All posts by saaron

Epione Formulation Performs Well in Safety, Stability Testing

Avomeen Analytical Services has completed the majority of the safety and stability testing of the Epione formulation. The formulation has successfully passed analytical tests to measure crystallization of the drug combination, in both real-time and forced  stability testing at room temperature. These successful results mean that the formulation is safe and stable at room-temperature.

Complete results are available upon request.

Epione FDA Status Update

Epione Biopharmaceuticals recently completed an informal meeting with the FDA. Dr. Patricia Love, Deputy Director of Combination Devices Division at the FDA, met with the Epione team November 9, 2016. During the meeting, Dr. Love informally affirmed that the anticipated pathway using surrogate data on its existing APIs could allow approval in as little as 6-10 months.

Innovative Clean Room System Selected for Epione Manufacturing Facility

Epione Biopharmacueticals engages AES Clean Technology, Inc. to provide multiple modular cleanroom systems to house the Vanrx SA25 Aseptic Workcell(s).  The installation of the SA25’s in the modular clean rooms will give Epione the ability to create and maintain a cGMP compliant facility with ease of construction, installation and maintenance due to the modular nature of the AES Clean Technology solution.

About AES

AES is the leader in turnkey design, manufacturing, and construction, of modular cleanroom systems, and builds custom cleanroom equipment for life science and technology companies. In-house AES cleanroom experts include technical and professional staff to manage cleanroom projects from concept design through construction, commissioning and turnover.

AES specializes in modular systems because modular cleanroom technology delivers more speed, cleanliness, quality, and repeatable performance to your cleanroom project.  Predictable finishes, costs, and schedule add value to every dollar of the investment delivering the highest value to facility operations and ensuring quality for years to come.  The AES Modular Cleanroom Systems also makes it easier to upgrade, retrofit, and expand your existing cleanroom facilities.

www.aesclean.com

Preliminary Design of Epione Manufacturing Facility Completed

Epione Biopharmaceuticals has completed the preliminary design of its corporate headquarters and manufacturing facility led by Mr. Jeff Milligan, PE of Spokane, WA. Mr. Milligan is an industry leader in advanced pharmaceutical and biotechnology facility design focused on injectable products including but not limited to small molecules, biologics, and lyophilized products.  One of his crowning achievements was completing the design and validation of the Symlin Pen manufacturing facility.  He is also an expert on robotic filling systems, as well as standard pharmaceutical line design.

Epione Pharmaceuticals Selects OMPI as Cartridge Vendor

Epione Biopharmaceuticals and OMPI entered into a partnership in which OMPI will provide 3mL nested cartridges for use in the Vanrx SA25 Workcell in Epione’s cartridge filling operation.

About Ompi

Ompi is the Pharmaceutical Systems division of the Stevanato Group. It has more than 65 years’ experience in the production of glass primary packaging for the pharmaceutical industry: ampoules, vials, cartridges and syringes.

Ompi is well positioned to serve the future needs of its clients with production sites located throughout Europe (Piombino Dese-Padua and Latina in Italy, Bratislava in Slovakia). In addition, there is also a plant in Monterrey, Mexico that is supported by a commercial office in the USA, a greenfield facility in Zhangjiagang, China and a new commercial office in Sete Lagoas, Brasil with a plant under construction.

www.ompipharma.com

Epione Forms Injection Device Partnerships

Epione Biopharmaceuticals and Owen Mumford of England began talks on providing a version of their pre-certified Autopen for use in Epione Biopharmaceutical’s injectable drug candidate for Abortive Migraine Relief.

ABOUT OWEN MUMFORD

Owen Mumford has been at the forefront of medical device innovation for over 60 years, creating solutions that improve the delivery of healthcare and home health treatments for people around the world. Their products span devices that make blood testing more comfortable to solutions that make it easier to administer life-saving medication.

Their experience in medical devices began in the 1950s when founders Ivan Owen and John Mumford established the company. Today, they have direct sales offices and a network of distribution partners serving customers in over 60 countries, and employ over 700 people across the Americas, Europe and Asia.

www.owenmumford.com

Epione Biopharmaceuticals Selects Innovative Manufacturing Solution

Epione Biopharmaceuticals and Vanrx began a developmental partnership to customize the SA25 workcell for use in their cartridge filling operation. Gloveless aseptic workcells like the SA25 can flexibly produce multiple products with minimal downtime. They are designed for lower volume, higher value injectables, and precise control through automation.

About Vanrx

Vanrx was started by people from biotech: developers of processes and products that formed groundbreaking therapies. Vanrx was formed to completely redesign the aseptic filling process and create the most technologically advanced fill-finish solutions for pharmaceutical manufacturing.

With Vanrx filling machines, pharmaceutical companies can bring high-value injectable medicines to market faster. The SA25 Aseptic Workcell has the agility to fill vials, syringes or cartridges, and quickly switch between products.

www.vanrx.com

Epione Biopharmaceuticals and Avomeen Labs Enter Into Development Agreement

Epione Biopharmaceuticals and Avomeen Labs entered into a development agreement to provide pre-clinical testing on multiple drug candidates in the pain space.

About Avomeen

Avomeen’s full-service product testing and development laboratory provides advanced analytical testing and innovative formulation development services.  Specialties include product testing and evaluations, chemical analysis, product failure analysis, material testing and contaminant identification, product reverse engineering, pharmaceutical analysis and development, custom synthesis, and litigation support services (intellectual property, product liability, expert witness).

Avomeen is FDA registered and GLP/GMP compliant. The lab is DEA licensed and certified ISO17025.