The French connection

Unither uses blow-fill-seal (BFS) technology to produce small, (0.3mL) to medium volume (20 mL) liquid-filled sterile unit-doses. Over the last 20 years this manufacturing technique has become more prevalent within the pharmaceutical industry, and Unither points out that it is now widely considered to be one of the top forms of aseptic processing by various medicine regulatory agencies including the US Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products.

The main advantage of this type of manufacturing is to produce preservative-free formulations. Because each individual dose is for single use and must be discarded after one administration, there is no microbiological contamination of the contents.

This preservative-free formulation is of essence when one considers the sterile content is to be generally administered on inflamed or injured mucosas (eyes, nose, ears, and lungs). However, the mucosal application is not exclusive as Unither also produces spore probiotics in suspension for oral administration.

The second advantage of BFS technology is to avoid misuse of the drug product by delivering the right dose. In the case of inhalation products for asthma (nebules), the full volume of the BFS unit-dose is the exact dose for one use. Regarding eye-drops, the BFS unit-dose usually contains no more than four to six drops (two to three for each eye).

With one R&D dedicated facility and three industrial plants - two in France and one in the USA -  inspected by a number of Health Authorities (European, US FDA, ANVISA – Brazil -, Turkish, South Korean, Middle-East), Unither provides full-development services, clinical batches and commercial products manufacturing. Unither is the only CDMO in the world able to provide such an internal network to optimise and secure the development and the manufacturing of its customers’ products.

One of the most critical services Unither provides to customers is formulation and analytical development. Unither employs pharmacists, scientists and engineers with extensive BFS development know-how to offer the best formula adapted to the ocular, nasal, pulmonary, buccal or topical delivery.

The R&D team at Unither boasts 25 years of experience in handling NCEs (New Chemical Entities) and generic drug substances, and performs early-stage pharmaceutical development for Phase I clinical trials. After a thorough understanding of the physico-chemical characteristics of the API and the consideration of the biological targets, the formulation works results in a number of formulas for screening. Several formulas are provided together with the analytical methods and pre-stability studies results. The pharmaceutical development process continues, including analytical methods validation and QC of the batches produced, until the tech-transfer to a Unither industrial site in charge of Phase I clinical batches manufacturing (active and placebo). The R&D team supports all the development process, including changes in formulation, exploration of Impurities, stability stress-tests, up to the manufacturing of registration batches, ICH regulatory stability studies and over. The close relationship with the regulatory affairs allows a rapid compiling of IMPD/NDA/ANDA or CTD dossiers and delivery to the customer.

Over the 20 past years, Unither teams have developed a wide knowledge in simple solutions, and above all, a specific expertise in more complex formulations: suspensions which exclude end-filtration sterilisation and emulsions where one of the two media cannot be heat sterilised.  

In response to an increasing customer demand for aseptic processing, Unither continues its growth on several continents with facilities in Europe, the USA, with sales offices in Brazil, and tomorrow facilities on other continents to serve local markets and end-users.

With an overall capacity of 2.5 billion doses produced by 18 Rommelag 4010 rotative and 3 alternative bottelpack machines, Unither continues bringing more BFS opportunities every year to customers worldwide with the highest-quality support systems.

Because of its high expertise in the BFS industry, Unither is able to provide cost-effective, customised manufacturing options for the most complex treatments, ensuring what it describes as a reliable global supply and an uncompromising commitment to quality.