the COVID-19 pandemic has disrupted supply chains and drugmakers are assessing the need for US-based partners to ensure they can bring drugs to market without the logistical bottlenecks. »

Consalvo continued, “Enteris’ newly renovated manufacturing facility provides an opportunity to leverage these industry-wide gaps in HPAPI oral solid pharmaceutical manufacturing, handling and expertise. In particular, we are a CMO optimized for the needs of pharmaceutical and biotechnology companies that need small batch volumes of clinical trial material while possessing the manufacturing muscle to rapidly scale for larger clinical programs and commercial activities and more advanced. »

Enteris BioPharma has completed the renovation of its Boonton, New Jersey manufacturing facility, which now includes a state-of-the-art 32,000 square foot facility with multiple suites dedicated to HPAPI handling/containment and solid oral dose manufacturing. This technical capability is complemented by our experience and knowledge of working with HPAPIs and low dose formulations to achieve excellent content uniformity.

About Enteris BioPharma

Enteris BioPharma, Inc. is a wholly owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH) providing comprehensive integrated contract development and manufacturing (CDMO) services for innovative formulation solutions utilizing its proprietary drug delivery technologies , Peptelligence® and ProPerma®, and contract manufacturing services (CMO) 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. In addition, Enteris BioPharma is advancing an innovative in-house product portfolio of drugs that address important unmet clinical needs for which there are no satisfactory treatment options. For more information about Enteris BioPharma and its proprietary oral drug delivery technologies, please visit http://www.EnterisBioPharma.com.

SOURCEEnteris BioPharma, Inc.


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