The key to success? Sharing ideas with partners to create innovative ophthalmological products
With more than 25 years of our know-how in sterile product formulation, production and management, Unither Pharmaceuticals is a specialist in ophthalmic product manufacturing. Today, they offer a unique and innovative equipment for compounding and fill-finish of preservative free products into multi-dose bottle.
Natalia Servol, head of Ophthalmic business at Unither Pharmaceuticals, speaks to us about the preservative-free multidose.
What equipment UNITHER currently uses for Ophthalmic products?
We have a bunch of manufacturing equipment and versatile tank systems allowing us working on industrial machines and under GMP conditons from 3L to 2,000L batch sizes. Also, we offer a variety of ophthalmic moulds allowing us to fill large range from 0.25mL to 1.0mL. We can compound and fill solutions, emulsions, gels and others.
What Ophthalmic technologies do you offer?
Unither’s industrial engineering offers 3 main technologies for sterile manufacturing of ophthalmic products: Blow-Fill-Seal (BFS) in single unit vials, Preservative-free multidose (PFMD) and common Multidose (MD) for products with preservatives.
We are always looking for innovative solutions to meet our Customers’ requirements and Patiens’ needs. By building the industrial synergy between two main technologies for PF (preservative-free) ophthalmic products BFS & PFMD, we do believe providing our Customer with sustainable solutions and the Patients with tailored products to facilitate their life.
This is our driving force for creation and realization of an innovative PFMD manufacturing line.
Can you tell us more about the “Preservative-free multidose”?
We are proud and delighted of our cutting-edge PFMD line as this an embodiment of more than 25 years of sterile know-how, of uncountable hours of work of our teams together with external Suppliers and Customers.
By creating a synergy with unit-dose vials, the PFMD presentation acts as a complement to BFS and grants Patients with the continual security and product quality throughout the treatment period.
The PFMD product is manufactured under the aseptic process. The aseptic manufacturing and sterile fill-finish process is a process in which the drug product, container and closure/cap are first subjected to sterilization methods separately, as appropriate to each component and requirements, and then brought together by the isolator designed machine.
How did you come up with this idea?
The PFMD machine at Unither came to life from an idea, our Customers’ feedbacks and demands to meet Patients’ needs. Per today we work with two technologies: Aptar and Nemera. However, our Patient oriented philosophy let us foresee that new tailored solutions might come into the near future.
How do you answer to customers’ needs?
Every manufacturing plant has a dedicated R&D team and pilot work-shop for internal and Customer projects. If required, some works can be provided by or executed with the participation of our innovation & development centre from Bordeaux or the back-up manufacturing plant. So, our customers benefit from R&D and industrial international footprint of Unither from early works to commercial manufacturing.
We answer and meet international quality and regulatory standards. We are approved by European agency, FDA, ANVISA, Korean, Chinese MOH and many others. We work in an international environment, both for transversal project management and commercial supply.
What is coming next?
Plenty of exciting projects! Our R&D site from Bordeaux has made a strategic move and the whole team is working hard to turn our Bordeaux site into the R&D Center of excellence for Ophthalmology. We keep creating innovative solutions together with our Partners. Among many novelties, here, we’d like to mention Curecall, a start-up specialized in the monitoring of chronic ocular diseases – a user-friendly solution for Doctors and Patients.
We foresee great challenges in ophthalmic field and we do believe that vision science can overcome them by collaboration and free sharing of ideas within interdisciplinary teams Our credo: be open minded. We will be delighted to welcome you at ARVO and other specialized events. Stay tuned!
How can we reach you?
You can directly contact me for any business request:
You can also meet us at CPhI Worldwide 2021 (stand #4G12) and don’t miss us at ARVO 2022 (stand #2019) next year!