Since its inception in 1993, Unither Pharmaceuticals has grown to become the worldwide leader of sterile unit-dose manufacturing using blow fill seal (BFS) technology. With locations in both hemispheres, including five manufacturing plants and one R&D centre, it is globally recognised for its unique approach to developing and commercialising single-dose products that simplify the lives of patients.

Unither Pharmaceuticals manufactures more than two billion BFS vials annually. It has production facilities in Coutances (FDA inspected) and Amiens, France, and supplies more than 80 countries across Europe, the US and China. The company is actively expanding its capacity, including the installation of a new BFS facility in the US.

Expanding the lead in BFS

In October 2013, Unither acquired the former UCB Pharmaceutical facility located in Rochester, New York, US, to support its strategic plans for expansion. This FDA and DEA-inspected facility will drive growth for Unither in North America by bringing the capacity closer to the world’s largest pharma market.

The Rochester facility has expertise in developing and manufacturing oral solids and liquids, (OTC and Rx products) with extended and controlled release profiles while adding single-unit dose capabilities.

The expansion includes the installation of a BFS machine in 2015, followed by the first high-speed commercial BFS line the following year. This added capacity will support Unither’s expansion into the asthma and ophthalmic markets for preservative-free, sterile-fill liquid products in North America.

Its Coutances and Amiens facilities in France, meanwhile, will be continuing to expand the company’s BFS capacity by adding new commercial lines in 2015 and 2016. With the ability to provide capacity for unit doses of 0.25-20ml, Unither can quickly meet pharmaceutical partners’ needs in the areas of ophthalmology, respiratory, rhinology, otic care and antisepsis, or wound cleaning.

User-friendly technology

Blow fill seal technology was developed in Europe in the 1930s and was introduced to the US three decades later. BFS is a continuous, robust means of filling aseptic preparations of sterile pharmaceuticals.

Unither Pharmaceuticals has become the world’s leading expert at creating safe, accurate, and convenient dosing options. The BFS single-dose vial is currently the most popular container of its type in Europe for new ophthalmology treatments, as it eliminates preservatives, such as benzalkonium chloride, and is increasingly used when reformulating existing products. BFS vials are easy to carry and ready to use, making them a great fit for today’s active lifestyles.

They provide a number of advantages, including the ability to dispense accurate single doses without measuring devices, portability, the elimination of preservatives, and improved hygiene.

Lab to plant

Unither’s R&D team offers more than two decades of experience in developing formulations for new chemical entities (NCE), as well as established commercial and generic drug substances. Unither can support every phase of a project, from early-stage product development for Phase I clinical trials, to late-life-cycle line extensions. If desired, the team can deliver a number of formulae for screening, as well as validated analytical methods, ICH stability programmes, and clinical batches.

The R&D department continues to support the commercialisation process with the technology transfer to Unither’s production sites, which includes the manufacturing of registration batches, validation batches and regulatory stability studies.

Through the high level of cooperation, internally and externally, Unither Regulatory Affairs group rapidly compiles the EMA Investigational Medicinal Product Dossier (IMPD), FDA New Drug Application (NDA), FDA Abbreviated New Drug Application (ANDA) and/or ICH Common Technical Document (CTD) dossiers to enable customers to bring their product to the market as quickly as possible. Partnering with Unither Pharmaceuticals is the single best way to deliver your drug product to the global market.