Unither’s CDMO supports its customers from early stages of ophthalmic product development Anaïs CASTEX holds a Master’s degree in Formulation and Quality Analysis. She has worked in the pharmaceutical industry for over 16 years (including 14 years at Unither), first at GENEVRIER Laboratories and then GSK, and now at Unither Pharmaceuticals in the R&D and sales departments. Unither is committed to meeting the needs of its projects in their earliest stages, which has enabled the company to build a solid foundation in recent years. This has been achieved by strengthening its R&D teams and offering comprehensive regulatory services, including support with regulatory strategy, drafting and preparation of dossiers, and others. Unither has also increased production capacity at all its Blow-Fill-Seal (BFS) sites in France, the United States, and China. This has enabled the company to be better prepared for the demands of its projects, and provides the necessary foundation for continued success. Thanks to Unither’s strengthening development strategy, the CDMO is becoming a key player in the development of ophthalmic products. This is done by supporting biotechs, start-ups and development companies Our customers, agents of change Unither’s customers consist of start-ups, biotech companies and pharmaceutical development companies. They include not only small companies developing novel molecules in ophthalmology, but also pharmaceutical companies specializing in eye diseases. In addition, they include companies that already have their own multi-dose or single-dose eye drops. As well as CROs (Clinical Research Organisations), when they are in the preclinical phase, the studies will often be done in small glass vials, for ease of filling. Nowadays, startups and biotechs know that preservatives must be avoided as they have known effects. Sterile solutions are the most recommended. The difference between single and multi-dose preservative-free is the market and drug treatment. For a month-long treatment, the multidose package would seem to be the most appropriate solution, whereas the single-dose would be a more one-time treatment (e.g. following surgery) or for intermediate use. Unither customers can choose between BFS and multidose. Customers will make their decision as their projects progress through the clinical phases, via, for example, a dose-ranging study, during which they will determine the concentration of the product, the number of daily drops required and the time of treatment (in short, the dosage). At this point, they can use BFS or multi-dose containers. The stages of drug development Pharmaceutical companies are informed about how to prepare and submit a file to health authorities for an innovative drug. However, they are not necessarily informed about the studies and tests conducted during eye drops development (BFS or multidose). Others are less familiar, such as academics or small development companies, since they have never submitted a dossier to health agencies. In order to facilitate the application process for these groups, Unither has drawn up a summary diagram explaining the tests and studies to be carried out during the development phases of an eye drop product, from the pre-clinical phase (“pre-formulation study” on the diagram) to the increase in batch size for industrialization (“scale-up & industrialization”). Some fifteen development projects under discussion range from clinical phase to phase III and concern the Bordeaux, Coutances, Rochester or Amiens sites. Among these projects, three to four are pre-development projects in Bordeaux for future transfer to a BFS site. In order to perform these services, pilot workshops and/or mobile tanks dedicated to development are implemented at each site to perform these services. Unither’s expertise and know-how over more than 30 years also helps with these activities. Adaptability: from small to large batch sizes Companies looking for a CDMO to manufacture BFS or preservative-free multidoses will initially need small batch sizes, and then large batches for marketing and supplying the market. When they approach Unither, which is the market leader, these companies are usually surprised to see that Unither can produce such small batches. This is a valuable asset of the company. This large production capacity enables Unither to support both small and large companies by adapting its capacities to their customers’ needs. For example, the Coutances site can produce a small batch size of 3L and a batch size of 2000L. In Rochester, the smallest batch size is 25-30L for a maximum of 2,000L. Rochester’s smallest batch size is 25-30L for a maximum of 2000L. This is a very wide range and perfectly meets Unither’s customers’ needs. The processes are sometimes very specific, with several complex manufacturing phases. A single 3L tank is not enough, hence the importance of large production capacity. Close to the market Unither’s presence on four continents is an advantage, as some pharmaceutical companies only exist on one continent. If a French player wishes to do business with Unither, it will be supported by the knowledge that Unither is familiar with that market. This is just how it can be supported internationally if it grows and evolves. Unither’s impact is local and international. For example, many prospective customers contact Unither from South Korea, Singapore and Taiwan to develop products for the United States and Europe, which is why it is necessary to be based in both France and the United States. The fact that Unither has sites in all four corners of the world (Brazil, China, the USA and France) so customers can export internationally if they wish.
